Friday, July 31, 2009

U.S. Supreme Court Decision May Impact Drug, DUI Cases

The United States Supreme Court recently handed down a decision in Melendez-Diaz v. Massachusetts that has sent a jolt through the system of prosecuting drug and alcohol cases. Before this decision, the strongest evidence in drug and drunken driving cases often was a piece of paper. That paper contained a crime lab or Breathalyzer report confirming that the defendant had illegal drugs or a high level of alcohol in his or her system.

The decision in Melendez-Diaz has changed that method of prosecution. In a 5-4 decision, written by Justice Scalia, the Court held that the reports of drugs or alcohol served as “witnesses” for the prosecution. And because the Sixth Amendment gives defendents a right to be confronted with the witnesses against them (the Confrontation Clause), Justice Scalia said that drug defendants and others are “entitled to be confronted with the (lab) analysts at trial.” This means that the prosecution has to make the lab technician that produced the drug or alcohol report available to testify at trial if the defendant demands it. Many lawyers think this ruling will have a substantial impact and one state, Virginia, has already called a special legislative session to change its laws.

“This is a train wreck in the making,” said Scott Burns, executive director of the National District Attorneys Association. “The Court is saying you can’t submit an affidavit saying that the cocaine is cocaine. The criminalist must be there to testify the cocaine is cocaine. Particularly in rural states and in smaller communities, this is going to be a major problem.”

For more information, see the article on the St. Louis Post-Dispatch website at:
http://www.stltoday.com/stltoday/news/stories.nsf/nation/story/2EF8EAACE3DF95F686257604000DEDEC?OpenDocument

See the U.S. Supreme Court Decision at:
http://www.supremecourtus.gov/opinions/08pdf/07-591.pdf

Labels: Breathalyzer, Confrontation Clause, Lab analysts, Scalia, U.S. Supreme Court

posted by Colleen at 7:31 AM

Updated Safety Information for Colchicine

FDA has now approved the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares. Previously, oral colchicine was used for many years without FDA approval.

Though the FDA has approved this drug, it points to two new safety issues. First, fatal colchicine toxicity was reported with certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. Drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity.

Second, data revealed that a substantially lower dose of colchicine was as effective as the higher dose traditionally used. Moreover, the lower dose is associated with significantly fewer adverse events compared to the higher dose.

Thus, the FDA recommends that patient with renal or heptic impairment not simultaneously use P-glycoprotein (P-gp) or strong CYP3A4 inhibitors and colchicine. Additionally, when possible doctors should opt to give their gout patients a lower does of Colchicin.

For more information please see: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174315.htm

Labels: claritromycin, Colchiine, Colcrys, familial Mediterranean fever, FMF, Gout

posted by Jessica at 7:21 AM

Mosquitoes used to deliver malaria ‘vaccine’

In a daring experiment in Europe, scientists used mosquitoes to deliver a "vaccine" of live malaria parasites through their bites to their victims.

The results were astounding: Everyone in the vaccine group acquired immunity to malaria; everyone in a non-vaccinated comparison group did not and developed malaria when exposed to the parasites later.

While using mosquitoes as vaccinators is impractical, the use of the live malaria parasites may be key to developing an effective traditionally-dispensed vaccine. One of the Study’s researchers, Dr. Robert Sauerwein, cautioned: "This is not a vaccine" as in a commercial product, but a way to show how whole parasites can be used like a vaccine to protect against disease”

The Study published in the New England Journal of Medicine capitalized on the facts that people can develop immunity to malaria if exposed to it many times and the drug chloroquine can kill parasites in the final bloodstream phase, when they are most dangerous.

The Study’s subjects where given chloroquine to protect them while they were gradually exposed to malaria parasites. Through this process, the subjects developed immunity.

Sanaria Inc. is in the process of testing a vaccine that uses live parasites.

New ways to prevent or treat malaria are needed because there is a growing resistance to artemisnin and chloroquine in areas heavily plagued by malaria outbreaks.

Malaria kills nearly a million people each year, mostly children under 5. The disease is spread mostly through mosquito bites.

For more information please see: http://content.nejm.org/cgi/content/full/361/5/468.

Labels: africa, artemisnin, chloroquine, Malaria, mosquito, vaccine

posted by Jessica at 6:42 AM

Thursday, July 30, 2009

FDA Advises Consumers Not to Use Body-Building Supplements that Contain Steroids

The FDA notified consumers and healthcare professionals yesterday not to use body-building products marketed as containing steroids or steroid-like substances. The products are marketed for increasing muscle mass and body building and are advertised as alternatives to anabolic steroids. The FDA warns that these products are marketed as dietary substances, but they are instead unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.

“Products marketed for body building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” said the FDA’s commissioner, Dr. Margaret Hamburg. The agency cent a letter to American Cellular Laboratories Inc., saying it markets and distributes drugs labeled as dietary supplements which are in fact unapproved drugs. To be a dietary supplement, a product has to contain one or more dietary ingredients, such as vitamins or minerals.

Over the past two years, the FDA has received 5 adverse event reports through its MedWatch reporting system directly related to steroid containing products. Some of the events reported include serious liver injury. No deaths were reported. The products affected by the warning are marketed by American Cellular Laboratories, Inc. and include: TREN-Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-40 Xtreme.

For more information, see the FDA News Release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174060.htm

See the MedWatch Safety Information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173983.htm

See the FDA Consumer Report at:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm173739.htm

See the article from CNN’s Website at:
http://www.cnn.com/2009/HEALTH/07/28/body.building.steroids/index.html?eref=rss_health

Labels: ACLU, body-building, FDA, liver damage, steroids

posted by Colleen at 6:04 AM

Wednesday, July 29, 2009

FDA Deems Mercury Level in Fillings Safe

Silver dental fillings containing mercury are safe for use by adults and children ages 6 and above, the Food and Drug Administration. Only people who are allergic to mercury should avoid that type of filling.

After reviewing more than 200 scientific studies, the agency concluded that mercury vapor released by the filling was not enough to cause brain damage. Still, the agency classified the fillings as a Class II or moderate risk medical device.

A Class II label allows the FDA to impose special controls to provide reasonable assurance of the safety and effectiveness of the device.

The special controls include: a warning against the use of dental amalgam in patients with mercury allergy; a warning that dental professionals use adequate ventilation when handling dental amalgam; and a statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor.

The FDA has previously warned on its web site about the filling’s potential risks for fetuses, breast-feeding infants and children younger than 6. The findings showed that the fillings do not expose those groups to mercury levels considered unsafe by the Environmental Protection Agency, but added that there were few studies on the effects of mercury in fillings on children under 6.

The filling, scientifically known as a dental amalgam, is a mixture of liquid mercury and a powdered alloy. The mercury and the alloy had previously been classified separately. The mercury component was considered a Class I or low risk device.

Silver dental filling is the least expensive type of filling, used in roughly a third of procedures to replace tooth decay.

For more information please see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173992.htm

Labels: cavity, dental, dental amalgam, Dentist, FDA, filling, mercury

posted by Jessica at 12:57 PM

Research Shows that Tanning Beds can be as Deadly as Arsenic

A study published in the medical journal, Lancet Oncology, has concluded that ultraviolet radiation coming from tanning beds is a top cancer risk, and is as deadly as arsenic and mustard gas.

A new analysis of twenty studies done by International cancer experts concluded that the risk of cancer jumps by 75 percent when people start using tanning beds before the age of 30. Experts also found that all types of ultraviolet radiation caused worry mutations in mice, which experts say is proof that radiation is carcinogenic. According to researchers, this new classification means tanning beds and other sources of ultraviolet radiation are definite causes of cancer, alongside with tobacco, hepatitis B virus, and chimney sweeping.

One of the cancer researchers, Vincent Cogliano stated that, “People need to be reminded of the risks of sun beds. We hope the prevailing culture will change so teen don’t think they need to use sun beds to get a tan.” Most lights used in tanning beds give off mainly ultraviolet radiation, which cause skin and eye cancer, according to the International Agency for Cancer Research.

As the use of tanning beds has increased among people under 30, doctors have seen a parallel rise in the numbers of young people with skin cancer. In Britain, melanoma, which is known as the deadliest kind of skin cancer, is now the leading cancer diagnosed in women in their 20s.
Cogliano cautioned that ultraviolet radiation is not healthy, whether it comes from a tanning bed or from the sun. The American Cancer Society advises people to try bronzing or self-tanning creams instead of tanning beds.

Labels: bronzing, self-tanning, skin cancer, tan, tanning beds, The American Cancer Society

posted by Chavon Williams at 11:39 AM

Tuesday, July 28, 2009

New FTC Rule Requires Doctors and Hospital to Check IDs

Elena Castro was finishing the paperwork to buy her first home when the bank called to tell her that there was a problem with her credit report, nearly $10,000 in unpaid hospital bills, that had been eating away at her credit score for years. The charges were for several ear, nose and throat procedures done at hospitals in her region, but they were not her charges. Castro soon discovered that a thief had used her personal information to obtain medical care.

Armed with as little as a stolen name, Social Security number and date of birth, an imposter can walk into a doctor’s office or hospital and receive services billed to the victim or the insurance provider. The Federal Trade Commission (FTC) reports that medical identity theft accounts for 1.3 percent to 3 percent of all identity theft crime, about 250,000 cases each year.

But, there is hope on the horizon; the FTC hopes to address a part of the problem with a new regulation called the Red Flags Rule, which is set to take effect on August 1. The rule would require physicians’ offices and hospitals, among other businesses to create a new protocol to spot the “red flags” of identify thief. These “red flags” include detecting fake or altered IDs, inconsistencies in a patient’s medical records or fraud alerts from consumer reporting agencies.

However, physicians are not happy with these changes. In nearly 100 letters to the FTC physicians argued that the rule imposes an “unjustified, unfunded mandate on physicians’” and could have “serious adverse consequences on patients’ access to health care. Dr. Ardis Hoven stated that the new regulations could “severely impact a doctor’s administrative work load.” “In my practice, patients arrive acutely ill. The last thing I want is my patient to be detained at the check-in desk when they’re having acute medical problems.”

The red flag regulation actually went into effect on November 1, 2008, but on August 1, penalties will kick in. Creditors, including doctors or hospitals will be slapped with a $3,500 fine foe each “knowing violation” of the rule.

For more information see: http://www.msnbc.msn.com/id/32175003/ns/health-health_care/

Labels: August 1, conumer fraud, emergency room ID, Federal Trade Commission, identiy theft

posted by Chavon Williams at 12:02 PM

Blue Food Dye Linked to Reduced Severity of Spinal Injuries

According to new research out of the University of Rochester Medical Center, the same blue food dye that is used in M&Ms and Gatorade may be able to be used to reduce damage caused by spinal injuries. The blue food dye contains a compound known as Brilliant Blue G (BBG). After researchers injected rats suffering from spinal cord injuries with BBG, the rats were able to walk again. The only side effect of the injection was that the rats temporally turned blue.

Researchers decided to try the BBG injections after a separate revelation about spinal cord injuries in 2004. In that year, scientists discovered that adenosine triphosphate, also known as ATP and is described as the “energy currency of life”, rushes to the injury site in the spinal cord soon after the cord is injured. This sudden surge of ATP to the spinal cells kills off healthy cells, making the injury far worse. Soon after this discovery, researchers also discovered that the spinal cord is rich in a molecule called P2X7. This molecule is known as the “death receptor” because it allows ATP onto motor neurons in the spinal cord and send the signals that eventually kill them.

Maiken Nedergaard, lead researcher and professor of Neurosurgery and director of the Center for Translational Neuromedicine at the University of Rochester Medical Center, knew that P2X7 could be deterred by BBG. Nedergaard also knew that BBG was similar to blue food dye, which was approved by the FDA in 1982. This gave Nedergaard the confidence to test BBG intravenously. The rats given BBG immediately after their spinal injury were able to walk with a limp. The rats that did not receive BBG never regained their mobility. The researchers say that it could be several years before this method is ready to be tested on humans.

For more information, see the article on CNN’s website at:
http://www.cnn.com/2009/HEALTH/07/28/spinal.injury.blue.dye/index.html?eref=rss_health

Labels: ATP, BBG, Gatorade, M and Ms, spinal cord, University of Rochester

posted by Colleen at 11:42 AM

Stevens-Johnson Syndrome Caused by Several Different Drugs

It's really disturbing to find out that some of the drugs our doctors prescribe, and even some of those we buy over-the-counter have the potential to cause serious disorders, disfigure us, and even cause death when taken in the recommended doses. But that's exactly the case with hundreds of commonly prescribed drugs, and many over-the-counter ones. One serious disease risk is Stevens-Johnson Syndrome (SJS), a condition that can cause sores anywhere on the body, including inside the mouth. SJS can kill the outer layers of skin, leaving the dermis exposed much like a 3rd degree burn after the skin has sloughed off.

If that isn't bad enough, Stevens-Johnson Syndrome is considered by some to be the mild form of Toxic Epidermal Necrolysis (TEN). Both have several causes, and some are unknown, but the majority of cases are caused by prescription medications such as the anticonvulsant phenytoin (Dilantin, Phenytek, Cerebyx). Some over the counter medications, NSAIDs (ibuprofen, for example), herbals (ginseng was identified), and illegal drugs like cocaine are also indicated as having caused SJS.

There are a number of types of drugs that can cause SJS, but not all within a class have been associated with this allergic reaction. The classes include over-the-counter NSAIDs such as ibuprofen and others and ginseng often found in herbal remedies. Prescription drugs include penicillins (antibiotics), phenytoins (anticonvulsants), sulfonamides (antibiotics), enzyme inhibitors, NNRTIs (to treat AIDS), antifungals, antihyperglycemics (to treat diabetes), azalides (antibiotics), and stimulant drugs.

If you notice any of these symptoms after starting any drug in these classes, notify you doctor immediately. If he doesn't seem concerned or if your symptoms get worse seek a second opinion, and ask about changing your medications. Should your doctor fail to respond timely and appropriately and you develop SJS or TEN as a result of your prescription(s) seek legal counsel regarding medical negligence.

The list of drugs is lengthy and taking multiple medications increases the risk of SJS. SJS is a serious, life threatening disorder. If you suspect you might have SJS, or have been given this diagnosis, you may be entitled to compensation. For a free, no-obligation consultation, please contact Schlichter, Bogard & Denton, the experienced pharmaceutical attorneys.

posted by Erica at 7:28 AM

Should Hospitals Have to Offer Long Term Care to Indigent Non-documented Immigrants?

Should Hospitals Have to Offer Long Term Care to Indigent Non-documented Immigrants

In a benchmark case dealing with the obligations of hospitals toward uninsured illegal immigrants, a Florida jury found that Martin Memorial Medical Center did not act unreasonably when it chartered a plane and repatriated a severely brain-injured Guatemalan patient against the will of his guardian.

Luis Jimenez, now 37, immigrated to the United States from Guatemala in order to support his family. But in 2000, a drunk driver crashed into a van he was riding in and left him a paraplegic. Martin Memorial Medical Center treated Jimenez for three years. For more than a year he lingered in a vegetative state. Now he has the mental capacity of small child. Over three years, Marin Memorial spent 1.5 million in Jimenez’s care.

In July 2003, Martin Memorial Medical Center chartered a private plane and sent Jimenez back to Guatemala without telling his relatives in the U.S. or Guatemala. Martin Memorial contends Jimenez wanted to go home and a state judge approved of sending Jimenez to Guatemala.

Montejo Gaspar, Jimenez’s cousin and legal guardian has sued the hospital for repatriating Jimenez. Lawsuit seeks nearly $1 million to cover the estimated lifetime costs of his care in Guatemala, as well as damages for the hospital’s alleged “false imprisonment” of his cousin.

The underlying question was what should a hospital do with a patient who requires long-term care, is unable to pay and doesn’t qualify for federal or state aid because of his immigration status. This appears to be the first time a lawsuit has been filed in such a case.

Just before jury deliberations, Senior Judge James Midelis told jurors that the only decision to be made was whether the hospital’s action were “unreasonable and unwarranted” under the circumstances. It has already been determined that Jimenez was “unlawfully detained and deprived of liberty” by the hospital and that the hospital had acted against the will of his legal guardian.

The all- White jury declined to comment on their verdict that the hospital did not act unreasonably in repatriating Jimenez to Guatemala.

http://www.nytimes.com/2009/07/28/us/28deport.html

Labels: Florida, Guatemala, health care reform, illegal immigrants, Luis Jimenez, Martin Memorial Medical

posted by Jessica at 7:19 AM

Monday, July 27, 2009

The Birth Control Pill may be Less Effective in Obese Women

New research shows that oral contraceptives may behave differently in the bodies of women who are obese, than in normal-weight women, thus suggesting that birth control pills may not work well in preventing pregnancy. According to the study published in the journal, Contraception, researchers say that there has been some evidence to suggest that the birth control pills may be less effective in obese women, but finding have not been consistent.

Researchers assigned twenty 18 to 35- year- old women, none of whom were using oral contraceptives, to take birth control for two cycles. Half of the women were obese, with body mass indexes above 30, while the other half were normal weight and had body mass indexes below 25. The women took pills containing ethinyl estradiol and levonorgestrel, which is a synthetic hormone used to regulate ovulation.

For the obese women, it took about 10 days of taking the pill for their blood levels of levonorgestrel to reach the optimum steady-state concentration for suppressing ovulation compared to about 5 days for the normal-weight women.

“The longer time to reach steady-state levels of levonorgestrel may represent a window of opportunity for the ovary to prepare to release an egg”, said research overseer Dr. Allison B. Edelman of Oregon Health and Science University in Portland. She further added that for one of the obese women it took 20 days to reach the steady state level, suggesting that ovulation may never have been adequately suppressed.

In spite of these findings, according to Edelman, “Additional studies are needed before [researchers can] recommend a change in clinical practice regarding the use of oral contraceptives in obese women.

Labels: birth control, body mass index, hormones, obesity, pregnancy, pregnant

posted by Chavon Williams at 11:41 AM

Chemical used in Hospital Plastic Tubing and Feeding Bags Linked to Increased Risk of Liver Problems in Premature Babies

A new study published today in the journal Pediatrics, links a chemical used in many plastic products to an increased risk of liver problems in premature babies. The study was conducted at a hospital in Germany. The study suggests that a chemical known as phthalate, which is used in some plastic intravenous feeding bags and tubing, may raise the chance of liver damage in babies that are born prematurely.

Premature babies have livers that are immature so they are already at risk for liver complications. Further, many times they are fed intravenously, a practice which is also known to increase liver problems. The study suggests that one possible reason for the increased liver problems with intravenous feeding is the chemical phthalate which is used in the tubing.

The study tracked 30 premature infants that were treated in the intensive care unit before the hospital switched to feeding equipment without the chemical, and 46 infants treated there afterward. Serious liver problems developed in 50% of infants fed with tubes containing phthalate versus only 13% of the other infants.

Some experts say the study is unconvincing, but others, such as Deborah Cory-Slechta, an environmental medicine professor at the University of Rochester medical school said, “This is a pretty strong damnation of” phthalates. “It needs to be replicated. But I still think this makes a very strong case for getting rid of these compounds” in infant intensive care units.

In a 2002 phthalates advisory, the FDA recommended alternatives for patients most at risk from the chemical leeching out of plastic medical equipment, including sick infant boys because of possible damage to developing reproductive organs. Some hospitals in the United States have already switched their feeding bags and tubing to items that do not contain phthalates. Further, some countries and California have restricted the use of phthalates. Phthalates can also be found in many other items besides medical supplies, such as toys, vinyl flooring and cosmetics. Phthalates are different from bisphenol-A, or BPA, a plastic-hardening chemical that also has raised health concerns and is found in food containers and other products. It's no longer used in many baby bottles.

For more information, see the article from MSNBC at:
http://www.msnbc.msn.com/id/32157844/ns/health-kids_and_parenting/

Labels: baby bottles, BPA, infant, liver damage, Pediatrics, Phthalate, premature

posted by Colleen at 11:30 AM

Agent Orange linked to serious heart disease

There may be a link between veteran’s exposure to the defoliant Agent Orange and other herbicides used during the Vietnam War and an increased chance of developing serious heart problems and Parkinson’s disease.

A study from the Institute of Medicine released Friday suggests there is a stronger connection than previously thought about the health risks to Vietnam veterans.

The Institute of Medicine, a division of the National Academy of Sciences, is mandated by Congress to review every two years evidence about the effects of Agent Orange exposure.

American forces sprayed millions of gallons of Agent Orange and other defoliants over parts of Vietnam from 1962 to 1970. Military authorities used the defoliants in an attempt to thin out the dense jungle the North Vietnamese forces used as cover.

American troops and others exposed to the chemicals later complained of numerous health problems. It is still not know the full extent of potential problems.

Researchers reviewed several studies that showed links between higher exposure levels of Agent Orange and greater incidence of ischemic heart disease, a condition involving reduced blood supply to the heart, and determined Vietnam veterans likely face an increased chance of ischemic heart disease.

Veterans exposed to the chemicals may be at a greater risk to develop ischemic heart disease even if they have other risk factors such as smoking, age, and weight.

The conclusion on Parkinson’s was based on a review of 16 studies that looked at herbicide exposures among people with the disease or Parkinson’s-like symptoms. But the results related to Parkinson’s disease are less certain because of the lack of studies specifically investigating Parkinson’s rates among Vietnam veterans.

The Veteran’s Affairs Department is reviewing the study in order to determine the full extent of the toxic effects of Agent Orange in an effort to give exposed Vietnam veterans the disability benefits they need to properly treat their condition(s).

For more information please see:

Labels: agent orange, heart disease, North Vietnamese, Parkinson's, Veteran, Vietnam

posted by Jessica at 10:32 AM

Complications from Transvaginal Placement of Surgical Mesh Patches Still Being Reported to FDA

More than three years after the recall of several surgical mesh patches the FDA is still receiving reports of complications associated with the transvaginal placement of surgical mesh from nine different mesh patch manufacturers. Additional mesh products were added to the recall in 2007.

Transvaginal placement of surgical mesh is a procedure used in both hernia repair and pelvic organ prolapse (POP,) in which an organ, such as the bladder, bowel, rectum or uterus drops from its natural position and puts pressure against the vaginal wall.

The FDA Public Health Notification states, "Hundreds of thousands of hernia repair operations are performed each year both with and without surgical mesh, and patients generally recover quickly and do well after surgery." It doesn't comment about the relative number or safety of POP surgeries.

Despite the relative safety of this surgical procedure, for those patients who develop complications, the outcomes can have a seriously detrimental impact on their lives. Complications can include erosion through the vagina, infection, pain, incontinence and other urinary problem and recurrence of the prolapse. Other complications can include pain due to vaginal scarring, painful intercourse, and injury to adjacent tissues including blood vessels, bladder, and bowels.

If you have experienced any of these complications after surgical placement of a mesh patch you may be entitled to compensation. For more information on your rights as a consumer, and for a free, no-obligation consultation, please contact Schlichter, Bogard & Denton, the experienced consumer product and medical device attorneys.

posted by Erica at 7:26 AM

Sunday, July 26, 2009

Several Brands of Baby Cribs Recalled Due to Entrapment and Falls

There is nothing as tragic as the death or injury of a child, except possibly knowing that it was avoidable. With so many consumer protection agencies and watch-dog groups active in the U.S. it's a wonder that a defective product ever finds its way to the market, but they do, by the thousands. One of the last items that we should have to worry about is a baby crib.

But a quick search of the Consumer Product Safety Commission's (CPSC) website reveals the disturbing truth about the many dangerous products that threaten our children. As a parent, you probably go to great lengths to be sure you keep your children safe. Learning that the crib your children have been using could cause them injury, disfigurement or even death is disconcerting.

Among the types of baby crib accidents and injuries reported to the CPSC are falls due to an insufficient distance (less than 26") between the mattress mount and the top of the railing. Toddlers have been able to climb over the railing, and then fall to the floor. Other hazards are associated with either a mattress mount or a side-rail track coming loose. In both situations a gap is created between the mattress and either the railing or bed frame in which the child can become entrapped and suffocate or strangle.

One brand of crib uses a mesh side rather than rails. If the mattress isn't zipped to the mesh the child can fall between the mattress and mesh and suffocate. In other cribs children can break the slats, leaving not only a gap that they can get caught in, but the broken edge of the slat exposed. Other brands use spindles that are set too far apart and create a gap that can entrap a child.

Product manufacturers know that to market their products in the United States, they have a number of regulations they have to meet, depending upon their niche. The FDA, CPSC, and EPA are among the most obvious. When a manufacturer fails to meet the products minimum safety requirements, they may be held liable when their product causes an injury.

If your child is among those that have been injured from one of these cribs, please contact Schlichter, Bogard & Denton. We have experienced consumer product attorneys who are familiar with the brands of cribs that have been recalled, as well as a track record of success with consumer product liability claims.

posted by Erica at 7:24 AM

Saturday, July 25, 2009

ST. Louis Based SportsPlay Playground Equipment Recalled for Dangerous Lead Levels

In yet another effort to protect children from lead exposure, the Consumer Products Safety Commission (CPSC) has recalled 14 playground models distributed by the St. Louis based company, SportsPlay, Inc. and manufactured by Floteks of Turkey.

Recalled playground equipment includes four models of the Tot Town Fun Center, four models of the Tot Town Castle Fun Center, the Tea Cup Merry Go Round, 8' Web Climber, Rope Wall, two models of the Four Panel Circular Aztec Climber and Three Panel Aztec Climber. These playgrounds sold throughout the United States between January 2003 and December 2007.

In 2008 the U.S. Congress responded to the flood of imports, many from China that contained dangerous lead levels and other dangerous contaminants, by passing the Consumer Product Safety Improvement Act (CPSIA). The CPSIA, which went into effect February 10, 2009 contains new more stringent requirements for lower levels of lead, lead testing, and lower levels of other contaminants.

Children exposed to the dangers of lead poisoning can suffer serious irreversible damage to their physical and mental development, brains, nervous systems, and behaviors. They can easily become exposed as paint or lead containing parts chip and break, and particles are ingested.

If your child has been placed at risk from playing on one of these playgrounds please contact Schlichter, Bogard & Denton, experienced consumer product liability attorneys.

posted by Erica at 7:23 AM

Friday, July 24, 2009

iPod Warning: Your Device May Catch on Fire

Seattle n

ews station, KIRO-7 TV, reported today that records from the U.S Consumer Product Safety Commission (CPSC) indicate that a number of users have reported Apple iPod fires and overheating, which could result in property damage, burns and other personal injury.

Over 800 pages of documents were recently released by the CPSC, more than seven months after a Freedom of Information Act request was filed requesting information about all reports involving iPod burns and fires. Apparently, for the past seven months Apple attorneys have been filing exemptions to keep these documents from being released to the public. The documents detail numerous incidents where iPods began to smoke, burst into flames, overheat and in some cases cause injury to users.

The CPSC records reveal at least 15 cases of iPod overheating and fire-related incidents. Some of the cases involved iPods catching on fire in the room of sleeping teenagers, sending parents rushing into their rooms after hearing the sound of smoke detectors going off. To date, there have been no serious injuries reported. However, there is an Apple iPod lawsuit pending in Cincinnati. The parents of a 15-year-old-boy allege that a 16GB iPod Touch exploded in his pocket while he was sitting at his desk at school. According to the complaint, the iPod burst into flames, burned his pants, melted his underwear and burned his leg, resulting in second-degree burns.

As of right now, iPods continue to be sold and a recall has not yet been issued.

Labels: burns, ipod, ipod dangerous, ipod injury, KIRO, Seattle, U.S. Consumer Product Safety Commission

posted by Chavon Williams at 1:10 PM

Airman Losses Legs after Botched Surgery

First Class Airman, Colton Read, lost parts of both of his legs and is in critical condition after a routine gallbladder surgery at Travis Air Force Base went terribly wrong, said members of his family.

Read was supposed to get his gallbladder remove laparoscopically via a small incision. However, during the procedures, surgeons nicked or punctured an aorta, a large artery that carries blood from the heart through the body, stated Read’s wife. Although the surgeons repaired the breach enough to save Read’s life, the repair began leaking and disrupted the blood supply to the legs, family members stated.

Read was flown to UC Davis Medical Center in Sacramento, California, where doctors told the family that the damage from the lack of blood required amputation. Family members say that Read has undergone ten surgeries to remove dead tissue from his legs, leaving him without much of his right leg and the lower portion of his left. According to Read’s wife, Read still has not had his gallbladder removed because of the surgery complications.
Travis Air Force Base officials have not commented on this incident, but the case is under investigation by the base, a national hospital accrediting commission and the U.S. surgeon general.

Labels: Airman, amputation, gallbladder, Sacramento California, UC Davis Medical Center

posted by Chavon Williams at 12:57 PM

Schlichter, Bogard & Denton Files Yasmin/Yaz Lawsuit

Attorneys at Schlichter, Bogard & Denton file Yasmin/Yaz lawsuit

Date Released: 07/24/2009 St. Louis, MO – The attorneys at Schlichter, Bogard & Denton, L.L.P. filed suit this week in Iowa federal court against Bayer alleging that Bayer’s oral contraceptives Yasmin and Yaz are defective and present an increased risk of injury to women. Their client represents her daughter who at the age of 23 died suddenly of multiple bilateral pulmonary embolisms after using Yaz for only 8 months. The client’s daughter was engaged to marry her high school sweetheart. She had also just graduated from college and was to start her first post-graduation position a scant three days after her sudden death. An avid swimmer, plaintiff’s daughter was named to an All American Swim Team three times and gave swim lessons through the American Red Cross. She is survived by her fiancé, parents, two siblings, grandparents, aunts, uncles and cousins.

The lawsuit alleges that Bayer failed to warn the client’s daughter and their physicians of the increased risk of injury, while over-promoting the benefits of the drugs. In October of 2008, the Food and Drug Administration (FDA) sent Bayer a warning letter objecting to its television ads claiming that Yaz has additional benefits compared to other oral contraceptives. The FDA’s letter warned that Yaz actually has additional risks because it contains the progestin drospirenone. The warning prompted an agreement for Bayer to spend $20 million on corrective ads.

Both Yasmin and Yaz have been associated with heart attacks, deep vein thrombosis, pulmonary embolism, stroke and even death in young women.

Schlichter, Bogard & Denton attorneys Roger Denton, Kris Kraft and Beth Wilkins are experienced in litigating dangerous birth control product liability cases. Mr. Denton, Ms. Kraft and Ms. Wilkins are also vigorously litigating suits against the makers of Ortho Evra and NurvaRing in addition to Yasmin/Yaz. Schlichter, Bogard & Denton are lead attorneys on the NuvaRing MDL.

Currently only a handful of Yasmin/Yaz cases across the country have been filed against the manufacturer. Not only are Mr. Denton, Ms. Kraft, and Ms. Wilkins pioneers in these suits across the country, they are also leading their firm’s Yasmin and Yaz litigation and expect to file additional lawsuits in the coming weeks.

Media Contact: Kristine Kraft Schlichter, Bogard & Denton, L.L.P. Phone: 314.621.6115 kkraft@uselaws.com www.uselaws.com

Labels: athlete, Bayer, bilateral pulmonary embolism, death, Deep Vein Thrombosis, DVT, heart attack, Iowa, stroke, YAZ

posted by Jessica at 12:39 PM

St. Louis Based Doe Run Co. Being Investigated by Missouri Attorney General for Environmental Cleanup Efforts

Doe Run Co., a St. Louis based corporation, is being investigated by the Missouri Attorney General’s office for its cleanup of mine tailings in St. Francois County. Residents of Leadwood, Missouri have complained about Doe Run’s efforts to clean up six piles of mine tailings as part of the Big River Mine Tailings/St. Joe Minerals Corp. Superfund project.

Most of the complaints concern the adequacy of Doe Run’s work in removing lead contaminated soil in the area as well as the company’s use of biosolids and sludge to promote vegetation growth on the cleaned soil. Biosolids are treated sewage sludge that can be used as fertilizer. For example, the company has recently deposited a collection of cow bones and ear tags on a person’s property to help begin vegetation growth on that property.

Residents of Leadwood have become so concerned with the cleanup process that they have contacted environmental activist Erin Brockovich, who has become well known for her activism since the 2000 movie bearing her name was released. Brockovich has since launched an investigation and sent Robert Bowcock, her head environmental investigator, to Leadwood on Monday to hold a community meeting. Bowcock told the community Monday that Doe Run’s clean-up efforts have actually worsened the contamination for the city, because through the clean up, Doe Run has exposed the residents to lead dust.

Doe Run’s cleanup work is being overseen by the Environmental Protection Agency (EPA). EPA officials have stated that they have approved the use of biosolids at both the Leadwood and Desloge, MO clean up sites. They also said that material from a portable toilet company is used at the Desloge pile and the primary source for the material at the Leadwood pile is the Rock Creek Sewer District in Jefferson County.

Schlichter, Bogard & Denton is currently representing the plaintiffs in a lawsuit against Doe Run Co. for its alleged contamination of a town in Peru.

For more information, see the St. Louis Post-Dispatch article at:
http://www.stltoday.com/stltoday/news/stories.nsf/sciencemedicine/story/13BAA7E5B8240094862575FD0007A66A?OpenDocument

Labels: biosolids, Doe Run, EPA, Erin Brockovich, lead, Leadwood, sludge

posted by Colleen at 8:08 AM

Denture Cream Users Developing Neurologic Disorders

Denture creams that contain zinc have been identified as a potential health risk. A review of the product FAQ sheets for PoliGrip® and Fixodent® would lead anyone to think they are perfectly safe. But a study by the University of Texas Southwestern Medical Center, University of Colorado Health Sciences Center, and the Mayo Clinic indicates that these product sheets are misleading because people using the products are developing neurologic disorders.

The study measured high levels of zinc in the products used by their test subjects. The amounts used for even one recommended application are 3.5 times to 7 times the recommended daily intake for women and 2.5 times to 5 times that recommended for men. The concentrations of 17 mg to 34 mg per gram are already higher than the amounts recommended for women (8 mg) and men (11 mg), but one application takes about 1.6 grams of denture cream. If one's dentures need securing a second time during the day, it can cause the user to exceed the toxic levels of zinc set at 80 mg/day.

On the bright side, some of the patients in the study showed some improvement of their neurological damage when they quit using zinc-containing denture creams. But some improvement is not the same as full recovery.

No one should have to worry about suffering the loss of essential neurological functions because they used a product that promotes itself as safe. Zinc toxicity can cause neuropathy that affects sensation or mobility, and causes pain, numbness, pins-and needles sensations or paralysis in arms, hands, legs or feet, or loss of balance when walking. It can affect blood pressure, heart rate, and other autonomic functions such as perspiration, bowel movement, bladder control, and even cognition (mental function.)

If you have experienced any of these symptoms and have used a denture cream containing zinc, switch to a product that does not contain zinc. For more information on your rights as a consumer, and for a free, no-obligation consultation, please contact Schlichter, Bogard & Denton, experienced consumer product attorneys. You may be entitled to compensation for your losses.

posted by Erica at 7:18 AM

The faster you walk, the longer you live

Strong medical evidence shows the faster we walk, the fewer health problems we will have and the longer we will live.

How active should we be? Ten thousands steps is a popular number- a number suggested by a Japanese marketing campaign. Most Japanese people ages 65 to 74 meet the daily goal.

Many Americans do not come close to reaching that goal. The average white older adult walks slightly more than 5,000 steps a day and the average older African-American, about 3,800 each day. Middle-aged Americans come the closest and average around 9,622 steps each day. However, middle-aged Americans with type 2 diabetes only walk 6,600 step a day despite the fact exercise may improve their condition.

However, a Harvard study suggests that 6,000 steps a day can make a difference. Dr. Ralph Paffenbarger studied 17,000 Harvard alumni who were between 53 to 90 in 2001. He found that men who walked briskly nine or more miles a week had a 21% lower risk of death from heart disease than those who walked less than three miles a week.

If the thought of walking 10,000 or even 6,000 steps is overwhelming, start slowly. Another study suggests that the health of those who are disabled and elderly improves simply if they walk to and from the mailbox instead of staying in the house.

Increasing physical activity keeps us healthy as we age.

For more information please see: http://www.time.com/time/magazine/article/0,9171,146774,00.html or

http://www.stltoday.com/stltoday/lifestyle/stories.nsf/healthfitness/story/0D619C1A6B4D238D862575FB006CD8C4?OpenDocument

Labels: excercise, Japanese, Steps, Walk

posted by Jessica at 6:32 AM

Thursday, July 23, 2009

FDA Warns Against the Use of E-Cigarettes

We previously reported on the new use of “e-cigarettes”, a battery powered device that contains cartridges filled with nicotine and other chemicals and are spiced with flavors such as chocolate, cola, or bubble gum. Manufacturers of e-cigarettes, such as Smoking Everywhere, advertise them as a “healthy” way to smoke. The FDA announced yesterday, however, that a laboratory analysis of e-cigarettes revealed that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

E-Cigarettes have not been submitted to the FDA for evaluation or approval, so the FDA has no way of knowing what exactly is in the cigarettes. The only way the FDA can determine the levels of nicotine or other chemicals in the devices is through the limited testing that the FDA has completed. The cigarettes do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. Not only is the FDA concerned about the carcinogenic chemicals it found in the cigarettes during lab testing, it is also concerned about the fact that the device is marketed and sold to young people through its availability in a variety of flavors. Experts have expressed concern that the e-cigarettes could increase nicotine addiction and tobacco use in young people.

Anyone that suffers an adverse event or product quality problems through the use of e-cigarettes, they should be reported to the FDA’s MedWatch Adverse Event Reporting Program at http://www.fda.gov/Safety/MedWatch/default.htm.

For more information, see the FDA Press Release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm

See the CNN News Story at:
http://www.cnn.com/2009/HEALTH/07/22/ecigarettes.fda/index.html?eref=rss_health

Labels: carcinogen, diethylene glycol, E-Cigarettes, FDAm nicotine

posted by Colleen at 3:56 PM

Reglan® and Drugs Containing Metoclopramide a Major Cause of Tardive Dyskinesia

The FDA has issued an order that the manufacturers of Reglan® place a black box warning describing serious drug side effects on all formulations containing metoclopramide of the risk of tardive dyskinesia developing from taking high doses of this drug or taking the drug for longer than 90 days. Patients most vulnerable to this risk are women, particularly elderly women, and those whose total cumulative dose is high.

The FDA is also requiring the manufacturer to submit a "Risk Evaluation and Mitigation Strategy" (REMS). This is a plan to inform health care professionals of the risks, the need to assess the risks in relation to the benefits of taking this drug, a method of assessing this risk to benefit relationship, and the need to inform the patient of the risks of taking this drug.

Tardive dyskinesia presents with involuntary muscle movements similar to Parkinson's disease. Jerking and twitching of facial muscles and limbs, including grimaces, protruding the tongue, blinking, and other facial distortions are among the symptoms. Tardive dyskinesia is untreatable, though the symptoms may decrease over several months following the final treatment with the causative drug. Rarely do the symptoms reverse completely.

The FDA originally approved Reglan® and metoclopramide for use prior to learning how many cases of tardive dyskinesia would result from its use. This outcome is associated with use longer than 90 days and high doses. After receiving numerous reports of new cases, the FDA issued these orders in an effort to prevent further adverse outcomes. For consumers, this is a clear signal about how dangerous this medication is.

It is the physician's responsibility to inform patients of the risks and benefits of medications they prescribe. If you are one of those affected by this medication, and particularly tardive dyskinesia, please contact Schlichter, Bogard & Denton, Pharmaceutical Attorneys in St. Louis, Missouri for a no-obligation, free consultation.

posted by Erica at 7:17 AM

Wednesday, July 22, 2009

New Lupus Drug may have Passed Key Test

After over 50 years of waiting for a new lupus treatment, researchers may have developed can reduce the symptoms of the life-threatening autoimmune disorder that afflicts as many as 1.5 million Americans.

Lupus is a chronic inflammatory disease in which the body's immune system attacks its own tissues and organs. About 90% of patients are women, usually in their 30s and 40s when it first strikes. Typical symptoms can include fatigue, fever, joint pain, stiffness and swelling, rashes, skin lesions, mouth sores, hair loss and chest pain. The disease can attack many internal organs, leading eventually to death.

In unpublished results released by the Human Genome Sciences company said that the experimental drug Benlysta significantly reduced lupus symptoms in a randomized trial of 865 patients, reducing their need for steroids and improving quality of life.

The new trial was conducted in 865 patients at 90 sites in 13 countries, primarily abroad. Patients all had active lupus, although none had a severe form requiring hospitalization, and received normal care for the disease. The participants were randomly placed into three groups, two receiving different amounts of the drug and the third receiving a placebo. Patients were given an infusion of the drug at the beginning of the trial, at two weeks, at four weeks, and then every four weeks after that. They were followed for 52 weeks.

About 58% of patients who received the highest dose of Benlysta showed a significant improvement on an index used to assess impact, compared with 46% of those receiving the placebo. More of the patients receiving the drug were able to reduce their prednisone intake, and most reported a better quality of life, although specific numbers were not provided.

About 6% of both patients receiving the drug and those on the placebo suffered side effects, including headache, joint pain and infections.

Experts cautioned that the results have not been peer-reviewed or published in a journal; the significance of this study is unknown at this time. Human Genome Sciences said the results will be published after a second study is completed.

Only three drugs are approved for treating lupus -- aspirin, the steroid prednisone and the antimalarial drug Plaquenil (hydroxychloroquine) -- and all were approved over 50 years ago during the Eisenhower administration. All can have severe side effects, including stomach bleeding for aspirin; weight gain, bruising, high blood pressure and diabetes for prednisone; and vision problems and muscle weakness for Plaquenil.

Benlysta is a monoclonal antibody known generically as belimumab. It is an immune protein produced artificially, which then binds to and blocks the activity of a protein called B-lymphocyte stimulator. Human Genome Sciences discovered the protein. Elevated levels of B-lymphocyte stimulator are believed to contribute to the production of antibodies that attack the patient's own organs.

For more information please see: http://www.hgsi.com/belimumab.html

Labels: aspirin, Benlysta, lupus, plaquenil, prednisone, treatment

posted by Jessica at 11:54 AM

Radon Found in Homes May Cause Lung Cancer Risk

New studies reported by a United Nations committee on Tuesday, have found direct evidence of a lung cancer risk from the presence of radon gas in many homes. Officials on the United Nations Scientific Committee on the Effect of Atomic Radiation (UNSCEAR) said these studies provided the first quantifiable evidence of the risk in homes from radon, which has long been seen as a potential health risk. Twenty studies were done involving tens of thousand of lung cancer patients in North America, Europe, and China.

In a statement released by Wolfgang Weiss, UNSCEAR’s vice chairman, he stated that, “Radon has been a typical health risk [that] no one wants to accept or take note of.” “We’ve done 20 studies in homes where concentrations are very low, and there we can see a risk, it is small, but it is certainly there.”

Radon is a hard-to-detect radioactive, noble gas that comes from natural decay of uranium. It is colorless and odorless and can accumulate in buildings, seeping from the group through cracks in cellars. It may also be emitted by spring waters and hot springs.

For more information see: http://www.msnbc.msn.com/id/32028728/ns/health-cancer/

Labels: cancer risk, noble gas, radioactive, radon, United Nations

posted by Chavon Williams at 10:26 AM

Baxter Warned to Cease Making False Claims About the Efficacy of TISSEEL

Mary A. Malarkey, Director of the Office of Compliance and Biologics Quality, representing the Department of Health and Human Services (DHHS) wrote a warning letter dated April 14, 2009 to Baxter International, Inc., with a 10-day demand that Baxter prepare accurate promotional and instructional materials regarding its hemostatic agent TISSEEL®, and inform the DHHS of its plan to disseminate the corrected information to all audiences to whom it originally disseminated the misleading information.

Although the DHHS and FDA found no fault with TISSEEL®, the DHHS warning to Baxter concerned Baxter's multi-focal effort to present false and unsubstantiated claims that TISSEEL® is more effective than it is, and that it is superior to competing products. The sources cited as evidence of these claims do not, in fact, contain any data, research results or even clinical evidence to back up Baxter's claims, which were promoted through three channels:

TISSEEL® National Accounts Presentation,
TISSEEL® General Surgery Brochure and
TISSEEL® Cardiac Sell Sheet

Some of the statistics used to indicate the effectiveness of TISSEEL®, as approved by the FDA in 2006, were not only incorrect, but referred to studies done using an earlier FDA approved formulation of TISSEEL® from 1998. These statistics were inflated.

Because physicians make decisions based upon their faith in the accuracy of a pharmaceutical company's representation of each product it produces, and patients are subject to the decisions of their physicians in situations that occur during surgery, it is imperative that the information be accurate, and not misleading in any way.

If you have been treated with TISSEEL® and have suffered any injuries or consequences because of the decision to use this product, you may be entitled to compensation. The experienced pharmaceutical injury lawyers at Schlichter, Bogard & Denton have long record of successful claims. Please contact Schlichter, Bogard & Denton, pharmaceutical attorneys, for a no-obligation consultation regarding your pharmaceutical injury claim.

posted by Erica at 7:14 AM

Clayton Based Brown Shoe Co. Recalls Certain Children's Shoes Due to Choking Hazard

The U.S. Consumer Product Safety Commission announced yesterday that Brown Shoe Co., a Clayton, Missouri based company, is voluntarily recalling 1.4 million pairs of Clog Children’s Shoes made by Buster Brown, a division of Brown Shoe Co. The recall was initiated after Brown Shoe Co. received two reports of decorative wheels on the shoes detaching, which could pose as a choking hazard for young children.

The shoes are a plastic-molded clog that are designed to be worn by kids in the water. The shoes are also designed to resemble a car. The shoes being recalled come in red, brown, blue, yellow, or pink and have the words “CARS”, “Transformers Animated”, or “Barbie” displayed on the outside of the shoe. The name of the Brown Shoe division, Buster Brown, is also listed on the inside of the shoe at the heel. The shoes were originally sold in children sizes 5-13 and youth sizes 1-3 at a variety of retail stores including, Famous Footwear, Sears, Target, and Wal-Mart, from August 2007-June 2009. While there have been reports that the decorative wheels can detach from the shoe, there have been no injuries yet reported.

For more information, see the St. Louis Post-Dispatch article at:
http://www.stltoday.com/stltoday/news/stories.nsf/stlouiscitycounty/story/B75721E55314DB35862575FA0068FFBB?OpenDocument#tp_newCommentAnchor

See the U.S. Consumer Product Safety Commission’s Recall Notice at:
http://www.cpsc.gov/cpscpub/prerel/prhtml09/09281.html

Labels: Barbie, Brown Shoe Co., Buster Brown, CARS, children, Shoes, Transformers, U.S. Consumer Product Safety Commission, wheels

posted by Colleen at 7:12 AM

Tuesday, July 21, 2009

Beach Sand Can Carry Nasty Diseases

Typical beach fun includes burrowing in the sand and burying fellow beach goers. But a new study shows that some pretty nasty bugs may lurk in the seemingly harmless sands.

The study, published in the American Journal of Epidemiology, found that kids under the age of 11 who dug in the sands were 44 percent more likely to develop diarrhea. And kids who were buried in the sand were 27 percent more likely to develop diarrhea than those who weren’t.

The study focused on 27,000 beachgoers who visited seven beaches around the country between 2003 and 2007. Three hundred and six children, or 6 percent, developed diarrhea. All of the children recovered on their own.

All of the beaches included in the study were all within seven miles of a sewage treatment plant.
However, other studies that focused on beaches far from sewage treatments plants still had high levels of E. coli and Enterococcus bacteria in the top 8 inches. In fact, levels can be almost 40 times those found in the water at the same beaches.

Beaches become contaminated from storm sewer runoff or from animal feces. Once the germs are there, the sand provides a very friendly environment for the bugs to replicate.

When the researchers looked at their data by location, they found that some beaches were far worse than others. Huntington Beach, which is on the shores of Lake Erie in Bay Village, Ohio, had no increase in the risk of diarrhea, while Fairhope Beach, which is on the shore of Mobile Bay in Fairhope, Ala., had an increase of almost 200 percent among those who dug in the sand.

Dr. Philip Kazlow, director of pediatric clinical gastroenterology at NewYork-Presbyterian Morgan Stanley Children's Hospital suggests using hand sanitizer and not ingesting the water or sand from beaches. The only way to get a gastrointestinal disease is to ingest the germs.

For more information please see: http://aje.oxfordjournals.org/cgi/content/abstract/170/2/164

Labels: Beach, children, diarrhea, Family, Sand

posted by Jessica at 11:29 AM

FDA Approves the Seasonal Flu Vaccine

The FDA approved the ordinary seasonal flu vaccine on Monday and stated that Americans should plan to get vaccinated. Vaccines against seasonal flu usually become available in September or October and flu experts say it is worthwhile to be immunized as late as January, since the U.S. influenza season usually peaks in February.

This year will be different since the new H1NI swine flu virus has been circulating and companies are working to make a separate vaccine against the pandemic strain. In a statement released by the FDA, they stated, “The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization on June 11, 2009.” The FDA further stated that, “Although this year’s seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for those Americans for whom it is recommended to receive the seasonal influenza vaccine.”

According to the United States government, between 5 and 20 percent of the United States population develops influenza each year. More than 200,000 are hospitalized from its complications and about 36,000 people die. Six companies manufacture the seasonal flu vaccine for the United States: GlaxoSmithKline Plc, ID Biomedical Corp, Novartis AG, Sanofi-Aventis SA, AstraZeneca, and CSL Ltd.
For more information see: http://www.msnbc.msn.com/id/32010750/ns/health-cold_and_flu/

Labels: FDA, flu vaccine, government, influenza, pandemic, swine flu

posted by Chavon Williams at 10:52 AM

Certain Gel-Filled Teethers are Recalled

Luv N’ Care Ltd, a Monroe, Louisiana based corporation, is initiating a recall of their gel-filled teethers with the brand names “Nuby”, “Cottontails”, and “Playschool.” The products are being recalled because of a finding by the FDA that two lots contained Bacillus subtilis and Bacillus circulans in the gel. While generally these bacteria do not cause illness in adults, children have weakened immune systems and can get sick if the teether is punctured and the gel is accidentally ingested.

If the bacteria are ingested by a child, it can cause stomach pain, vomiting, diarrhea, and sometimes more serious disease. However, no illnesses have been reported to date. The company distributed the products through retail outlets nationwide, and have also been marketed on the internet. The company has discontinued production of the teethers and is urging consumers to return the teethers for a full refund.

The recall involves the following products:
UPC code Brand Name 48526-00451 Nuby48526-00452 Nuby48526-00453 Nuby48526-00454 Nuby48526-00455 Nuby48526-00459 Nuby48526-00467 Nuby48526-00472 Nuby48526-00473 Nuby48526-00482 Nuby48526-00483 Nuby48526-00487 Nuby48526-00490 Nuby48526-00519 Nuby48526-00521 Nuby41520-87115 Cottontails50428-91511 Playschool41520-91660 Cottontails

Consumers with questions may contact the company at 1-800-256-2399 ext. 3106 between 8 a.m. and 5 p.m. central time.
Adverse reactions experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.
For more information, see the MedWatch safety information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172712.htm

See the FDA press release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172713.htm

Labels: bacillus subtilis, bacteria, FDA, Luv N Care, Playschool, teething

posted by Colleen at 10:32 AM

Monday, July 20, 2009

Government Officials May Lift HIV Travel Ban

Foreigners who have HIV may be allowed to travel and immigrate to the United States under a plan proposed by federal health officials that will lift a 22- year-old ban on infected visitors.

Officials at the Centers for Disease Control and Prevention (CDC) are seeking public comment through August 17, 2009 on the proposal, which would remove HIV from the list of diseases that can bar entry to the county and do away with HIV testing as part of medical exams for permanent residence and, in some cases, travel visas.

“We’re trying to end the stigma and the discriminatory practice for a disease that doesn’t warrant exclusion for coming into this country”, said Dr. Martin Cetron, director of the CDC’s Division of Global Migration and Quarantine. “We have to appreciate this is not a threat we face from abroad.”

While infectious disease experts and AIDS advocates are cheering this proposal on, immigration critics say they are leery of this proposal which could allow an average of 4,275 HIV-infected people into the country annually, with a lifetime medical cost of about $94 million for those admitted during the first year, according to the CDC estimates published in the June issue of the Federal Register. Others are concerned that HIV-positive visitors and immigrants will spread the disease.

As it stands now, HIV is among several diseases that require exclusion, including active tuberculosis, infectious gonorrhea, syphilis and infectious leprosy. Also on the lists are little-known sexually transmitted conditions such as chancroid, lymphogranuloma venereum or LGV, and granuloma inguinale. CDC officials said they may consider removing these conditions in the future, but wanted to move first to align health regulations with the new HIV statute.

For additional information see: http://www.msnbc.msn.com/id/31910664/ns/health-aids/

Labels: Center for Disease Control, Federal register, HIV/AIDS, immigrants, travel ban

posted by Chavon Williams at 7:32 AM

Friday, July 17, 2009

FDA Reviews Safety of Asthma Drug Xolair

The U.S. Food and Drug Administration has announced a safety review of Xolair (omalizumab), a drug used to treat moderate-to-severe persistent asthma in adults and adolescents.
Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The manufacturer’s long term evaluation study’s interim results have suggested an association between using Xolair and these adverse events. The study is being conducted by the manufacturer, San Francisco-based Genentech Inc.
The Early Communication is part of the FDA’s commitment keep the public informed about its ongoing safety reviews of drugs. Though the review focuses on potential adverse events, the FDA is not advising a change in prescribing or use of the drug at this time.
For more information please see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172399.htm

Labels: Asthma, FDA, Genetech, heart attack, heart failure, heart rhythm, stroke, Xolair

posted by Jessica at 7:40 AM

FDA Reviews Safety of Asthma Drug Xolair

The U.S. Food and Drug Administration has announced a safety review of Xolair (omalizumab), a drug used to treat moderate-to-severe persistent asthma in adults and adolescents.

Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The manufacturer’s long term evaluation study’s interim results have suggested an association between using Xolair and these adverse events. The study is being conducted by the manufacturer, San Francisco-based Genentech Inc.

The Early Communication is part of the FDA’s commitment keep the public informed about its ongoing safety reviews of drugs. Though the review focuses on potential adverse events, the FDA is not advising a change in prescribing or use of the drug at this time.

For more information please see:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172399.htm

Labels: Asthma, FDA, Genetech, heart attack, heart failure, heart rhythm, stroke, Xolair

posted by Jessica at 7:05 AM

Thursday, July 16, 2009

Popular heart bypass technique may pose risk

Popular heart bypass technique may pose risk
A common method used in heart bypass surgery spares patients pain and problems upfront but seems to raise their risk of dying or suffering a heart attack over the next three years.

In heart bypass surgery, doctors remove a leg vein that moved to the chest to create detours around clogged heart arteries.

For decades, the leg vein was removed with a long incision — sometimes groin to toe. This technique referred to as "open harvesting" is painful, leaves big scars and often led to infections and longer hospital stays.

About 13 years ago, doctors began using a new way by making small "porthole" cuts and using a tiny scope and tools to tunnel along the vein and pull it out through the small openings. This technique, "endoscopic harvesting," is very popular. Of the approximately 450,000 bypass operations done each year in the US, 70 percent use the less invasive method.

However, the study recently published in the New England Journal of Medicine found that patients treated with the endoscopic harvesting method were significantly more likely to die, suffer a heart attack or need another artery-opening procedure in the following three years. The likely reason is that the vein suffers damage from being pulled out, so it doesn't hold up well over time.

The study involved 3,000 patients at more than 100 sites around the country who had been part of another study testing an experimental drug. Because its primary aim wasn't to evaluate the leg artery removal technique, the results on the endoscopic harvesting method are not definitive.

More than 9 percent of people whose veins were removed with the newer endoscopic harvesting method died or suffered a heart attack in the following three years, versus fewer than 8 percent of those who had the traditional big incision.

More research is needed to confirm the results, but doctors probably should use the technique more sparingly or handle the vein more carefully when they do pull it out.

For more information please see: New England Journal of Medicine Article

Labels: bypass sugery, doctor, endoscopic, heart attack, new england

posted by Jessica at 10:03 AM

Drug Makers Agree to Pay $5.4 Million for a Cholesterol Drug Cover-Up

Drug makers, Merck & Co. and Schering-Plough Corporation, agreed yesterday to pay $5.4 million to settle civil claims that the companies covered up test results that cast doubt on the effectiveness of their two blockbuster cholesterol drugs, Vytorin and Zetia.

In 2006 a series of studies were done by the two companies that revealed Vytorin and Zetia were less effective in reducing plaque build-up. However, the companies failed to release their findings immediately, which consequently resulted in criticism from several attorney generals.

The companies settled with attorney generals from 35 states, including the District of Columbia and Wisconsin. Merck Co. and Schering- Plough both agreed to pay back the costs of the investigation, but they do not have to make other payments or admit liability.

Labels: cholesterol, Merck Co, million dollar, settlment, Vytorin, Zetia

posted by Chavon Williams at 8:29 AM

Wednesday, July 15, 2009

Day Care Camp Refused to Accept Swim Club Invitation to Return to Pool

The largely minority day care center that was banned from Valley Swim Club last week has refused an offer to return to the facility to swim for the summer. As reported last week, the swimming privileges for about 65 children from the Creative Steps Day Care Center were revoked after one visit to the club, on June 29. Some of the children, who are Hispanic and African American, said Caucasian club members made racists comments to them, asking why “black children” were there and raising concerns that “they might steal from us”.
The swim club extended an invitation for the day care to return; however, in a meeting held by Creative Step’s Director, Alethea Wright, parents stated that they did not want their children to return to Valley Swim Club’s facility.
Swim club director, John Duesler, released a statement late last week stating that safety and crowing, not racism, prompted the cancellation.
Attorneys for the day care center announced that they plan to file a lawsuit against the swim club within the next coming weeks. They also stated that they want swim club board members removed along with the club members who made the racist comments. “The children’s best interests are not being severed,” Carolyn Nichol, an attorney for the day care center stated. “Simple lip service does not amount to change.”

Labels: Creative Steps Day Care Center, lawsuit against swim club, swim club racism, Valley Swim Club

posted by Chavon Williams at 8:33 AM

FDA takes Steps to Fight Counterfeit Drugs

The U.S. Food and Drug Administration seeks to make it more difficult to pass off counterfeit drugs through the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs).

A PCID is a substance or combination of substances possessing a unique physical or chemical property used to identify a drug. In some cases, the PCID may be easily detected to determine if they have authentic products. In other cases, special analytical instruments may be necessary to identify whether the PCID is present.

Many of the potential PCID ingredients are already commonly used as food additives, colorants, or other types of inactive ingredients that are known to be safe.

To further minimize adverse effects, the FDA recommends using the lowest level of PCID that ensures identification of the product. The PCID should be a substance with no medicinal effect and placed within the dosage form so that it does not interact with the drug’s active ingredient.

The FDA invites comments on the draft guidance, available online and titled “Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting.”

For more information please see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm171632.htm

Labels: All Star Game, Counterfeit, drugs, FDA, July 15

posted by Jessica at 8:19 AM

Study Says Hormone Therapy Increases Risk of Ovarian Cancer

According to a study published in the Journal of the American Medicine Association, women who use hormone therapy after menopause may be at a higher risk of ovarian cancer, and the risk remains elevated for up to two years after women stop taking estrogen. What’s more, even a relatively short duration of hormone therapy, less than four years, is associated with a 30 to 40 percent higher risk of ovarian cancer in current users, researchers said.

Hormone therapy has been linked to health hazards in the past. Notably, part of a long- term government run study known as the Women’s Health Initiative was stopped early in 2002 because women who took hormones for many years had an increased risk of breast cancer, stroke, heart disease, and blood clots in their lungs and legs. Since then, the use of hormones, once offered to millions of older women to treat menopause symptoms and potentially protect against heart disease, has dropped dramatically. Breast cancer rates have also dropped, most likely because of decline long- term hormone use, experts say.

“Women currently taking hormones seem to reduce their risk of ovarian cancer by quitting hormone use,” says study author Linda Steinrud Morch of Rigshospitalet- Copenhagen University, in Denmark. “The risk warrants consideration when deciding whether to use hormone therapy, particularly if a woman has a special predisposition for ovarian cancer. She should consider not taking hormones.”

For more information see: http://www.cnn.com/2009/HEALTH/07/14/ovarian .cancer.hrt/index.html

Labels: blood clot, breast cancer, heart disease, Journal of American Medicine Association, menopause symptoms, ovarian cancer

posted by Chavon Williams at 7:56 AM

FDA Recalls Generic version of drug of Powerful Sedative

This drug is reportedly linked to Michael Jackson’s Death

Two tainted lots of a generic version of a drug reportedly taken by Michael Jackson have been recalled by the drug maker. Teva Pharmaceuticals has voluntarily recalled Propofol, the generic version of Diprovan, which is a powerful anesthetic and sedative.

However, no link has been established between the drug and the singer's death. Jackson died June 25 of cardiac arrest. The CDC is not involved in the investigation into Jackson's death.

The CDC issued a health advisory Monday, stating two lots of a generic version of the drug had tested positive for endotoxin, a contaminant.

There are 40 reported events of patients developing high fevers and muscle aches after being injected with the drug. All of the people who had taken propofol recovered; only one was hospitalized and that patient was quickly discharged.

At high doses, endotoxin can lower blood pressure and cause much more serious reactions. A decrease in blood pressure can cause problems with the heart, said Dr. Arjun Srinivasan, the chief investigator on the recall for the Centers for Disease Control and Prevention.

Teva Pharmaceuticals is working with the FDA to determine how the contamination occurred and is voluntarily recalling the affected lots.

According to Teva, about 57,000 100 ml vials were recalled. With regard to the Jackson investigation, spokeswoman Denise Bradley said, “I can say the DEA did contact us about a specific lot number, and that lot number is not from the two we are recalling."

The affected lots are 31305429B and 31305430B. Healthcare professionals are advised to immediately stop using these lots of propofol.

The Associated Press and the Los Angeles Times, citing unidentified sources, have reported that police found the drug Diprivan, a brand-name version of propofol, among Jackson's medicines.

The FDA requests reports of adverse events with propofol are made to MedWatch. These voluntary reports will help FDA gather additional information related to this problem and assess its public health impact.

The FDA can be contacted via:

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 800-FDA-0178
Phone: 800-FDA-1088

For more information please see: CNN's Reports on the Events or CDC Advisory Letter to Health Care Professionals

Labels: CDC, chills, diprovan, endotoxin, FDA, fever, Michael Jackson, Propofol, recall, Teva

posted by Jessica at 7:27 AM

FDA Announces Label Change for Certain Immunosuppressant Drugs

The FDA announced yesterday that is requiring a label change for certain immunosuppressant drugs. The FDA conducted an analysis of its Adverse Event Reporting System on MedWatch and discovered a link between BK virus-associated nephropathy and the use of certain immunosuppressant drugs. The required label change is to reflect that immunosuppressed patients are at an increased risk for opportunistic infections, such as activation of latent viral infections, including the BK virus-associated nephropathy. The drugs affected by the label change are used to protect against the rejection of organs when a patient undergoes an organ transplant. The occurrence of BK virus-associated nephropathy has been primarily observed in renal (kidney) transplant patients.

The immunosuppressant drugs affected by the required label change are:
Sirolimus (brand name Rapamune)
Cyclosporine (brand name Sandimmune, also generics are affected)
Cyclosporine (brand name Neroral, also generics are affected)
Mycophenolate mofetil (brand name Cellcept, also generics are affected)
Mycophenolic acid (brand name Myfortic)

BK virus-associated nephropathy can progress to renal allograft loss. Monitoring for this serious risk and early intervention by the health care provider is critical. The association of BK virus-associated nephropathy has previously been linked with another drug, tacrolimus (brand name Prograf). The label changes that the FDA announced for the above listed drugs have already been included on the label of Prograf. The FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation. The FDA is urging health care professionals and patients to continue to report adverse events from the use of immunosuppressant drugs to the FDA’s MedWatch Adverse Event Reporting System.

For more information, see the FDA’s MedWatch Safety Information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171828.htm

See the FDA Press Release at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171828.htm

See the Information for Healthcare Professionals at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm171654.htm

Labels: BK virus, BK virus-associated nephropathy, Cellcept, cyclosporine, FDA, immunosuppressant, mycophenolate, Myfortic, Neroral, Rapamune, renal transplant, Sandimmune, sirolimus

posted by Colleen at 6:59 AM

Monday, July 13, 2009

Eli Lilly Blood Thinner Approved, despite safety risks

The Food and Drug Administration approved a blood thinner from Eli Lilly, of Indianapolis, but the drug must have a black box warning of its risk of causing bleeding. The boxed warning is reserved for issues that can cause serious injury or death.

Lilly’s Effient is the first real competition to the blood thinner Plavix, which is made by Sanofi-Aventis and Bristol-Myers Squibb.

A Lilly study of more than 13,000 patients found that thought Effient prevented more heart attacks than Plavix, it caused more internal bleeding. Company studies showed 7 percent of patients taking Effient had nonfatal heart attacks, compared with 9.1 percent of patients taking Plavix. Despite lower rates of certain heart attacks, the actual rates of death for the drugs were similar.

The F.D.A. approval of Effient was 18 months long it weighed the drug’s benefits and risks.

Effient should not be taken by patients with a history of bleeding, stroke or who are undergoing an operation.

Like Plavix, Effient prevents blood platelets from sticking together and forming potentially dangerous clots. Effient is approved only for those undergoing angioplasty, a procedure in which an inflatable balloon is used to clear arteries clogged with plaque, which are often propped open with a stent.

For more information please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm171497.htm

Labels: angioplasty, approval, bleeding, blood thinner, Effient, FDA, heart attack, plavix

posted by Jessica at 12:19 PM

Veterans Affairs Facility Putting Patients at Risk for Overdose

Two years after Iraq war veteran, Justin Bailey, overdosed on medication at a Veterans Affairs facility, the problems blamed in his death have not been corrected at many of the VA’s residential treatment sites, a government study confirmed.

The VA’s inspector general ordered a review of all Veteran Affairs facilities as part of legislation passed to fix problems after the 2007 death of the 27-year-old in a Los Angeles residential facility. Bailey had surgeries for a groin injury he sustained during the first part of the Iraq war and was diagnosed with post-traumatic stress disorder. His father, Tony Bailey, later testified before Congress that the day before his son died, he was given five different prescriptions in doses covering, 14, 15 and 30 days. He said his son was known to abuse prescription medication and had used illegal drugs.

The inspector general’s review found that fewer than half of Veteran Affairs facilities visited had appropriate polices to screen patients. The review also stated that more than 10 percent of patients who were allowed to give themselves narcotics received more than a week’s supply.

The VA administration has said it will implement improvements, and will make sure to make the recommended changes.

For more information see: http://www.msnbc.msn.com/id/31850584/ns/health-health_care/

Labels: Congress, illegal drugs, Iraq, prescription medication, Veterans Affairs

posted by Chavon Williams at 11:08 AM

Mallinckrodt recalls One Lot of Sodium Chromate Injection

Covidien, a St. Louis based company, announced last week that its subsidiary Mallinckrodt Inc. is voluntary recalling one of its products, Sodium Chromate Injection # 370-9004 as a result of testing that has shown that the injection is not potent. The injection is used to determine a patient’s red blood cell volume and the life span of the patient’s red blood cells. Increased red blood cell volume is associated with a disease known as Polycythemia rubra vera, which is diagnosed by relying on various blood and other test results. A misdiagnosis or delayed diagnosis of Polycythemia can result in an increased risk of embolus or stroke.

Mallinckrodt has issued the recall to inform healthcare providers that the low potency of the Injection can lead to the potential of a false low reading of red blood cell volume which can lead to a misdiagnosis of Polycythemia. Customers who have product from the recalled lot in their possession should discontinue use immediately. Customers with questions about the recalled product, including returns, should contact Product Monitoring at 800-778-7898 (7:00 am to 5:00 pm CT).

For more information, see the FDA recall notice at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171396.htm

See the FDA Press Release:
http://www.fda.gov/Safety/Recalls/ucm171302.htm

Labels: Covidien, Mallinckrodt, Polycythemia rubra vera, red blood cells, Sodium Chromate Injection

posted by Colleen at 7:19 AM

Friday, July 10, 2009

Philadelphia Swim Club Accused of Racial Discrimination against Kids

When children from the Creative Steps Day Care arrived at the Valley Swim Club in Huntingdon Valley, Pennsylvania on June 29, they received a less than welcomed response from club members. Directors of the Creative Steps Day Care reported Thursday that members of the private swim club made racist comments about the center’s children, and the club then cancelled their swimming privileges.

Creative Steps Day care had contracted with the

Valley Swim Club to use the club’s swimming pool once a week. However, during their first visit some of the children said they heard club members asking why African American children were there. One of the boys told the Philadelphia Inquirer that a woman at the club said she feared the children “might do something” to her child. Days later, the day care center’s $ 1,950 check was returned without explanation, said Alethea Wright, a director for the center.

The stepfather of one of the children filed a complaint against the club with the Pennsylvania Human Relations Commission. As for the Valley Swim Club’s part in the matter, they are disputing the allegations of racism. They responded to these allegations by posting a statement on their website, “We had originally agreed to invite the camps to our facility, knowing full well that the children from the camps were from multi-ethnic backgrounds. Unfortunately, we quickly learned that we underestimated the capacity of our facilities and realized that we could not accommodate the number of children from these camps. All the funds were returned to the camps and we will re-evaluate the issue at a later date to determine whether it can be feasible in the future.”

A small group of protestors gathered in front of the club Thursday after the club’s President, John Duesler stated to two Philadelphia television stations that the children had changed “the complexion” and “atmosphere” of the club.

Civil Rights Activists in the Pennsylvania area have agreed to investigate these allegations to the fullest.

For more information see: http://www.cnn.com/2009/US/07/09/philly.pool/index.html?eref=rss_topstories

Labels: Day care center, Philadelphia, swim club, swim club racist, Valley Swim Club

posted by Chavon Williams at 7:59 AM

Class I Recall for Respironics' BiPAP Focus Non-Invasive Ventilator System

The FDA yesterday elevated the recall on the BiPAP Focus Non-Invasive Ventilator System to a Class I status. The ventilator, manufactured by Respironics California, Inc., is being recalled for power supply failures. The device is used by healthcare professionals to treat adult patients who have advanced lung disease or difficulty breathing. In the ventilator, a wiring problem may cause a power surge which can exceed the power supply capacity, causing the power supply to lose power and the ventilator to not function properly.

Class I recalls are the most serious type of recall and involve products that the use of can cause serious injury or death. The particular product being recalled is model number PCM120PS18-2315P. Customers or health care providers can contact Respironics Customer Service at 1-877-387-3377.

For more information, see the MedWatch safety information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171242.htm

See the Recall Notice from the FDA at:
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm171194.htm

Labels: Class 1 recall, FDA, Lung disease, Respironics, Ventilator

posted by Colleen at 7:35 AM

Smoke Detector Recalled for Possible Failure to Alarm

About 94,000 Kidde dual sensor smoke alarms, model PI2000, are recalled for possible failure to warn consumers of a fire.

There have been at least two reports of smoke alarm malfunctions involving electrostatic discharge during installation. Though no injuries have been reported, a smoke alarm failure poses serious risk of personal and property damages.

Walter Kidde Portable Equipment of Mebane, N.C. imports Kidde PI200 from China. The recall includes the date codes 2008 Aug. 01 through 2009 May 04. The products were sold nationwide at retail, department, and hardware stores as well as through electrical distributors between August 2008 and May 2009.

For more information please visit: Kidde.com or U.S. Consumer Product Safety Commission.

Labels: China, Fire, Fire Alarms, Kidde, kidde PI200, Mebane

posted by Jessica at 7:05 AM

Thursday, July 9, 2009

Government Officials Pushing for Stricter Labeling on Bottled Water

Both the Government Accountability Office and The Environmental Working Group, a nonprofit research and advocacy organization, recommended in reports released on Wednesday that bottled water be labeled with the same level of information municipal water providers must disclose.

As a food product, bottled water is regulated by the FDA and required to show nutrition information and ingredients on its labels. Municipal water is under the control of the Environmental Protection Agency. According to the Government Accountability Office, the two agencies have similar standards for water quality, but the FDA has less authority to enforce these standards.

Consequently, researchers urge Americans to make bottled water a “distant second choice” as opposed to filtered tap water because researchers claim there isn’t enough information about bottled water. The Environmental Working Group recommends that Americans purify their tap water by purchasing a commercial filter.

For additional information see: http://www.msnbc.msn.com/id/31802507/ns/health-food_safety/

Labels: bottled water, EPA, FDA, filter, raven, tap water

posted by Chavon Williams at 10:48 AM

Nine Companies Penalized for Excessive Lead Paint on Children’s Toys

Nine children’s product manufacturers, importers, and sellers have agreed to pay a combined total of more than $500,000 in civil penalties for violating the federal lead paint ban, according to the Consumer Product Safety Commission.

These nine firms’ products were recalled in 2007 and 2008, and include items such as toys, children’s metal jewelry, children’s pens, metal water bottles, pencil pouches, sunglasses, and children’s Halloween pails and baskets.

Tests revealed that paint or surface coatings on these children’s products contained lead in excess 0.06 percent, by weight. One firm’s testing revealed that its products contained surface coatings with nearly 60 percent lead. In 1978, a federal ban was put in place that prohibited toys and other children’s articles from having more than 0.06 percent lead (by weight) in paints or surface coatings.

Lead can be toxic if ingested by young children. Exposure to lead can cause brain and nervous system damage, behavioral and learning problems, slowed growth, hearing problems, headaches, mental and physical retardation, and behavioral and other health problems in children and unborn children. Even at very low levels, lead is harmful to children’s health. But at elevated blood lead levels, children experience neurological problems, anemia, lower IQ scores, and shortened attention spans.

CPSC has ordered the following firms to pay civil penalties to the federal government:

Cardinal Distributing Co. Inc., of Baltimore, Maryland: $100,000
Dollar General Corp., of Goodlettsville, Tennessee: $100,000
Family Dollar Stores Inc., of Matthews, North Carolina: $75,000
Hobby Lobby Stores Inc., of Oklahoma City, Oklahoma: $50,000
First Learning Company Ltd., of Hong Kong: $50,000
Michaels Stores Inc., of Irving, Texas: $45,000
A&A Global Industries Inc., of Cockeysville, Maryland: $40,000
Raymond Geddes & Co, of Baltimore, Maryland: $40,000
Downeast Concepts Inc., of Yarmouth, Maine: $30,000

In agreeing to settle the matters, the firms deny CPSC’s allegations that they knowingly violated the law.

For photos of all affected projects please visit the U.S. Consumer Product Safety Commission’s website: http://www.cpsc.gov/cpscpub/prerel/prhtml09/09264.html

Labels: Cardinal Distribuiting, Dollar General, fines, Hobby Lobby, lead, paint, settlement

posted by Jessica at 9:50 AM

ACLU Files Suit Against Maplewood Challenging the Town's Funeral Protest Ban as Unconstitutional

The American Civil Liberties Union (ACLU) brought suit against the town of Maplewood yesterday challenging the town’s ban on funeral protesting as unconstitutional. The ACLU brought the suit on behalf of the controversial Kansas-based Westboro Baptist Church. The Church’s founder Fred Phelps believes that America is being punished with the death of soldiers for its tolerance of homosexuality. Church members first began protesting at the funerals of homosexuals, but can also be found protesting the funerals of soldiers and carrying signs that say things such as “Thank God for Dead Soldiers.”

The suit was filed in U.S. District Court in St. Louis, but is part of a larger effort by the ACLU to go after state and local laws banning funeral protesting, says Tony Rothert, the legal director of the ACLU of Eastern Missouri. The Westboro Baptist Church has already made some progress in challenging a state of Missouri law that banned funeral protests. A suit was filed to block the enforcement of the law while the constitutional challenge was tried, which was initially turned down by the District Court but was reversed by the 8th Circuit Court of Appeals. Maplewood’s law is stricter than the state law, requiring a wider protest exclusion zone that lasts for a longer period of time. The mayor of Maplewood and a lawyer that represents Maplewood would not comment on the suit.

For more information, see the St. Louis Post-Dispatch article at:
http://www.stltoday.com/stltoday/news/stories.nsf/stlouiscitycounty/story/1E6E79B4D3D3166D862575ED00017B60?OpenDocument#tp_newCommentAnchor

Labels: ACLU, funeral, homosexuality, Phelps, protest, soldiers, Westboro Baptist Church

posted by Colleen at 9:04 AM

Arthroscopic Shavers: Ongoing Safety Review

FDA informed healthcare professionals that pieces of tissue have remained within arthroscopic shavers even after the manufacturer’s cleaning instructions were properly followed. Arthoscopic shavers are devices used in orthopedic surgical procedures. Retained tissue can compromise the entire sterilization process. FDA finds this tissue retention to be serious and is actively working with the device’s manufacturers to understand its potential public health impact. FDA encourages facilities to evaluate the adequacy of their cleaning procedures.

If tissue is found after cleaning, the FDA requests reports be made to MedWatch. These voluntary reports will help FDA gather additional information related to this problem and assess its public health impact.

The FDA can be contacted via:

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 800-FDA-0178
Phone: 800-FDA-1088

For more information please see: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170730.htm

posted by Jessica at 6:32 AM

Wednesday, July 8, 2009

FDA Mandates that Darvocet Must Carry Stronger Warning Labels

The FDA has decided to let painkillers Darvocet, Darvon and their genetic versions stay on the market but has ordered stronger warning against deadly overdoses. Darvocet, which is known generically as propxyphene, is widely used in the U.S. even though doctors consider it to be a “weak pain reliever”.

The group Public Citizen petitioned the FDA to ban the drug in the United States, saying that the small benefit didn’t justify a risk that was adding up to several hundred deaths a year. Britain banned the drugs several years ago citing a trail of suicides and accidental overdoses.
However, in the United States the FDA only ordered that a stern box warning be placed on the drug’s label, and that patients soon start receiving a special pamphlet with every bottle that stresses the risk of taking too much.
Public Citizen is considering whether to appeal the FDA’s decision regarding Darvocet and Darvon.

“This is a reckless decision on the part of the FDA unless they believe Americans are resistant to the death- causing properties of this drug in a way that Europeans and the people in the U.K aren’t,” said Public Citizen’s Dr. Sidney Wolfe. “You’ve got a drug which has a barely perceptible benefit and a very clear risk.”

For more information see: http://www.msnbc.msn.com/id/31785225/ns/health-more_health_news/

Labels: Darvocet, Darvon, FDA, painkillers, Public Citizen

posted by Chavon Williams at 8:07 AM

EEOC Files Lawsuit Against St. Louis Construction Company

A lawsuit has just been filed against A&A Contracting, a St. Louis based construction company, for firing a worker with a history of health problems. The lawsuit, filed by the Equal Employment Opportunity Commission (EEOC), alleges that the company fired Rickie Wells because he had a history of liver and kidney problems as well as being diagnosed with cancer. At the time that Mr. Wells was terminated, he was in good health and was cleared to work by his doctor.

The EEOC says A&A Contracting became aware of Wells' health history when he applied for the company's health insurance coverage. Federal law bars discrimination against employees and applicants who are disabled or have a record of disability. The lawsuit seeks back pay for Wells and damages.

For more information, see the article from the St. Louis Post-Dispatch at:
http://www.stltoday.com/stltoday/news/stories.nsf/stlouiscitycounty/story/D648607E64C713EF862575ED003E5D6A?OpenDocument

Labels: AA Contracting, cancer, EEOC, kidney, St. louis

posted by Colleen at 7:12 AM

Tuesday, July 7, 2009

Heart Attack Survivors Enrolled in Study Not Told of Dangers

A federal investigation has revealed that heart attack survivors enrolled in a study using Chelation, which involves periodic infusions of the drug Disodium ETD, were not told enough about potential dangers from the drug, including death.

Findings from the investigation were revealed this week by the U.S. Office for Human Research Protections in a letter to the three medical centers leading the study, Mount Sinai Medical Center in Miami Beach, Florida; the University of Miami; and Duke University Medical Center in Durham, North Carolina.

The probe found that several doctors doing the study had been accused of poor practices by state medical boards or involved in insurance fruad, and that at least three are convicted felons. Federal officials recommended corrective steps to researchers, but have allowed to study to go on while the probe continues. This decision has angered critics. Arthur Caplan, Chief of Bioethics at the University of Pennsylvania stated, “This study should not be going on. It is incredibly unethical to subject anyone to these risks.”

Disodium ETD carries a risk of kidney failure, bone marrow problems, shock, low blood pressure, convulsions, heart rhythm problems, allergic reactions and breath troubles, reported the American Heart Association.

For additional information see: http://www.msnbc.msn.com/id/31715589/ns/health-heart_health/

Labels: Duke University, heart attack, heart disease, insurance fraud, medical boards, Mount Sinai Medical Center

posted by Chavon Williams at 11:46 AM

Walt Disney World monorail crash kills employee

Two monorail trains collided early Sunday morning at 2 a.m. in the Magic Kingdom section of Walt Disney World, killing one train's operator. The other train operator was uninjured but emotionally shaken.

Disney's senior spokesman Michael Griffin identified the killed driver as 21-year-old Austin Wuennenberg. Wuennenberg was a student at Stetson University.

Disney said it was the first fatal crash in the monorail's 38-year history in the park. Disney has not released any details of the accident. The cause of the accident is unknown. Orange County Sheriff and U.S. Occupational Safety and Health Administration officials are investigating. The monorail system is closed pending the investigation of the accident.

Disney spokeswoman Zoraya Suarez said the park had boosted other forms of transport — such as ferries, boats and buses — for visitors Sunday.

In a statement, Walt Disney World offered its condolences to the employee's family.

For more information, please see: http://www.cnn.com/2009/US/07/05/u.s.disney.monorail/

Labels: Austin Wuennenberg, david carradine death photo thai, Disney World, family vacation, monorail, Orlando, Stetson University

posted by Jessica at 10:53 AM

FDA Approves New Maintenance Therapy Drug to Treat Advanced Lung Cancer

The FDA approved Alimta yesterday, the first maintenance therapy drug available to treat advanced lung cancer. Patients are often treated with maintenance therapy to prevent the cancer from spreading once the tumor itself is shrunk or has been responsive to chemotherapy. Alimta disrupts the production of B-vitamin folate in certain cells, a necessary ingredient for cell replication.

When asked on his thoughts about Alimta, Dr. Richard Pazdur, MD, and director of the FDA’s Drug Evaluation and Research Office of Oncology Drug Products stated, “This drug represents a new approach in the treatment of advanced non-small cell lung cancer. Typically, patients whose tumors respond to chemotherapy do not receive further treatment after four-to-six chemotherapy cycles. This study demonstrates an advantage in overall survival in certain patients who received Alimta for maintenance therapy.”

Alimta, manufactured by Eli Lily & Co. of Indianapolis, initially was approved in 2004 for the treatment of patients with mesothelioma, a cancer frequently related to asbestos exposure. The drug was later approved for the treatment of patients with non-small cell lung cancer whose disease worsened on prior chemotherapy drugs and also as an initial therapy for advanced non-small cell lung cancer.

For more information, see the FDA News Release at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170515.htm

Labels: Alimta, cancer, chemotherapy, FDA, maintenance therapy, Mesothelioma

posted by Colleen at 10:38 AM

Monday, July 6, 2009

FDA warns of Knife Blades found in Hardcore Energize Bullet and New Whey Liquid Products

The FDA warns consumers not to buy or use Hardcore Energize Bullet or New Whey liquid products sold in test tube-like vials because of suspected product tampering. Both products are recalled.

A utility knife blade was found in a vial of Hardcore Energize Bullet drink, manufactured in the United States and sold in Canada. A second blade was found in one vial of New Whey liquid products, manufactured and sold in the United States. There are no reported injuries.

Both Hardcore Energize Bullet and New Whey liquid products are manufactured by Protica Inc., of Whitehall, Pa.

Hardcore Energize Bullet liquid products are recalled by distributor iSatori Technologies of Golden, Colo. The liquid is packaged in 2.9 ounce clear vials. The flavors affected are: Blue Rage and Black Rush.

The affected lots for the Blue Rage liquid product are: 1961, 1962, and 1794. The affected lot for the Black Rush liquid product is 1963.

New Whey liquid products are recalled by distributor IDS of Oviedo, Fla. The liquid is packaged in 2.9 ounce clear vials. The flavors affected are New Whey Fruit Punch 25g and New Whey Blue Raspberry 42g.

The affected lot for the New Whey Fruit Punch liquid product is 1960. The affected lot for the New Whey Blue Raspberry liquid product is 1944.

The FDA encourages consumers and healthcare professionals to report adverse events and product quality issues to the FDA.

The FDA can be contacted via:

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 800-FDA-0178
Phone: 800-FDA-1088

For more information please see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170500.htm

Labels: engery drink, FDA, hardcore, hardcore energize bullet, knife blade, new whey, recall

posted by Jessica at 7:05 AM

Former Hospital Worker Infected with Hepatits C Caught Swapping Clean Needles with Used Ones

A former worker at Rose Medical Center in Denver, Colorado, may have infected hundreds with the Hepatitis C virus. The worker, Kristen Diane Parker, was swiping injections of fentanyl from the hospital and injecting herself with the drug in the bathroom. Parker would then fill the used, unclean syringes with saline solution and put them back where she found them so that no one would know.

Parker knew that she had Hepatitis C and had previously been counseled on how to limit her exposure to patients. Parker believes she contracted the virus through using heroin and sharing dirty needles.

Parker quit when she was found in an operating room when she was not supposed to be there. She subsequently tested positive for fentanyl and hospital officials contacted the FDA. So far, 9 patients who had surgery at Rose Medical Center during that time have tested positive for Hepatitis C and the hospital is contacting 4,700 other patients who also had surgery there at that time.

Parker is currently in federal custody and is facing three drug related charges. If she is found to have done serious harm to one of the patients, she could face up to 20 years in prison. If any of the patients die as a result of her behavior, she could face life in prison.

For more information, see the article from the CNN website at:
http://www.cnn.com/2009/CRIME/07/03/hospital.employee.arrest/index.html?eref=rss_health

Labels: Fentanyl, Hepatits C, hospital, injections

posted by Colleen at 7:04 AM

Thursday, July 2, 2009

FDA is Requiring Chantix and Zyban to Carry Depression Warning

The FDA is requiring two smoking cessation drugs, Chantix and Zyban, to carry a safety warning regarding side effects including depression and suicidal thoughts. The new requirement, which is called a “Black Box” warning, is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drugs.

The FDA is also requiring an additional study on Chantix and Zyban to determine the extent of the side effect. Pfizer Inc., which makes Chantix, said it is still discussing the potential study design with the FDA. According to Pfizer, Inc. officials, the study could include patients with and without psychiatric conditions to determine the true incidence rate of psychological side effects.

Pfizer has previously updated it labeling after an FDA investigation into potential side effects in 2007. That investigation was sparked by several reports of psychiatric problems in patients. However, despite the new, stricter warnings, the FDA said consumers and doctors still have to weight the benefit versus the risks when taking these drugs.

For more information see: http://www.msnbc.msn.com/id/31685329/ns/health-addictions/

Labels: Chantix, Family Smoking Prevention and Tobacco Control Act, Pfizer, Zyban

posted by Chavon Williams at 11:32 AM

FDA Speaks Up About Insulin and Cancer Risk

FDA acknowledges four recent studies that observed the use of the insulin, Lantus and possible risk for cancer. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. See http://www.diabetologia-journal.org/cancer.html.

Currently, the FDA recommends that patients consult their doctor before stopping their insulin therapy. Patients should not stop their therapy on their own. Uncontrolled blood sugar levels can pose both immediate and long-term serious adverse effects.

Similar to human insulin, Lantus is used to control blood sugar in people with Type 1 and Type 2 diabetes. Lantus is a long-acting insulin that is only approved for once-a-day dosage delivered by under the skin injections.

In all four studies, the length of patient follow-up was shorter than what is necessary to evaluate for cancer risk from drug exposure. Further, the studies were inconsistent within themselves and with each other, which raises the question if there really is an association between Lantus and cancer. Additionally, differences in patient characteristics in the various treatment groups may have contributed to a finding of increased cancer risk.

Nonetheless, FDA is reviewing the safety data for Lantus to better understand the risk, if any, for cancer associated with use of Lantus. FDA is also communicating with Lantus if any additional studies are needed to evaluate the safety and efficacy of Latus.

FDA requests that any adverse events associated with Lantus be reported to their MedWatch program.

he FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders

Labels: cancer, diabetes, FDA, insulin, Lantus

posted by Jessica at 7:44 AM

U.S. Troops are Pulled Out of Iraqi Cities

United States troops have been pulled out of Iraqi cities. Not a single American soldier could be spotted in Baghdad yesterday. As part of a security deal struck by President Bush, all soldiers will be completely out of Iraq by 2011. As of now there are still about 131,000 troops in Iraq, but they aren’t fighting in the urban areas anymore. Instead, the troops are busy securing the borders, keeping insurgents at bay in rural areas, and training Iraqi security forces.

The violence in Iraq has steadily decreased since 2007, leading President Obama to announce that he will accelerate the troop pull out, with a complete end to U.S. military combat role by September 2010. Iraqi police and the Iraqi army are now left alone to protect the cities, manning the checkpoints and guarding trouble areas with tanks. Experts question whether Iraqi security is ready to handle any type of insurgency, and if the violence levels begin to rise again, America will have to rethink their exit strategy. However, many are hopeful for a successful withdrawal. For example, Gen. Ray Odierno, the top U.S. commander in Iraq, said Tuesday he was hopeful, in part because Iraqis have embraced the U.S. urban withdrawal as a confidence booster."They're not ready for us to go yet, but they are ready for us to allow them to attempt to exercise their security responsibilities, and to me that's very encouraging," Odierno said.

For more information, see the article in the St. Louis Post-Dispatch at:
http://www.stltoday.com/stltoday/news/stories.nsf/world/story/2E8617CE1562A83D862575E60011020C?OpenDocument

Labels: army, Bush, Iraq, Iraq war, Obama, U.S. military

posted by Colleen at 7:19 AM

Missouri Woman Convicted of Cyber Bullying to be Sentenced Today

Lori Drew, 49, the woman from Missouri that was convicted of cyber bullying, is set to be sentenced today in U.S. District Court. Drew was convicted in November 2008 of illegally accessing a protected computer, the California-based MySpace. Drew began to come under suspicion after Megan Meier, a 13 year old neighbor of Drew’s, committed suicide. It later came out that Meier was a rival of Drew’s daughter and that Drew created a profile for a nonexistent teenage boy on MySpace that initially befriended Meier and later turned on her. Meier committed suicide soon after receiving a message from the Drew-created boy that told Meier that “the world would be a better place without you.”

Drew was not held culpable for Meier’s death, but instead was convicted of violating the terms and agreements of MySpace to a criminal degree. The prosecution is asking for the maximum fine and sentence which is $5,000 and 3 years in prison. The defense argues that Drew did not read the terms and conditions, nor did she intentionally violate them and therefore they are asking for probation only and no fine. The sentencing is set in California today at 1:00 p.m. St. Louis time.

For more information, see the article from the St. Louis Post-Dispatch at:
http://www.stltoday.com/stltoday/news/stories.nsf/laworder/story/9EE26E82036653B9862575E7001EC3D9?OpenDocument

Labels: crime, Cyberbullying, Lori Drew, MySpace, sentencing, suicide

posted by Colleen at 7:11 AM

Wednesday, July 1, 2009

Johnson & Johnson wins $1.67 billion in Suit

Abbott Laboratories is liable for $1.67 billion in a patent infringement suit against Johnson & Johnson. Abbott was found to have infringed on the patent for Remicade when developing its own best-selling drug, Humira. Remicade was developed by Centocor, a unit of Johnson and Johnson. The patent infringement suit was filed against Abbott in April 2007.

Humira and Remicade are anti-TNF drugs, which block tumor necrosis factor proteins in the blood. Excess TNF can cause inflammation, which leads to many of the symptoms suffered by those with autoimmune disorders like rheumatoid arthritis.

“We are particularly gratified that the jury recognized our valuable intellectual property, finding our patent both valid and infringed,” Kim Taylor, president of Centocor Ortho Biotech. Abbott had $4.5 billion in Humira sales in 2008.

Abbott will appeal the decision. The company contends that Humira was the first fully human anti-TNF antibody medicine. Remicade is partly made from mouse DNA. J&J acknowledged at trial that it did not start working on a fully-human antibody until 1997 – two years after Abbott discovered Humira and one year after Abbott filed its patent applications for Humira.

For more information please see: http://www.nytimes.com/2009/06/30/business/30drug.html?partner=rss&emc=rss

Labels: Abbott, humira, Johnson and Johnson, joint pain, remicade, rhematoid arthritis

posted by Jessica at 11:09 AM

Off- Label Use of Proteins in Neck Surgery Poses 50 % Increase of Complications

A bone growth protein, when used in spinal fusion surgeries for neck pain, has been linked to serious complications. Safety questions arose last year about the protein product, BMP, when used in fusion surgeries in the neck region, a use not approved by federal regulators.

A study recently published in The Journal of the American Medical Association confirms previous concerns about the use of the protein in neck surgeries. Medtronic and Stryker sell these bioengineered proteins, which are not federally approved for neck procedures. Minneapolis-based Medtronic sells Infuse, and Kalamazoo, Mich.-based Stryker sells OP-1 Putty.

These bioengineered proteins, which mimic natural substances that promote bone growth, were first approved in 2002 by the Food and Drug Administration but only for use in spinal fusions to alleviate lower back pain. Since 2002, doctors used BMP in 17,623 spinal fusions in 2006, nearly 1 in 4 cases.

Smaller studies have shown BMP promotes better healing of the bone and fewer repeat surgeries to fix failed spinal fusions. The product also makes it unnecessary to surgically harvest the patient's own bone from the shin or hip for a graft.

The study found that patients who had received the bioengineered proteins during spinal fusions for lower or middle back pain did not have increased complications when compared with those who did not get the product. But complications rates while patients were still in the hospital were 50 percent higher for cervical fusions procedures, researchers reported.

Last year alone the FDA received 38 reports of complications when the treatment was used in the neck region of the spine. Patients suffered complication such as swelling after surgery, which caused problems with breathing and swallowing. These reports prompted the FDA to issue an alert to health care providers of the complications.

Both companies are under investigation by both federal and state entities for off-label promotion. While doctors can independently choose to use a product for non-FDA approved purposes, companies may promote their products only for federally approved uses.

Medtronic added a label warning about neck complications in 2005. Stryker stated its product should only be used for approved purposes.

For more information please see: http://www.nytimes.com/2009/07/01/health/01spine.html?partner=rss&emc=rss

Labels: bone growth, breathing, Medtronic, neck pain, Stryker

posted by Jessica at 11:01 AM

Antibiotics May Boost Risk for Recurrent Ear Infection in Children

In a study released by the British Medical Journal, researchers found that repeated use of antibiotics to treat acute ear infections in young children increases the risk of recurrent ear infections by 20 percent.

The study included 168 children, 6 months to 2 years old, who were given antibiotics to treat an ear infection. Researchers found that 63 percent of the children who were given the antibiotic amoxicillin experienced a recurrent ear infection within three years, compared with 43 percent of children given a placebo at the time of their initial ear infection. However, the study also found that 30 percent of children in the placebo group had ear, nose, and throat surgery after their initial infection, compared with 21 percent in the amoxicillin group.

According to researchers, the higher recurrence rate among children who took amoxicillin could be due to a weakening of their body’s natural immune response as a result of taking an antibiotic at the initial stage of infection. Antibiotic use in such cases may cause an “unfavorable shift” toward the growth of resistant bacteria. Researchers say that antibiotics may reduce the length and severity of the initial ear infection, but may also result in a higher number of recurrent infections and antibiotic resistance.

For more information see: http://drugs.com/new/antibiotics-may-boost-risk-recurrent-ear-infection-18591.html

Labels: amoxicillin, antibiotics, babies, British Medical Journal, children, ear infection

posted by Chavon Williams at 10:08 AM

Previous Posts

Archives

Friday, July 31, 2009

U.S. Supreme Court Decision May Impact Drug, DUI Cases

Updated Safety Information for Colchicine

Mosquitoes used to deliver malaria ‘vaccine’

Thursday, July 30, 2009

FDA Advises Consumers Not to Use Body-Building Supplements that Contain Steroids

Wednesday, July 29, 2009

FDA Deems Mercury Level in Fillings Safe

Research Shows that Tanning Beds can be as Deadly as Arsenic

Tuesday, July 28, 2009

New FTC Rule Requires Doctors and Hospital to Check IDs

Blue Food Dye Linked to Reduced Severity of Spinal Injuries

Stevens-Johnson Syndrome Caused by Several Different Drugs

Should Hospitals Have to Offer Long Term Care to Indigent Non-documented Immigrants?

Monday, July 27, 2009

The Birth Control Pill may be Less Effective in Obese Women

Chemical used in Hospital Plastic Tubing and Feeding Bags Linked to Increased Risk of Liver Problems in Premature Babies

Agent Orange linked to serious heart disease

Complications from Transvaginal Placement of Surgical Mesh Patches Still Being Reported to FDA

Sunday, July 26, 2009

Several Brands of Baby Cribs Recalled Due to Entrapment and Falls

Saturday, July 25, 2009

ST. Louis Based SportsPlay Playground Equipment Recalled for Dangerous Lead Levels

Friday, July 24, 2009

iPod Warning: Your Device May Catch on Fire

Airman Losses Legs after Botched Surgery

Schlichter, Bogard & Denton Files Yasmin/Yaz Lawsuit

St. Louis Based Doe Run Co. Being Investigated by Missouri Attorney General for Environmental Cleanup Efforts

Denture Cream Users Developing Neurologic Disorders

The faster you walk, the longer you live

Thursday, July 23, 2009

FDA Warns Against the Use of E-Cigarettes

Reglan® and Drugs Containing Metoclopramide a Major Cause of Tardive Dyskinesia

Wednesday, July 22, 2009

New Lupus Drug may have Passed Key Test

Radon Found in Homes May Cause Lung Cancer Risk

Baxter Warned to Cease Making False Claims About the Efficacy of TISSEEL

Clayton Based Brown Shoe Co. Recalls Certain Children's Shoes Due to Choking Hazard

Tuesday, July 21, 2009

Beach Sand Can Carry Nasty Diseases

FDA Approves the Seasonal Flu Vaccine

Certain Gel-Filled Teethers are Recalled

Monday, July 20, 2009

Government Officials May Lift HIV Travel Ban

Friday, July 17, 2009

FDA Reviews Safety of Asthma Drug Xolair

FDA Reviews Safety of Asthma Drug Xolair

Thursday, July 16, 2009

Popular heart bypass technique may pose risk

Drug Makers Agree to Pay $5.4 Million for a Cholesterol Drug Cover-Up

Wednesday, July 15, 2009

Day Care Camp Refused to Accept Swim Club Invitation to Return to Pool

FDA takes Steps to Fight Counterfeit Drugs

Study Says Hormone Therapy Increases Risk of Ovarian Cancer

FDA Recalls Generic version of drug of Powerful Sedative

This drug is reportedly linked to Michael Jackson’s Death

FDA Announces Label Change for Certain Immunosuppressant Drugs

Monday, July 13, 2009

Eli Lilly Blood Thinner Approved, despite safety risks

Veterans Affairs Facility Putting Patients at Risk for Overdose

Mallinckrodt recalls One Lot of Sodium Chromate Injection

Friday, July 10, 2009

Philadelphia Swim Club Accused of Racial Discrimination against Kids

Class I Recall for Respironics' BiPAP Focus Non-Invasive Ventilator System

Smoke Detector Recalled for Possible Failure to Alarm

Thursday, July 9, 2009

Government Officials Pushing for Stricter Labeling on Bottled Water

Nine Companies Penalized for Excessive Lead Paint on Children’s Toys

ACLU Files Suit Against Maplewood Challenging the Town's Funeral Protest Ban as Unconstitutional

Arthroscopic Shavers: Ongoing Safety Review

Wednesday, July 8, 2009

FDA Mandates that Darvocet Must Carry Stronger Warning Labels

EEOC Files Lawsuit Against St. Louis Construction Company

Tuesday, July 7, 2009

Heart Attack Survivors Enrolled in Study Not Told of Dangers

Walt Disney World monorail crash kills employee

FDA Approves New Maintenance Therapy Drug to Treat Advanced Lung Cancer

Monday, July 6, 2009