Beginning yesterday, the FDA gathered more than 35 experts in Maryland to discuss their options of how to prevent overdoses of over-the-counter acetaminophen. Acetaminophen is the pain and fever reducing active ingredient in drugs such as Tylenol and Excedrin. Acetaminophen overdose is the leading cause of liver failure in the United States. We reported in May that the FDA was going to require acetaminophen to have stronger labels. The two day meeting that the FDA began yesterday was to discuss all of the alternatives in order to cut back on overdoses, including stronger warnings or pulling products from the shelve all together.

The drugs that could be pulled off shelves are combination medications, such as Procter & Gamble's NyQuil or Novartis' Theraflu, which combine acetaminophen with other ingredients that treat cough and runny nose. The FDA says patients often pair them with a pure acetaminophen medication, like Tylenol, exposing themselves to unsafe levels of the drug. Manufacturers of the drugs argue that the FDA is overemphasizing the dangers of acetaminophen. Only 10% of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association. The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Endo Pharmaceuticals Holdings Corp.'s Percocet, which combines oxycodone and acetaminophen.

Manufacturers could lose hundreds of millions of dollars in sales if combination drugs are pulled from the market. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80% of the market comprised of over-the-counter products. Manufacturers of the drugs also warned panelists that any new restrictions on acetaminophen would force patients to switch to nonsteroidal anti-inflammatory drugs (NSAIDS), which carry risks of gastrointestinal bleeding and sometimes fatal kidney injury. In response, the FDA has stated that its intent is only to reduce liver injury, not to decrease acetaminophen use or encourage the use of NSAIDS.

For more information, see the St. Louis Post-Dispatch article at:
http://www.stltoday.com/stltoday/news/stories.nsf/sciencemedicine/story/4CDAC39AECC98D31862575E50017457A?OpenDocument

Labels: Acetaminophen, Excedrin, FDA, liver failure, NSAIDS, Tylenol

Labels: doctors, prostate, radiation, University of Pennsylvania, VA Medical Center

A new method of attacking cancer cells, developed by researchers in Australia, has proved surprisingly effective in animal tests.The method is intended to sidestep two major drawbacks of standard chemotherapy: the treatment's lack of specificity and the fact that cancer cells often develop resistance to treatment.

The new method, called EnGeneIC, uses “minicells” to deliver a variety of agents to tumor cells, including both anti-cancer toxins and mechanisms for suppressing the genes that make tumors resistant to toxins.The “minicells” are generated from mutant bacteria which, each time they divide, pinch off small bubbles of cell membrane. The “minicells” can be loaded with chemicals and coated with antibodies that direct them toward tumor cells.No tumor cell, so far as is known, produces a specific surface molecule for toxins to act on. But 80 percent of solid tumors have their cell surfaces studded with extra-large amounts of the receptor for a particular hormone, known as epidermal growth factor.The “minicells” can be coated with an antibody that recognizes the receptor for epidermal growth factor, so they are more likely to attach themselves to tumors than to the normal cells of the body. The tumor cells engulf and destroy the “minicells”, a standard defense against bacteria, and in doing so are exposed to whatever cargo the “minicells” carry.

In one surprisingly effective test of the method, reported online Sunday in Nature Biotechnology, mice were implanted with a human uterine tumor that was highly aggressive and resistant to many drugs. All of the treated animals were free of tumor cells after 70 days of treatment; the untreated mice were dead after a month.

Dr. Robert M. Hoffman, of the University of California, San Diego, said that the “minicells” were "good strategy and good science" but that the researchers had implanted the human tumors under the mice's skin, a position from which they do not usually spread through the body. So the experiments do not answer the question of whether “minicells” can attack metastasized cancer, he said.

For more information, see the article in the St. Louis Post-Dispatch at:
http://www.stltoday.com/stltoday/news/stories.nsf/nation/story/06651E9B82F1DE8C862575E400075F53?OpenDocument

Labels: animal, cancer, chemotherapy, ENGENEIC, minicells, tumor

Roche Holding AG, one of biggest makers of cancer drugs, pulled its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease. Roche notified the FDA today that it would be withdrawing Accutane after a reevaluation of the product showed it faced serious challenges from generic competitors, company officials stated.

About 13 million people have used Accutane since it went on the market in 1982. The medication was Roche’s second-biggest selling drug before the patent expired in 2002 and rivals started selling generic versions. Roche’s prescription market share of the drug is now below 5 percent, the company said.

The company faces as many as 5,000 personal injury claims over Accutane, said Michael Hook, a Pensacola, Florida based attorney, who won a $10.5 million verdict against the drug maker over the medicine in April 2008. “We’ve been winning the cases with the drug still on the market, but this move certainly isn’t going to hurt us going forward”, Hook said in an interview today.

Use of Accutane has been linked to birth defects and depression. Users allege that the drug maker failed to properly warn that the medicine could cause inflammatory bowel disease.

For more information see: http://www.bloomberg.com/apps/news?pid=20670001&sid=aRyzfbTsj3h8

Labels: acne, cancer drug, FDA, Florida, personal injury

The U.S. Center for Disease Control and Prevention (CDC) announced today that it plans to reinstate booster shots of the vaccine HiB (Haemphilus influenza type b) for babies and toddlers ages 12 to 15 months. The vaccine protects against bacterial meningitis.

In 2007 Merck & Company Inc. recalled its HiB vaccines due to the fact that some of the production equipment used was not properly sterilized. The CDC said that the HiB vaccine made by Sanofi Pasteur will increase enough to allow reinstatement of the HiB booster in July. However, due to the short supply of the vaccine there will not be a mass recall to administer the vaccine to older children who missed their booster, stated the CDC.

Before the introduction of the vaccine in the early 1990s, about 20,000 U.S. children would come down with illnesses caused by HiB bacteria a year. Vaccination has cut that by 99 percent, according to the CDC.
For more information see: http://www.reuters.com/article/domesticNews/idUSTRE55O3QZ20090625

Labels: bacterial meningitis, booster shots, children, HiB, vaccine

On June 25, 2009, Health Canada, an organization similar to the FDA, announced new restrictions fro Piroxicam. The agency concluded that piroxicam should no longer be used to treat short-term pain and inflammation because of an increased risk of serious skin reactions and gastrointestinal problems relative to other similar drugs.

Piroxicam is a prescription drug in the family known as non-selective non-steroidal anti-inflammatory drugs (NSAIDs), and is used to relieve pain and inflammation.

The risks associated with its use as a treatment for acute, short-term pain do not outweigh the benefits relative to alternative treatment options. Piroxicam should still be used for chronic pain and inflammation in patients suffering from certain types of chronic arthritis.

The product’s labeling will be updated to reflect the new restrictions. Health Canada is currently working with the manufacturers of these drugs to revise the product monographs. Patients with concerns should contact their physicians.

The FDA made a similar announcement regarding all NSAIDs in May 2009.

Please report any adverse reactions associated with Piroxicam to the FDA.

The 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/ucm150314.htm

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_102-eng.php

Labels: FDA, inflammation, NSAID, pain, Piroxicam

The American Heart Association (AHA) released an advisory that a “clot-busting” drug can be effective for an extra 90 minutes longer than what the FDA has approved the drug for. The drug, called recombinant-tissue plasminogen activator, or rt-PA, is one that can be administered to stroke patients when they enter the hospital and will immediately dissolve clots, possibility preserving patients’ ability to function. The FDA has for the last ten years has set a limit on allowing the drug to only be used within 3 hours of a patient suffering a stroke. The AHA advisory, however, shows that the drug can still be effective on patients if it is administered with 4.5 hours of a patient suffering a stroke.

Rt-PA works almost instantly dissolving clots, which account for more than 85% of strokes. The drug is in effective for the 15% of strokes caused by a burst blood vessel in the brain. Once a stroke patient comes to the emergency room, it can take up to 45 minutes to determine what the cause of the stroke is, often times brining the patient out of the FDA-approved 3 hour window for the drug. A further challenge is getting people to the emergency room on time. Fewer than 25% of people recognize their stroke symptoms soon enough to even get to the hospital in time to be administered the drug.

Using the drug according to the AHA advisory is an off-label use of rt-PA. It is legal to use drugs for an off-label use after the drug has been approved by the FDA, but it is much more risky. This advisory gives doctors that administer the drug past the 3 hour time limit support. The advisory also states that people that aren’t suited for use of the drug after 3 hours are those who are older than 80, those who are on blood thinners for a cardiovascular condition, and those who have diabetes or previous strokes. Barnes-Jewish Hospital has been administering the drug for the extra 90 minute window since the beginning of the year.

For more information, see the St. Louis Post-Dispatch Article at:
http://www.stltoday.com/stltoday/lifestyle/stories.nsf/healthfitness/story/958DD75F122A2F3E862575DF00742BEF?OpenDocument

Labels: American Heart Association, Barnes-Jewish, clot-buster, FDA, rt-PA, stroke

Labels: emergency contraceptive, FDA, Plan B, pregnancy, prescription

According to new data released by the Environmental Protection Agency (EPA), people living in nearly 600 neighborhoods across the country are breathing concentrations of toxic air pollutions that put them at a much greater risk of contracting cancer. The levels of 80 cancer-causing substances released by automobiles, factories, and other sources, in these neighborhoods produce a 100 in 1 million cancer risk. This means that if 1 million people breathed air with similar concentrations over their lifetime, about 100 people would be expected to develop cancer because of their exposure to the pollution.

Parts of Los Angeles, California, and Madison County, Illinois, had the highest cancer risks in the nation. Los Angeles, California’s cancer risk is 1200 in 1 million, and Madison County, Illinois’s cancer risk is 1100 in 1 million, according to the EPA data. People living in parts of Coconino County, Arizona, and Lyon County, Nevada had the lowest cancer risk from air toxics.

“Air toxic risks are local. They are a function of the sources nearest to you”, said David Guinnup, who leads the groups that perform the risk assessments for toxic pollutants at the EPA. “If you are out in the Rocky Mountains, you are going to be closer to 2 in a million. If you are in an industrial area with a lot of traffic, you are going to be closer to 1100 in 1 million.”

For additional information see: http://news.yahoo.com/s/ap/20090624/ap_on_go_ca_st_pe/us_air_toxics

Labels: california, cancer risk, EPA, Los Angeles, pollution, toxics

This week congressional investigators announced that two-thirds of the health insurance industry used a faulty database, which in turned cost patients when seeing doctors outside of the insurance network billions in inflated bills.

The database operated by Ingenix, a subsidiary of UnitedHealth Group, agreed in January to pay $350 million to settle allegations that it deliberately kept rates low to underpay doctors.

Despite paying $350 million, UnitedHealth admits no wrong with how the Ingenix was run, agrees to close the database, and help pay for a new database operated by a nonprofit group. Nearly 20 regional and national insurers also used Ingenix data including Aetna, Wellpoint and Cigna.

Congressional investigators found that companies deliberately skewed data to underestimate the costs of medical services, which left the patients paying more in out-of-pocket expenses.

“The result of this practice is that American consumers have paid billions of dollars for health care services that their insurance companies should have paid,” according to the report of the Senate Commerce Committee’s investigative staff.

For more information please see: http://commerce.senate.gov/public/index.cfm?FuseAction=PressReleases.Detail&PressRelease_id=fa6a7cdf-001b-470a-b2c0-175755fff152&Month=6&Year=2009

Labels: aetna, cigna, health insurance, Ingenix, senate, UntiedHealth, wellpoint

The public interest group, Judicial Watch, recently obtained records from the FDA documenting 28 deaths in 2008 associated with Gardasil, the vaccination for human papillomavirus (HPV). In 2007, there were just 19 deaths. The total number of Gardasil associated deaths is 47 since the vaccine was approved in 2006. Overall, the FDA documented 6,723 adverse events in 2008, of which 1,061 were considered serious, and 142 considered life threatening.

Of the 47 reported deaths, 41 occurred within a month of receiving the vaccine and of those 17 were within two weeks or receiving the vaccine. In most of the deaths, the cause is still unknown.

Sixty-two developed genital warts after receiving the vaccine. Gardasil, which is designed to prevent two strains of genital warts, is not supposed to react with other HPV strains.

One woman developed full-blown cervical cancer within 15 months from the completion of the Gardasil vaccination. The patient now has the difficult choice of having a hysterectomy or receiving treatment in hopes that she may be able one day to conceive children.

Please report any adverse events associated with Gardasil to the FDA.

The 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.judicialwatch.org/news/2009/jun/new-fda-records-obtained-judicial-watch-indicate-28-deaths-related-gardasil-2008

Labels: death, FDA, Gardasil

A study published in the Archives of Internal Medicine found that physicians frequently fail to report abnormal test results to patients. The study included 5,434 patients, ages 50 to 69, from 23 primary care practices in the Midwest and on the West Coast. Researchers looked at various tests such as cholesterol blood work, mammograms, Pap smears, and screening tests for colon cancer. The results proved that only 1 out of 14 abnormal test results were reported to patients.

“Failure to report abnormal test results can lead to serious even lethal consequences for the patient,” said Dr. Lawrence Casalino, the leader of the study, and chief of the Division of Outcomes and Effectiveness Research at Weill Cornell Medical College. “If you’ve had tests, whether it be a blood test, or some kind of X-ray, or ultrasound, don’t assume because you haven’t heard from your physician that the result is normal.”

Failing to inform patients can lead to malpractice lawsuits and increased medical costs, researchers said. Thus according to researchers, patients should make a conscience effort to follow up with their physicians after having tests performed.

For more information see: www.sciencedaily.com/releases/2009/06/090622163031.htm

Labels: blood tests, doctors, malpractice, test results

Fish oil and vitamin D will be studied to see if either or both lowers a healthy person's risk of developing cancer, heart disease or a stroke. Vitamin D deficiency is connected with higher rates of cancer, heart problems and/or stroke. Fish oil, or omega-3 fatty acid, are widely promoted for heart health.

The study will consist of 20,000 people with no history of heart attacks, stroke or a major cancer, women 65 or older and men 60 or older. Participants will be randomly assigned to take vitamin D, fish oil, both nutrients, or placebo pills for five years.

One quarter of the study participants will be African Americans. People with a dark complexion are unable to make much vitamin D from sunlight. A deficiency in vitamin D may help explain why African Americans have higher rates of cancer, stroke and heart disease. It may also explain why people from Northern regions, where the sunlight is weaker in the winter, are more likely to develop cancer.

The National Cancer Institute, along with other federal agencies, will sponsor the $20 million study. Pharmavite LLC of Northridge, Calif., will provide the vitamin D pills, and Ocean Nutrition Canada Ltd. of Dartmouth, Nova Scotia, will provide the omega-3 fish oil capsules.

For more information please see: http://www.msnbc.msn.com/id/31491531/ns/health-diet_and_nutrition/

Labels: cancer, Children Vitamins, Fish Oil, heart disease, sunlight, Vitamin D

President Obama signed legislation Monday that gives the FDA the power to regulate the tobacco industry. The bill, called the Family Smoking Prevention and Tobacco Control Act, gives the Food and Drug Administration the power to regulate how tobacco is manufactured, marketed, and sold. The Act gives the FDA the authority to ban candy and fruit flavored cigarettes, often thought to be especially enticing to youths. The Act also prohibits tobacco companies from marketing their cigarettes as “light”, “mild”, or “low-tar”. Also as a result of the Act, tobacco companies will be required to lower the level of nicotine in their cigarettes and advertising for tobacco products will be restricted.

When signing the bill, the President noted that despite the fact that the percentage of Americans who smoke has significantly decreased over the last few decades, about 400,000 people still die every year from tobacco related illnesses. Health care costs for tobacco related illnesses also cost about $100 billion a year.

For more information, see:
The CNN article:
http://www.cnn.com/2009/POLITICS/06/22/obama.tobacco/index.html?eref=rss_health

Labels: cigarettes, Family Smoking Prevention and Tobacco Control Act, FDA, Obama, tobacco

In a report released by the New York Department of Investigation, staffers at a Brooklyn hospital were accused of falsifying medical records and lying to authorities in an attempt to cover up the neglect of a patient who died on the waiting room floor.

According to the report, Esmin Green, 49, was left sprawled on the emergency room floor for nearly 24 hours when she collapsed from a blood clot. After Green died, a senior nurse at the hospital made three false entries in Green’s medical records to make it appear as though she had been checking on the patient regularly. In actuality, Green had been ignored which was evidenced by a security camera capturing footage of her collapse and slow death. The nurse subsequently admitted that she fabricated entries into Green’s medical records because she was afraid of losing her job.

The city, which owns and operates the hospital, has settled a wrongful death lawsuit with Green’s family for $2 million. However, Green’s family and relative stated that they hope the investigative report will lead to a criminal prosecution.

A spokesman for Brooklyn District Attorney Charles Hynes said the office is reviewing the report, but declined to comment on whether criminal charges will ensue.

Labels: blood clot, emergency room, hospital, medical records, NYC, wrongful death

A promising new melanoma liver cancer treatment directs therapy directly at the liver. The procedure, percutaneous hepatic perfusion, or PHP, targets tumors with a dose of chemotherapy 10 times stronger than patients could tolerate intravenously. Doctors use a specially designed system of catheters and filters to apply the cancer-fighting drug only to the liver, reducing the risk of damaging nearby organs and minimizing possible side effects.

The liver is resilient and unlike other organs can tolerate large amounts of chemotherapy. It is one of the largest organs in the body and is essential for general health. The liver removes harmful material from the blood, aids in digestion of food and converts food into nutrients for a healthy and active life. However, cancer can severely impair the liver's ability to perform these crucial functions, and often times when cancer originates in or spreads to the liver, the tumors in the liver can lead to death. When cancer originates in the liver it is called primary liver cancer. Cancer that has spread to the liver from other parts of the body is called secondary, or metastatic, cancer in the liver.

Doctors say PHP is an important step because people who have melanoma liver cancer usually don't live very long. Slightly fewer than 70,000 new cases of this type of cancer will be diagnosed this year in the United States, according to the American Cancer Society. Although it is not the most common of all skin cancers, it is the most deadly. Ocular melanoma is much rarer, with about 2,500 new cases detected each year. The cancer is often lethal if it spreads to the liver, which is the most common site for it to metastasize.

During the procedure, patients receive doses of a drug called melphalan for 30 minutes every four weeks. The treatment takes place in an operating room while the patient is under an anesthetic. The chemo drug is delivered by a catheter that is threaded up a major artery in the patient's groin into the main artery that goes into the liver. Another catheter is placed in the major vein behind the liver, and balloons on the catheter are inflated to direct all the blood flowing out of the liver into a filter outside the body. This filter system removes almost 90 percent of the chemotherapy from the blood, and the blood is then given back to the patient through a catheter placed in a large vein in the neck.

For more information on the clinical trial please see: http://www.livercancertrials.com/

Labels: cancer, clinical trials, Liver, melanoma, percutaneous, php

A federal grand jury last week indicted Pamela Arrey of Maryland for health care fraud and aggravated identity theft, announced U.S. Attorney Rod. J. Rosenstein. Ms. Arrey owned two pharmacies operating under the trade name of the Medicine Shoppe. According to the indictment, Ms. Arrey claimed reimbursement from Medicare and Medicaid for “refills” of prescriptions that patients never requested, nor were those prescriptions ever dispensed. Ms. Arrey was also indicted for identity theft for using the identity of patients to carry out the scheme.

If convicted, Ms. Arrey can face up to 10 years in prison for each of the 12 counts of health care fraud and two years for each of the 2 counts of aggravated identity theft. Further, the indictment seeks forfeiture of property obtained by Ms. Arrey as a result of the scheme, including $350,000 in residential property.

For more information, see the U.S. Attorney News Release at:
http://www.fda.gov/downloads/NewsEvents/Newsroom/PressAnnouncements/UCM168091.pdf

Labels: Fraud, Indictment, Medicaid, Medicare, Medicine Shoppe, Pharmacy, prescription, U.S. Attorney

Labels: e.coli, FDA, nestle cookie dough recall, nestle recall

Mary Holloway, a former Pfizer Regional Manager, was sentenced today for violating the Food, Drug and Cosmetic Act, for marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration.

A magistrate judge sentenced Holloway with a $75,000 fine and twenty-four months of probation after she pleaded guilty to distributing a misbranded drug, Bextra.

From November 2001 - April 2005, Holloway was responsible her region’s Bextra sales. Bextra, approved in 2001, was a treatment option for osteoarthritis, adult rheumatoid arthritis and primary dysmennorhea. The FDA, however, specifically denied Pfizer’s request to approve it for acute pain such as after surgery pain. Specifically, the FDA was concerned with study results that showed there were excessive cardiovascular events in patients who had undergone coronary artery bypass graft surgery and used Bextra.

Holloway, aware of the FDA’s safety concerns and rejection of Bextra for certain uses, had her sales staff of 100 employees sell Bextra for precisely the uses that the FDA refused to approve. For example, Holloway trained and encouraged her sales teams to promote Bextra by informing doctors that Bextra could be used for the pain of surgery, an unapproved use. Holloway also instructed her staff to market Bextra for use before, during and after surgery to reduce the risk of deep vein thrombosis, which is a form of life threatening blood clots, even though she knew there were no studies showing that Bextra was safe and effective for this use. Finally, Holloway, in general, encouraged her staff to make false safety claims about Bextra in order to increase sales.

Acting United States Attorney Michael K. Loucks said, “We will continue to hold individuals responsible for their conduct in promoting pharmaceutical drugs outside of the uses for which they have been found to be safe and effective by the FDA. The conduct at issue here undermined the FDA’s regulatory scheme and put patients at risk for the purpose of pursing profits for the individual and the pharmaceutical company.”

Bextra was withdrawn from the market in April 2005.

For more information please see: http://www.usdoj.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/June2009/HollowayMarySentencingPR.html

Labels: Bayer, Center for Science in the Public Interest, FTC, One a Day, prostate cancer, selenium, Vitamins

The EPA announced on June 17, 2009 that Libby Montana is the center of a Public Health Emergency because hundreds of asbestos-related disease cases have been documented in the small community.


This is the first time EPA has had determined a public health emergency exists under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Investigations performed by the Agency for Toxic Substance and Disease Registry have found asbestosis, a lung condition, in the Libby area occurred at substantially higher than the national average rate from 1979-1998.


“This is a tragic public health situation that has not received the recognition it deserves by the federal government for far too long. We’re making a long-delayed commitment to the people of Libby and Troy. Based on a rigorous re-evaluation of the situation on the ground, we will continue to move aggressively on the cleanup efforts and protect the health of the people,” said EPA Administrator Lisa P. Jackson.


The Libby asbestos site has been on the EPA’s Superfund National Priorities List since 2002, and cleanup began in 2000. Progress has been made in removing asbestos from the land and air. The risk of lung cancer, asbestosis, and other respiratory problems has decreased. While EPA’s cleanup efforts have greatly reduced exposure, actual and potential releases of amphibole asbestos remain a significant threat to public health in that area.

The Libby asbestos site includes portions of the towns of Libby and Troy and an inactive vermiculite mine seven miles northeast of the town.

Gold miners discovered vermiculite in Libby in 1881; in the 1920s the Zonolite Company mined the vermiculite. In 1963, W.R. Grace bought the Zonolite mining operations. The mine closed in 1990.

It is estimated that the Libby vermiculite mine was the source of over 70 percent of all vermiculite sold in the United States from 1919 to 1990. There was also a deposit of asbestos at that mine, so the vermiculite from Libby was contaminated with asbestos. Vermiculite from Libby was used in the majority of vermiculite insulation in the U.S. and was often sold under the brand name Zonolite.

More information: http://www.epa.gov/libby

Stolen Levemir Insulin may be Dangerous

Labels: insulin, Levemir, Stolen

UPDATE: A federal advisory committee on Tuesday recommended approval of a drug developed by Savient Pharmaceuticals to treat severe cases of gout. The Advisory Committee's recommendation, although not binding, will be considered by the FDA in its review of the Biologics License Application that Savient has submitted for Krystexxa. The FDA usually follows the advice of its advisory committees.

The 14-to-1 vote for approval reflected a general consensus that the effectiveness of the drug in relieving severe pain and disability outweighed the risk of allergic reactions and suggestions that it could cause cardiovascular problems.

Gout is an exceedingly painful form of arthritis that afflicts the big toe and other joints. It is estimated that two million to six million Americans have gout. Krystexxa is intended for only about 50,000 Americans with gout who cannot be treated with other drugs.

In clinical trials, the drug worked for about 40 percent of patients, in some cases bringing marked improvement.

The small size of the studies made it impossible to determine whether an increase in heart problems among those taking Krystexxa was caused by the drug or was just chance. If the drug is approved, the advisory panel recommends further studies on Krystexxa safety and its use carefully restricted to those not helped by other therapies.

A handful of gout patients testified that the drug had dissolved unsightly and disabling lumps on their bodies, called tophi, and allowed them to walk or use their hands again. Savient paid for hotels and transportation for some patients to attend the meeting, which was in Silver Spring, Md.

Though Savient has not named a price for their drug, analysts estimate treatment to cost tens of thousands of dollars a year.

The FDA is expected to make a decision as to whether to grant marketing approval for Krystexxa by August 1, 2009.

For more information please see: http://investor.savient.com/ReleaseDetail.cfm?ReleaseID=390150

Labels: cardiovascular, FDA, Gout, Krystexxa, treatment

Yesterday on June 15, 2009 Hi-Tech Pharmaceuticals recalled its weight loss supplement Stamina-Rx. Stamina-Rx contains benzamidenafil, an undeclared and not FDA-approved ingredient.

Hi-Tech Pharmaceuticals, Inc. of Norcross, GA manufacturers Stamina-Rx.

On May 1, 2009, the FDA notified Hi-Tech that its lab analysis of Lot 08141578, Exp. 9/10 of Stamina-Rx contains − benzamidenafil − a Phosphodiesterase Type 5 (PDE5) inhibitor. PDE5 inhibitors, like FDA-approved sildenafil, tadalafil, and vardenafil treat erectile dysfunction (ED).

Benzamidenafil is not FDA-approved, and poses a threat to consumers. Benzamidenafil can interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.

In addition to the one lot described above, Hi-Tech is recalling all other lots of Stamina-Rx because it is an unapproved new drug and misbranded new drug in violation of the Federal Food, Drug and Cosmetic Act (the Act). Stamina-Rx is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling posted on certain web-based and print media.

Hi-Tech has been under a Consent Decree of Permanent Injunction with the FDA since September 23, 2003. In accordance with the Decree, the FDA determined that additional corrective actions were necessary for Hi-Tech to achieve compliance with the Act and the Decree and therefore, on May 1, 2009 the FDA ordered Hi-Tech to recall all lots of Stamina-Rx to the consumer level.

Customers who have this product in their possession should stop using it immediately. For more information regarding the recall contact: Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

Please report any adverse events associated with Stamina-Rx to the FDA’s MedWatch program.

The 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/Safety/Recalls/ucm167139.htm

Labels: diabetes, FDA, Hi-Tech, Stamina-Rx, viagra

President Barak Obama plans to announce today his decision to extend federal benefits to same-sex partners of federal employees. Obama is making this announcement after getting sharp criticism for not seeking to end the “don’t ask, don’t tell” policy of the U.S. military. The “don’t ask, don’t tell” policy bars officials from asking a service member about his/her sexual orientation, but it also means that service members can be discharged from the military if they are openly homosexual.

Obama is expected to release more information about the extension of benefits today. This announcement also follows criticism over a Justice Department motion that was filed last week in support of the Defense of Marriage Act (DMA). The DMA opposes same-sex marriages. The criticized motion filed by the Justice Department used the government’s interest in opposing incestuous marriages to support the argument against same-sex marriages.

For more information, see the article from MSNBC:
http://www.msnbc.msn.com/id/31396079/ns/politics-white_house/

The article from CNN:
http://www.cnn.com/2009/POLITICS/06/16/obama.same.sex.benefits/index.html

Labels: benefits, Defense of Marriage Act, government, Obama, Same-sex marriage

Labels: blindness, FDA contact lenses, real housewives of new jersey

The FDA announced today a warning concerning loss of smell associated with the use of the over the counter cold remedy, Zicam. The FDA has received reports of over 130 cases of ansomia, or loss of smell, associated with the use of Zicam. Zicam is an intranasal product that contains zinc. The agency urged consumers to quit using the product and to throw away any Zicam that they may already have at home. Zicam is marketed as an over the counter cold remedy that can shorten the length and severity of the common cold.

The effected products are:
• Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)• Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)• Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21) (this has already been discontinued)

The products are sold in retail stores and pharmacies without a prescription. Zicam Kids Size has already been discontinued, but the FDA is concerned that some people may still have the product in their homes. The FDA has special concerns about the use of zinc in children. The anosmia that can be experienced by consumers can either be temporary or permanent.

The FDA sent a warning letter to Matrixx Initiatives, the manufacturer of Zicam, stating that they can no longer sell their product without FDA approval and that their warnings regarding the loss of the sense of smell are adequate. “Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of the FDA’s Center for Drug Evaluation and Research Office of Compliance.

Anyone who has used this product and experiences a loss of the sense of smell should report the incident to their doctor right away. Any problems should also be reported to MedWatch. Consumers can report problems to MedWatch either online through the FDA’s website, or they can call at 1-800-FDA-1088.

For more information, see the FDA Consumer Update:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm166931.htm

The FDA News Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm

The FDA Safety Information
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166996.htm

The FDA Public Health Advisory:
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm166059.htm

Labels: anosmia, Common cold, FDA, MedWatch, zicam

In a U.S. study released today, researchers found that a cream used to treat the early signs of skin cancer may erase wrinkles and leave behind younger- looking skin. Researchers say Valeant Pharmaceuticals’’ cream Efudex, which is used to treat actinic keratoses, a precancerous form of squamous cell carcinoma, improved the appearance of skin. Efudex apparently smoothes out rough spots and wrinkles, while improving skin color, and erasing brown spots. The cream appears to cause a wound healing response that leads to an increase in collagen production, which improves the appearance of wrinkles.

The study was performed on 21 individuals, aged 56 to 85, with actinic keratoses and sun damage. The volunteers used the cream twice daily on the face for two weeks Researchers measured changes in the skin by taking facial biopsies over a six-month period. The drug had a significant effect, causing people’s skin to be much softer. The researchers also noticed that skin appeared to be less yellow and more even toned with fewer brown spots.

However, treatment with Efudex, known as fluorouracil, is not trouble free. According to Dr. Dana Sachs of the University of Michigan, shortly after the cream is applied, the skin becomes red and inflamed. “Patients look really bad. Their skin is red. I’ve had people describe it as looking law raw hamburger meat.”

Labels: brown spots, cancer, cancer cream, Collagen, Efudex, zicam

FoodScience Corporation of Essex Junction, Vermont voluntarily recalled approximately 1, 250 bottles of its Children’s Multi- Vitamins. The recalled was initiated after FoodScience workers discovered that there was an error on the label. The label indicated that the suggested use for children ages 3-5 was 1 chewable tablet, and children ages 6-12, 2-3 chewable tablets. However, the label should have read ages 4-16 take 1 chewable tablet daily.

Although no illness or adverse events have been reported to date in connection with this product, this product could pose a risk to children if taken for an extended period of time.

This product is packaged in white bottles with a white child resistant bottle cap. The lot number is stamped vertically to the right side of the supplemental fact panel on each label. The following is a list of the products and the lot numbers:

DaVinci Laboratories of Vermont Kid's Mighty Vites (90 tablet bottle) Lot #s 6741500 0311 and 6741600 0311 and 6988100 0311FoodScience of Vermont Kids Superior (90 tablet bottle) Lot #s 6741500 0311 and 6741600 0311and 6988100 0311 and 7198100 0311Mountain Naturals of Vermont Kid's Superior (90 tablet bottle) Lot #s 6741700 0311Sherlock Vitamins Smart Strong Focus (60 tablet bottle): Lot # 6747900 0311 Elders International, Inc. M10-8® Kids IQ Secret (90 tablet bottle): Lot # 6830700 0311Guyer Institute HEALTHY KIDS MV (90 tablet bottle): Lot # 6784400 0311

Consumers who have purchased the product and lot number in the above listing are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-451-5190 and ask for Recall Assistance.

For additional recall information see: http://www.fda.gov/Safety/Recalls/ucm166346.htm

Labels: Children Vitamins, FDA, Kids Multivitamin

The Food and Drug Administration said Friday, June 12, 2009, Krystexxa may successfully treat gout, despite evidence of potentially deadly side effects.

Krystexxa is manufactured by Savient Pharmaceuticals of New Jersey.

Krsytexxa’s new drug application has been under review since December. The FDA already has delayed a decision on the drug once.

Krystexxa is an injectable enzyme designed to lower the body's uric acid levels when administered either once or twice a month. Gout is a condition caused by a buildup of uric acid in the body. The drug appears to reduce gout’s symptoms such as relieving swollen joints and pain flare up. Gout affects about 8 million Americans and is most common in men over 40.

In a clinical study, about 24 percent of patients taking Krystexxa suffered a serious side effect, compared with 12 percent of patients taking a placebo pill. There were six deaths among patients taking the drug compared with three among patients taking placebo, though FDA noted many of them had pre-existing heart conditions.

"Because most of the patients developing the serious cardiovascular adverse events had other cardiovascular risk factors... there was uncertainty concerning whether the cardiovascular adverse events represent a genuine safety signal," states Dr. Bob Rappaport, FDA's director for rheumatology products, in a review posted to the agency's Web site.

The FDA is scheduled to ask a panel of outside arthritis experts next Tuesday to weigh in on the drugs risks and benefits. Though not required not required to follow the group's advice, the FDA generally adopts their recommendations. A final decision on Savient's drug is expected by the end of July.

It is possible that the FDA will consider whether additional studies are needed to evaluate Krystexxa's impact on the heart.

An analyst said the drug can likely win approval so long as the company agrees to limit its use to the target patient population and closely monitor negative side effects. The company is specifically seeking an indication for gout patients who are not receiving relief from other treatments.

For more information: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm155149.htm

Labels: death, drug application, enzyme, FDA, Gout, Krystexxa, savient, uric acid

On Friday, the FDA provided a follow up report from their March 2008 and January 2009 safety reports regarding a certain class of asthma drugs known as leukotriene modifiers. The FDA is now recommending a label change, wherein manufacturers should include in their label a warning concerning neuropsychiatric events that have been reported. The drugs that are affected by this recommendation are: montelukast (brand name Singulair), zafirlukast (brand name Accolate), and zileuton (brand name Zyflo and Zyflo CR). The neuropsychiatric events that have been reported are mostly behavioral, such as mood changes, anxiousness, dream abnormalities, and hallucinations.

Leukotriene modifiers are drugs that mainly are used to treat asthma, but some are also used for allergies. Leukotriene is a chemical released by the body in response to an inflammatory stimulus such as when an allergen is inhaled by a person. Montelukast and zafirlukast block the receptor sites for leukotriene. Zileuton is a leukotrine inhibitor, which blocks the production of leuktotriene all together.

For more information on the FDA report, see the FDA press release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm166293.htm

See the Post-market Drug Safety Information:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm

See the MedWatch information:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166246.htm

Labels: Accolate, Asthma, FDA, leukotriene, neuropsychiatric, Singulair, Zyflo

On June 11, 2009, the FDA approved Caldolor, which is the first injectable form of the common pain medication, Ibuprofen. Ibuprofen is used to treat fever and pain.

Caldolor will be available only for hospital use. It is approved to be administered in 400 mg to 800 mg doses, over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100-200 mg every 4 hours, as necessary.

Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research. “But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”

In a study done using Caldolor, 319 women who had undergone an elective abdominal hysterectomy were less likely to request morphine for pain when Caldolor was administered.
Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, risk of blood clots, and those who have a prior history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. The drug has also been associated with high blood pressure, serious skin reactions, and serious allergic reactions.

The most common adverse reactions reported were nausea, flatulence, vomiting, and headache.

Labels: Caldolor, FDA, Ibuprofen, medicine

The FDA announced yesterday that it was issuing a Class I recall of certain Medtronic Kappa and Sigma pacemakers. The products can fail due to a separation of wires that connect the components of the pacemaker, such as the battery, to the electronic circuit of the pacemaker.

The FDA changed the classification of the pacemakers from last month’s “physician advisory” to a Class I recall. There are currently lawsuits filed all over the country by consumers that were harmed by another one of Medtronic’s products, the Sprint Fidelis defibrillator, which has since been recalled.

There are more than 1.7 million Medtronic pacemakers implanted into people in the United States. Of those, only about 21,000 are affected by this recall. Most of those devices that have been recalled have been implanted in patients for five years or longer. The products that are being recalled are Kappa series 600/700/900 and Sigma series 100/200/300.

Patients with malfunctioning pacemakers may experience symptoms such as an abnormal heart rate, light-headedness or dizziness, and in rare cases, serious injury or death.

To find out if your pacemaker has been recalled, contact Medtronic at 1-800-505-4636, or go to their website at: http://www.kappasigmasnlist.com/.

For more information, see the FDA recall at:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm165619.htm

See the FDA Press Release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm165853.htm

Labels: FDA, Kappa, medical device, Medtronic, Pacemaker, Sigma, Sprint Fidelis

Both Yaz® and Yasmin® are birth control pills offered by Bayer Healthcare. They have become popular so that doctors prescribe them often. However, you could suffer from severe side effects such as:

• Stroke
• Heart attack
• Pulmonary embolism
• Deep vein thrombosis
• Gallbladder disease
• Kidney damage

These pills could even cause sudden death. They are combination oral contraceptives but differ from the others by containing a new kind of progestin hormone. It is known as drospirenone or drsp. It can increase your blood potassium level and that can be life-threatening if you have any liver, kidney, or adrenal gland problems.

Yaz Marketed for Non-Approved Uses
Yaz does have FDA approval for treating PMDD (Pre-Menstrual Dysphoric Disorder) which is similar to PMS (Pre-Menstrual Syndrome) but with more severe symptoms. But it does not have FDA approval for treating either PMS or acne.

Bayer Healthcare has nevertheless been marketing Yaz for the treatment of PMS and acne. In October, 2008 the FDA sent a warning to Bayer, citing them for violating some provisions in the Federal Food, Drug, and Cosmetic Act. Some of Bayer's advertising is thought to minimize serious risks and overstate Yaz' effectiveness.

If you are taking any medication such as Motrin, Advil, Heparin, or any ACE inhibitors, which raise your blood potassium level, you would be at risk if you used Yaz or Yasmin. To learn more and to schedule a free consultation with one of our pharmaceutical drug lawyers, please contact our law office today.

Labels: YAZ

On June 11, 2009, the FDA altered healthcare professionals a clinical trial suggests sirolimus may be associated with an increased morality rate. The study compared the mortality rate of stable liver transplant patients who converted from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune) to those who remained on a CNI regimen.

The trial was conducted by sirolimus’ manufacturer, Wyeth. After one year, the overall treatment failure rates were significantly higher for the patients converted to sirolimus compared to those that continued on CNIs. Treatment failure is measured by the occurrence of acute rejection or premature discontinuation for any reason. Patients on sirolimus discontinued its use due to an adverse event more often than CNI patients. Sirolimus’s most frequent adverse events were peripheral edema, stomatitis, rash, and mouth ulceration.

Currently, Sirolimus is approved for treating prophylaxis of organ rejection in patients aged 13 years or older receiving kidney transplants. The safety and efficacy of this drug in liver or lung transplant patients have not been established by the FDA.

The current Boxed Warning of sirolimus indicates that the use of sirolimus in combination with tacrolimus was associated with excess mortality and graft loss in a study in de novo liver transplant patients. Many of these patients had evidence of infection at or near the time of death.

The FDA is examining this information and will make the appropriate recommendations. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy.

At this time, FDA has not made any changes to the professional label for sirolimus.
Any adverse events associated with Sirolimus should be reported to the FDA.

The 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 information please see: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165015.htm

Labels: CNI, death, kidney failure, Liver, Rapamune, sirolimus, transplant, Wyeth

A large study done in Israel shows that pregnant women who suffer from morning sickness are not risking harm to their babies if they take a certain anti-nausea drug. This result may lead more doctors to prescribe the drug Metoclopramide, sold as Reglan, to women who are experiencing morning sickness.

The study, which was led by researchers at Ben- Gurion University, looked at 82,000 births, and was performed from 1998 until 2007. Researchers compared the health of newborns of 3, 458 women who took Metoclopramide, for as little as a week to more than three weeks, with 78,245 newborns of women who did not use Metoclopramide. The study showed that there were no differences in defects or other problems in newborns of women whether or not they had taken the drug.

“I think that women will be comforted by this,” said Dr. Keith Eddleman, director of obstetrics at Mount Sinai Medical Center in New York. “Most women are reluctant to take anti-nausea medicine just because of the stories they have heard about the perception that taking something in the first trimester can cause harm.”

Despite the large number of births each year, there still have not been any large, well- designed studies on the safety of medicines in treating morning sickness in the U.S., mainly due to fears of harming a fetus and triggering lawsuits.

In the U.S., Compazine, Phenergan, and Zofran, are used more often than Reglan, which is made by Schwarz Pharma Inc. Some experts say that the new study should lead obstetricians to prescribe it more often.

However, while the children of mothers who take Reglan have not been found to be affected, many consumers of Reglan have reported adverse events. Reglan can cause a rare disease called tardive dyskinesia. This disease is irreversible and generally untreatable. Some symptoms of this disease are shaking of the extremities, trouble controlling facial movements, and trouble swallowing. Anyone who has taken Reglan for more than 90 days and is exhibiting these symptoms should contact an attorney at Schlichter, Bogard, and Denton to discuss your legal rights.

Labels: medicine, morning sickness, nausea, pregnancy, Reglan

Gardasil’s fainting warning is more prominently warns that fainting can occur following administration of the vaccine. The FDA reports some Gardasil fainting victims have suffered from jerking movements and other seizure-like activity. Additionally, some have had severe injuries from falling.

Gardasil, manufactured by Merck & Co. of New Jersey, was approved by the FDA in June 2006. At the time of its approval, Merck & Co. said clinical trials had shown the drug to be between 90-100 percent effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. The U.S. Centers for Disease Control and Prevention (CDC) recommends that all young girls age of 11 and 12 receive the Gardasil vaccine. Gardasil is approved for females age nine to 26.

Gardasil has been controversial because Merck & Co. has attempted to make it mandatory and because of lingering questions about its safety. From June 2006 through January 2009, 9,749 adverse reactions have been reported. Twenty-one of the reports were deaths. Additional side effects include: 10 miscarriages, 78 severe outbreaks of genital warts, and 6 cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis. Side effects were reported to the FDA and CDC via the Vaccine Adverse Event Reporting System (VAERS).

The FDA reports approximately 13 % of Gardasil side effects reported to VAERS describe fainting. Fainting is a common side effect associated with vaccines. Fainting often occurred while still in the healthcare provider’s office, and other fainting episodes resulted in motor vehicle accidents. Though the fainting side effect has been on the label since 2007, the prominence of the warning is being increased because of continued fainting reports.

The FDA has asked Merck & Co. to list fainting risks under the "Warnings and Precautions" section of the Gardasil label. The revised label reminds healthcare providers that recipients of Gardasil should be closely observed for 15 minutes after vaccination. Gardasil recipients should remain seated or lying down for this length of time and be alert to the following warning signs and symptoms that may happen before a person faints: paleness, sweating, dizziness, ringing in ears or vision changes.

Any adverse reports associated with Gardasil should be reported to the FDA.

The 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

Please see: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm

Labels: attorney, CDC, fainting, FDA, Gardasil, lawyer, sunchaser swing set

The FDA recently sent General Mills a Warning Letter informing General Mills that certain statements made in the advertisements for Cheerios violate the Food and Drug Act. The FDA determined that these claims were improper because the claims would cause Cheerios to be classified as a drug, rather than a food. This would violate the Food and Drug Act because General Mills has not taken the proper steps to have Cheerios approved as a drug.

The claims made by General Mills that would cause Cheerios to be categorized as a drug, rather than a food, are:

• "you can Lower Your Cholesterol 4% in 6 weeks"
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

The problem with these statements, according to the FDA, is that they are not adequately supported by scientific studies. However, this appears more to be an issue of semantics than safety, as the FDA recognizes that soluble fiber from whole grain oats (the main ingredient in Cheerios) is associated with lowering cholesterol and reducing the risk of heart disease. General Mills does state on the front of the Cheerios box that the whole grain oats found in Cheerios contain soluble fiber, which can lower cholesterol and the risk of heart disease. However, the above claims about lowering cholesterol appear on the back of the Cheerios box. The FDA suggests that the claims regarding cholesterol on the back of the box would have been proper if General Mills had put them on the same side of the box as the claim about soluble fiber.

Adverse events associated with pharmaceutical drugs and devices are suffered and reported on a daily basis. Many of these drugs and devices cause serious, life-threatening injuries. In the case of Cheerios, however, the FDA recognizes that there are no safety concerns associated with Cheerios, and in fact, consumption of whole grain foods such as Cheerios is encouraged. The public would be better served if the FDA focused their efforts toward policing these dangerous drugs and devices, rather than picking on Cheerios, which the FDA admits is safe and encourages people to consume as part of a healthy diet.

Labels: Cheerios, cholesterol, coronary, drugs, FDA, fiber, food, heart disease, oats, soluble fiber, whole grain

Middle-aged adults who get too little sleep are more likely to develop high blood pressure. Missing just one hour of sleep a night over five years raises risk of high blood pressure by 37 percent.

"People who didn't sleep as much were at greater risk of developing hypertension over five years," Kristen Knutson of the University of Chicago reported in the Archives of Internal Medicine on Monday.

Adults typically should sleep between seven and nine hours a night, according to the U.S. Centers for Disease Control and Prevention.

Sleeping too little has different negative health affects depending on age. In children, lack of sleep has been shown to raise rates of obesity, depression and high blood pressure. In older adults, it increases the risk of falls. And in the middle-aged, it raises the risk of infections, heart disease, stroke, cancer and high blood pressure.

The team studied 578 adults with an average age of 40. They took blood pressure readings and measured how long each person slept. Only 1 percent slept eight hours or more.

The study participants on average slept six hours. Each hour of lost sleep raised the risk of high blood pressure.

"If you compare six hours of sleep to five hours of sleep, the five-hour sleepers will have 37 percent greater odds of developing hypertension," Knutson said.

Men, especially African American men, slept less then Caucasian women.

"These two observations suggested the intriguing possibility that the well-documented higher blood pressure in African Americans and men might be partly related to sleep duration," Knutson and colleagues wrote.

Please see: http://archinte.ama-assn.org/cgi/content/short/169/11/1055

Labels: 6 hours, cancer, despression, fungal infections, heart disease, high blook pressure, kate cooper, obesity, Sleep, snore, stroke

The FDA announced yesterday that all botulinum toxin products will now require a black box warning for safety purposes. The agency decided to require a stronger warning due to interchangeability problems among the 3 main botulinum drugs and serious adverse events that were being reported. Many of the adverse events reported concerned that the botulinum toxin could spread from the injection site to other areas of the body, causing symptoms similar to those of botulism. Some of these symptoms include: unexpected loss of strength or muscle weakness, trouble talking and saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double/blurred vision, and droopy eyelids. Most of these symptoms have been reported in children that take botulinum drugs for cerebral palsy, but some symptoms have been reported by adults that use botulinum for both FDA approved and unapproved uses.

The products that the FDA is requiring to adopt a new label are:
Botox and Botox Cosmetic
Myobloc
Dysport

All three drugs are FDA approved to treat cervical dystonia, a condition where the muscles in the neck constantly contract. Botox Cosmetic and Dysport are used to temporarily treat “frown lines” between the eyebrows. Also Botox is used for severe underarm sweating, crossed eyes, and abnormal tics of the face. Treatment of muscle spasticity for cerebral palsy is not an FDA approved use of any of the three botulinum drugs.

The FDA wants healthcare professionals to understand that that dosage strength is not interchangeable between the three drugs. A dose in one of the botulinum drugs may be more potent than a dose of another botulinum drug. Also, adverse events have been reported as little as a few hours after the drugs were administered to as long as several weeks after the drugs have been administered.

Anyone who has experienced adverse experiences from the use of the drug should report it to the FDA.

For more information, see the FDA warning page:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149574.htm

See also the FDA’s response to the Citizen Petition at:
http://www.fda.gov/cder/drug/early_comm/botulinum_CP_response.pdf

Labels: Black box label, Botox, botulism, Dysport, FDA, Myobloc, warning

Vitamins may harmful to certain people or under special circumstances. Antioxidants may do more help than harm for some breast cancer patients during radiation or chemotherapy treatments.

"It is possible that if you are taking concentrated high-grade antioxidant vitamins in significant doses, it may interfere with your treatment," says Dr. Marisa Weiss, the president and founder of advocacy group Breastcancer.org .

The upcoming issue of Cancer a study examines the affect high dosages of antioxidants have on breast cancer patients during chemotherapy and radiation treatment. In the study, 60.5 percent of women with breast cancer reported taking antioxidants, including vitamin E, vitamin C, beta carotene, and selenium, during their treatment.

Overall, 69.3 percent of those on antioxidants took high doses or more antioxidants contained in a Centrum multivitamin.

Chemotherapy and radiation both create free radicals within cancer cells. Free radicals damage the cancer cells, which hopefully will ultimately kill them. However, antioxidants absorb free radicals. "In cancer, we create free radical damage to tumor cells with treatment, and we want that, but antioxidants quench this damage," explains Dr. Brian Lawenda, the clinical director of radiation oncology at the Naval Medical Center, in San Diego, California.

Essentially, antioxidants may protect cancer cells from harm just like they protect normal cells. "We have lab data and some clinical data that confirms this," Lawenda says. In healthy people, antioxidants can have beneficial effects by absorbing free radicals linked to aging and other diseases.

Lawedna recommends: "Don't take a high-dose supplement of any antioxidant during chemotherapy and during radiation because we don't know what the effects will be on your treatment."

Still, other physicians believe it is too early to recommend not taking antioxidants during treatment for breast cancer patients like Heather Greenlee, N.D., Ph.D., an assistant professor of epidemiology and medical oncology at the Columbia University Mailman School of Public Health, in New York City. "We need to know if these antioxidants cause benefit or harm. There is the potential for both and we need answers."

Patients should tell their doctor about taking any antioxidants or medication or supplement that may interfere with treatment.

Please see: http://www3.interscience.wiley.com/journal/28741/home?CRETRY=1&SRETRY=0

Amitiza is a medication that was approved by the FDA in Janaury 2006 for the treatment of chronic constipation and later approved in 2008 for treatment of irritable bowel syndrome. However, this medication can have deadly side effects. The advocay group, Public Citizen, has filed a petition with the FDA requesting that Amitiza carry a stronger warning for pregnant women about the risk of early child birth and unintended abortions. In early May 2009, Public Citizen sent their petition to the FDA requesting that not only a "black boxed" warning be prominently displayed, but also that a "Dear Doctor" letter be sent to healthcare providers to inform them about the risks. It is absolutely imperative that all steps be taken to warn women of these terrible side effects associated with the medication, Amitiza. According to the director of Health Research Group at Public Citizen, "The curernt label is grossly inadequate as it lacks useful informaiton pertaining to the risks of drug-induced abortion in pregnant women who take the drug."

Labels: Amitiza, Public Citizen, irritable bowel syndrome, chronic constipation

The Food and Drug Administration (FDA) has released several alerts over the last six months about the illegal and possible dangerous addition of active prescription drug ingredients to otherwise ineffective weight-loss supplements. The FDA has identified 72 weight loss products that illegally contain at least one active prescription drug. The prescription drugs being added to these weight loss products include:

• Sibutramine (MERIDA) - A controlled substance and an appetite suppressant available by prescription only.
• Fenproporex- A stimulant drug that is not approved for marketing in the United States.
• Fluoxetine (PROZAC, SERAFEM) - An antidepressant available by prescription only
• Bumetanide (BUMEX) - A diuretic available by prescription only
• Furosemide (LASIX) - A potent diuretic available by prescription only.
• Rimonabant (ZIMULTI)- An appetite suppressant not approved for marketing in the United States.
• Cetillstat- An experimental obesity drug not approved for marketing in the United States.
• Phenytoin (DILANTIN) An anti-seizure drug available by prescription only.
• Phenolphthalein- A suspected cancer causing agent and a solution used in chemical experiments. This drug is not approved for marketing in the United States.

The FDA warned that these tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages.

If you have any products containing these ingredients, you should stop taking them immediately, and consult your health care providers. In addition, consumers should seek guidance from health care providers prior to purchasing any weight loss products.

Consumers and health care providers should report any side effects of weight loss products to the FDA’s MedWatch Adverse Event Reporting Program. This can be done at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

Labels: drugs, FDA, health care providers, weight loss pills

The FDA released a warning yesterday to consumers that Clarcon Biological Chemistry Laboratory is recalling some of their skin sanitizers and protectants due to the products containing high levels of bacteria.

Consumers should not use any Clarcon manufactured product and any products they possess should be thrown away. Inspections done on many of Clarcon’s over the counter skin sanitizers and protectants revealed high levels of disease causing bacteria. Some of these bacteria can cause infections in the skin and underlying tissue. The FDA warns that some of the resultant infections can cause serious damage, maybe even requiring medical attention and can result in permanent damage. The FDA is particularly concerned about risk of infections because many of Clarcon’s products are advertised as antimicrobial and to be used on open wounds, damaged skin, and to protect against infectious disease.

The FDA urges all health care professionals and consumers that experience any adverse reactions related to Clarcon’s products to contact the FDA’s MedWatch Adverse Event Reporting program at:
--Online --Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 --Fax: 800-FDA-0178 --Phone: 800-FDA-1088

Some of the products being recalled include:
Citrushield Lotion
· Dermasentials DermaBarrier
· Dermassentials by Clarcon Antimicrobial Hand Sanitizer
· Iron Fist Barrier Hand Treatment
· Skin Shield Restaurant
· Skin Shield Industrial
· Skin Shield Beauty Salon Lotion
· Total Skin Care Beauty
· Total Skin Care Work

For more information, see the FDA news release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm164863.htm

See the consumer article:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm164845.htm

Labels: bacteria, Clarcon, Dermassentials, FDA, infection, recall, sanitizer, Skin Shield

Chantix was among the 20 medications under investigation for potential safety issues, according to an updated list from the Food and Drug Administration released on June 4, 2009.





Chantix, a twice daily pill, eases nicotine withdrawal symptoms by blocking the pleasurable effects of nicotine. Chantix is manufactured by Pfizer of New York. Approved in May 2006, Chantix quickly became one of the fastest growing products on Pfizer's balance sheet, though sales fell 4 percent in 2008 to $846 million.

The FDA is investigating reports of injury, visual impairment and other problems connected with Chantix, which is designed to help smokers quit. In 2008, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams.

Regulators first began investigating Chantix in 2007 after receiving several reports of psychiatric problems, including suicidal thoughts. That prompted Pfizer to update the drug's labeling that patients should be monitored for unusual behavior.

Institute for Save Medical Practices, a nonprofit group, highlighted 1,001 reports to the FDA of serious injuries linked to the drug over a three-month period, more than for the 10 best-selling brand name drugs combined.

ISMP found 15 cases of Chantix patients involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The FDA said it taking a second look at the Chantix warnings.

Pfizer said at the time that the high number of reports might be linked to greater publicity about the side effects. It also contends that the drug’s benefits clearly outweigh its risks. “We stand by the efficacy and safety profile of Chantix,” the company said in a statement. “There are few things that provide greater health benefits than quitting smoking. Pfizer is committed to reducing the prevalence of smoking globally. As part of that mission, we want to increase peoples’ understanding of the dangers of smoking and the benefits of quitting.”

The Federal Aviation Administration has banned use of Chantix by pilots and air traffic controllers.

While the current label cautions that patients should not drive or operate heavy machinery, this language is standard for many medications.

Reports of adverse events associated with Chantix should be reported to the FDA.

The 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/ForConsumers/ConsumerUpdates/ucm049088.htm

Labels: car accident, Chantix, david carradine death photo thai, FDA, Pfizer, smoking

According to a study done by Greek doctors, drinking several liters of cola containing soft drinks per day can cause a chronic depletion of potassium in the body, which can lead to muscle weakness and even paralysis.

Dr. Moses Elisaf, an associate at the University of Ioannina in Greece, identified six reports of cola- induced potassium deficiency. Consuming 2 to 9 liters of cola per day resulted in muscle complaints ranging from mild weakness to profound paralysis, and all patients had abnormally low potassium levels.

“Fortunately, all patients had a rapid and complete recovery after the discontinuation of cola ingestion and the oral or intravenous supplementation of potassium”, said Dr. Elisaf.

Dr. Clifford Packer, a doctor at Louis Strokes Cleveland VA Medical Center in Cleveland, Ohio, comments that “there is very little doubt that tens of millions of people in industrialized countries drink at least 2-3 litters of cola per day”.

Packer stresses that “the soft drink industry needs to promote safe and moderate use of its products for all age groups, and pay heed to the rising call for healthier drinks.”

Labels: Coca- Cola, Lisa Ling, muscle weakness, Pepsi, potassium

Reginald Clemons was given a reprieve Friday afternoon. Clemons, who was scheduled to be executed on June 17, was granted a stay by a federal appeals court. Clemons’ lawyers filed the motion to stay the execution because they argued that Clemons would have been executed before a federal court in the western district of Missouri would have a chance to rule on Clemons’ constitutional challenges to Missouri’s system of execution. The 8th Circuit Court of Appeals issued the decision Friday, June 5th. The decision was unsigned and only one page long and it didn’t state the reason for the court’s decision.

The Missouri Attorney General’s office opposed the motion to stay, arguing that all of the constitutional issues raised by Clemons have already been addressed or could have been brought up before now. Clemons, who is now 37, was convicted by a jury in 1993 on two counts of first degree murder for the deaths of two sisters, Julie Kerry, 20, and Robin Kerry, 18. 3 other men were also convicted of playing a part in the crime. The sisters, students at University of Missouri at St. Louis, were stripped, beaten, raped and pushed off of a bridge into the Mississippi River. The sisters’ cousin, Tom Cummins, was forced to watch the assault on Julie and Robin and was ordered to jump off of the bridge as well. Cummins managed to survive the fall. Clemons maintains that he took no part in the actual murder of the Kerry sisters.

For more information, see the St. Louis Post Dispatch story:
http://www.stltoday.com/stltoday/news/stories.nsf/laworder/story/A2EE48B4893BF30A862575CD000A8DED?OpenDocument

Labels: 8th Cir Court of Appeals, clemency, Clemons, Danny Glover, death penalty, Kerry, Missouri, murder, trial

Propylthiouracil (PTU) treats hyperthyroidism (including Graves disease) by decreasing the amount of thyroid hormone produced by the thyroid gland. Its notable side effects include a risk of agranulocytosis. Agranulocytosis is a rare, drug-induced blood disorder that is characterized by a severe reduction in the number of white blood cells in the circulating blood.

Propylthiouracil is only available in the United States as a generic medication. Some manufacturers include Actavis Elizabeth, LLC of New Jersey and West-Ward Pharmaceutical Corp, also, of New Jersey.

Recently on June 3, 2009, the FDA alerted healthcare professionals of the seriousness of hepatic reactions related to PTU. It poses a risk of serious liver injury, including liver failure and death in adult and pediatric patients.

Reports to FDA’s Adverse Event Reporting System suggest there is an increased risk of hepatotoxicity with PTU when compared to methimazole. Metimazole is another treatment option for thyroid disorders. FDA has identified 32 cases (22 adult and 10 pediatric) of serious liver injury associated with PTU use. Although both PTU and Metimazole are treatments of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease.

Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months of treatment.

PTU should not be used in pediatric patients as a last resort. The FDA suggests that PTU only be used in pediatric patients who are allergic to or intolerant of Metimazole, and there are no other treatment options available.

West-Ward’s label from September 2007 does warn of agranulocytosis and of severe hepatic reactions. It is generally perceived the treatment of hyperthyroidism and not the disease itself causes these serious side effects.

Reports of adverse events associated with Propylthiouracil, including liver failure, should be reported to the FDA.


The 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/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164162.htm

Labels: children, death, FDA, hepatic, Liver, PTU

The risk of risperdal and stroke in patients with dementia-related psychosis is serious enough to warrant a black box label. Risperdal has not be shown to be a safe or effective treatment of patients with dementia-related psychosis.

In a letter to healthcare providers dated April 2003, Janssen Pharmaceuticals, the maker of risperidone, described adverse event reports that prompted the label revision: "Cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities, were reported in patients in trials of risperidone in elderly patients with dementia-related psychosis." The controversial aspect of this Risperdal stroke announcement was the fact that Johnson & Johnson had already issued a Canadian Risperdal stroke letter in October 2002. The Canadian Risperdal stroke warnings cited 37 reports of Risperdal stroke or Risperdal stroke-like events, including 16 deaths. Physicians in the United States were not warned until another 5 months had passed.

In addition, a significantly higher incidence of cerebrovascular adverse events was seen in patients treated with Risperdal compared with those treated with placebo. This label update was based on data from a study of 1,230 patients with dementia in four placebo-controlled trials conducted in elderly patients with dementia. Janssen emphasized in the letter that Risperdal is not indicated for the treatment of dementia.

The implications that Risperdal stroke occurrences are more likely to occur should result in a higher accountability for prescribing Risperdal.

Many patients are concerned that Johnson and Johnson is not promptly warning the FDA and/or their physicians of serious events such as Risperdal strokes over concerns that safety warnings will hurt sales.

The result of a Risperdal stroke can affect the entire body. Depending on the severity of the Risperdal stroke paralysis, cognitive effects, emotional problems, speech difficulties, loss of mobility, in addition to other adverse effects could be suffered. If you or a loved one has taken Risperdal and have suffered a Risperdal stroke or any other Risperdal side effect, then please contact our attorneys who can assist you with asserting your legal rights and seeking recovery for the injuries you have suffered.

For more information: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm152291.htm

Labels: Black box label, Canada, dementia, Risperdal, Stoke, stroke

The World Health Organization recommended that all children receive a vaccination against the rotavirus. Rotavirus is a leading cause of diarrhea which kills more than 500,000 children worldwide each year. The virus includes vomiting and diarrhea, in infants and young children, and is highly contagious. An estimated 1,600 children under the age of 5 are killed by this infection, every day, with more than 85 percent of the deaths occurring in Africa and Asia.

Dr. Paul, Offit, chief of infectious diseases at Children’s Hospital of Philadelphia and co- inventor of one of the rotavirus vaccines manufactured by Merck & Company, said “by immunizing half the children in the United States the incidents of disease will be reduced by 80 to 90 percent”.

The first vaccine developed to fight rotavirus, sold by Wyeth, was pulled from the market in 1999 after it was linked to a life-threatening type of bowel obstruction, known as intussusception. According to Merck and Company their vaccine called Rotarix, does not have this problem. Merck and Company conducted a study of more than 63,000 infants. In that study, there were no increased risks of intussusception in those who received Rotarix compared to those who received placebo. The FDA has approved the vaccine and it is currently being used to immunize children. However, the FDA has requested that the manufacturer conduct post- marketing safety studies involving more than 40,000 infants to provide additional safety information.

For more information see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116875.htm

Labels: children, david carradine; rotavirus, diarrhea, infectious diseases, vaccine

News reports just updated with information that the Brazilian Air Force announced that the debris found earlier this week in the Atlantic Ocean was not actually from the missing Air France Flight 447. On Tuesday, debris and oil slicks were found in an area of the Atlantic Ocean that the plane would have flown over. Brig. Ramon Borges Cardoso told reporters that the oil slicks found could not have been from the plane because the quantity of oil found was more than the plane was holding. Additionally, the debris, including wooden pallets and air plane seats, was also identified as not being from Flight 447.

This announcement sends investigators back to square one in discovering what actually happened to Flight 447. As mentioned previously in the blog, the crew of Flight 447 did not make any communications indicating that there were any problems with the plane at any time before the plane just disappeared off of radar, only 3 hours into the 11 hour flight. Officials say that foul play has not been ruled out. There were 228 people on the flight, including 3 from the United States. A public interfaith service was held for the passengers and crew early Thursday in Rio de Janeiro.

For more information, see CNN and FoxNews websites:

http://www.cnn.com/2009/WORLD/americas/06/05/brazil.plane.crash/index.html

http://www.foxnews.com/story/0,2933,525181,00.html

The FDA announced today that it has approved the first cancer drug specifically to be used for dogs. The drug is called Palladia and is manufactured by Pfizer. The drug is used to treat skin based mast tumors. This type of tumor accounts for 20% of all skin based cancers in dogs. While many mast tumors can appear to be small and benign, they can be a deadly form of cancer in dogs. Some mast tumors can be removed very easily, but some cannot and can cause serious problems. Palladia works in two ways to attack mast tumors: it cuts off the blood supply to the tumor and it kills the tumor.

Until the development and approval of Palladia, all cancer drugs used in veterinary medicine were developed for use in humans and were used in an “extra-label” manner to treat cancer in dogs. When asked for her reaction to the approval of Palladia, DVM and PhD Bernadette Dunham said, “This cancer drug approval for dogs is an important step forward for veterinary medicine. Prior to this approval, veterinarians had to rely on human oncology drugs, without knowledge of how safe or effective they would be for dogs. Today’s approval offers dog owners, in consultation with their veterinarian, an option for treatment of their dog’s cancer.” Some common side effects of Palladia are diarrhea, decrease in or loss of appetite, lameness, weight loss, and blood in the stool.

For more information on Palladia, see the approval summary at:
http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/UCM164091.pdf

See the news article on the FDA website at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm164118.htm

Labels: animal, cancer, dog, DVM, FDA, Palladia, Pfizer, tumor, vet

Doctors are testing a new kind of obesity surgery that does not involve cuts or scars. Doctors place a tube that is as thick as a garden hose down the throat to snap staples into the stomach. The scar- free procedure creates a narrow passage that slows the food as it moves from the upper stomach into the lower stomach, helping patients feel full more quickly and eat less.

The testing has been done on about 200 U.S. patients and 100 patients in Europe. After about 18 months, obese European patients have lost an average of about 45 percent of their body weight, said Dr. Gregg Nishi, a surgeon at Cedars- Sinai Medical Center in Los Angeles.

While the two studies are still under way and only brief details are being released, Nishi said results “so far are slightly better than typical results with conventional stomach stapling.”

Lilliana Gomez, an administrative coordinator at Cedars-Sinai, was among the first Americans to have this scarless obesity surgery last year. Since her operation in August, she has lost about 40 pounds and dropped from a size 22 to a size 16. Gomez previously considered a gastric bypass operation, which is a more complex kind of stomach stapling that reduces the stomach to the size of a golf ball and reroutes the digestive tract. Gastric bypass is far more invasive and increases chances of malnutrition because it repositions how the stomach attaches to the intestines to restrict calorie absorption.

The new scarless obesity surgery is part of a new medical movement to perform surgery through body openings such as the nose, mouth, and vagina instead of making cuts. The idea is to reduce the chances of infections and pain, and to speed recovery. Further, since there are no scars, there are cosmetic advantages as well.

Side effects have been mild and include: perforation of the esophagus, sore throat, nausea and some abdominal pain.

Labels: Cedars-Sinai, gastric bypass sugery, obama cairo speech, obesity, scar-free surgery

Risperdal is a medication manufactured by Johnson & Johnson to treat schizophrenia in adults and adolescents ages 13-17 years old. Risperdal is also prescribed to treat manic-depressive disorders, autism, Asperger's syndrome, Tourette's Snydrome, ADD, and paranoia. Risperdal has been approved by the FDA. See http://www.risperdal.com/risperdal/shared/pi/risperdal.pdf. This drug, however, is associated with a number of adverse health effects, including an alarming condition known as gynecomastia or male breast growth. The drug works by blocking dopamine, which releases prolactin from the pituitary gland. This, in turn creates a sedating effect on the patient. Some young boys who have taken Risperdal have suffered the humuliating effect of developing breasts. Risperal's label does not provide consumers with appropriate warnings about the life changing effect of breast development, which necessarily requires corrective surgery. Some young boys who have taken Risperdal have suffered the humuliating effect of developing breasts. Examples of these incidents can be found at the following sites:
http://www.3news.co.nz/ADHD-drug-leads-to-breast-development-in-Kiwi-male/tabid/420/articleID/106534/cat/58/Default.aspx; http://tmap.wordpress.com/2009/05/26/risperdal/. If you or a love one have been diagnosed with gynecomastia following use of Risperdal, then contact our attorneys who can assist you with asserting your legal rights and seeking recovery for the injuries you have suffered.

Labels: Catcher in the Rye, copyright, Holden Caulfied, J.D. Salinger, New York, Spielberg, Weinstein

The Food and Drug Administration is weighing whether patients’ course of treatment for the widely used cancer drug Rituxan should be changed. Rituxan may pose less of a risk of developing progressive multifocal leukoencephalitis (PML) if it is used for a shorter period or with breaks, according the FDA and the Wall Street Journal.

The drug is co-marketed by biotechnology companies Genentech Inc. of California and Biogen Idec Inc. of Massachusetts. Rituxan, which is used to treat lymphoma, a cancer of immune-system cells, had $2.6 billion in U.S. sales in 2008.

PML is a viral infection that affects the white matter of the brain. PML is caused by reactivated JC virus. Latent JC virus is present in about 80 percent of adults. Patients with PML exhibit neurological symptoms like confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems. PML gets worse over time, and is usually fatal. There is no treatment or cure for the disease. It is often associated with drugs that suppress the immune system.

A study released in March in the medical journal, Blood linked Rituxan to 57 cases of PML between 1997 and 2008. Of 57, 51 died. The median time between their diagnosis and death was about two months.

The study’s researcher commented: "The potential contribution of Rituxan to the development of PML is unknown; however, it cannot be excluded."

While Rituxan has been linked to a higher number of PML cases, some are not calling for a recall of Rituxan because it is frequently the best option for patients with life-threatening cancer. It is questionable whether the drug should be used in patients who do not have life-threatening diseases. There are typically more options for patients with rheumatoid arthritis, another ailment which Rituxan is approved to treat.

Doctors say Rituxan is also used "off label" for conditions not approved by the FDA, including lupus and psoriasis. FDA officials said they are aware of some off-label uses, which are legal so long as the drug maker does not promote them. Genentech said it doesn't promote off-label use of Rituxan.

Doctors at the FDA have been looking at the long-term uninterrupted use of Rituxan as a potential factor in PML. By suppressing the immune system, the drug may give free rein to the virus, normally under check, that causes the brain disease.

"We've had discussions at the FDA about whether drug holidays or limitations on the duration of therapy might reduce the risk of PML and other serious adverse effects of chronic immunosuppression," said John Jenkins, director of the FDA's drug approval section.

Drug holidays themselves can cause problems, though. "Sometimes [after a break from the drug], the disease recurs more severely and requires higher doses to bring the disease back under control," Dr. Jenkins said.

The FDA warned of the possible link between Rituxan and PML in 2006. Currently, Rituxan's label has a "black box" warning about PML, the strongest possible warning.



Reports of adverse events associated with Rituxan, including PML, should be reported to the FDA.



The 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/ucm109106.htm

http://online.wsj.com/article/SB124381351149970563.html

Labels: Air France crash update, cancer, death, FDA, national running day, PML, rituxan, Wall Street Journal

China has recently introduced an electronic smoke- free cigarette (“e-cigarette”). The battery-powered device, which can be bought online, delivers an odorless dose of nicotine and flavoring without tar or additives, and produces a vapor mist that is nearly identical in appearance to tobacco smoke. Because they do not produce smoke, these cigarettes can be used in workplaces, restaurants, and airports.

The electronic cigarettes have not been approved by the government, and are virtually unstudied. In fact, the Food and Drug Administration (“FDA”) has already refused entry to dozens of shipments of e-cigarettes. “These appear to be unapproved drug device products, and as unapproved products they cannot enter the United States” said Karen Riley, a spokeswoman for the FDA.

However, it appears that e-cigarettes have made their way into the country. One Rhode Island man, who quit smoking regular cigarettes last year, likes e-cigarettes so much that he has stated selling them at a mall kiosk. For about $100 to $150, a user can buy a starter kit including a battery-powered cigarette and replaceable cartridge that typically contains nicotine flavoring and propylene glycol, a liquid whose vaporizing produces a smoke-like mist. When a user inhales, a sensor heats the cartridge. The flavorings include tobacco, Menthol and cherry, and the level of nicotine varies by cartridge.

For more information see: http://www.smoking-everywhere.com/

Labels: Air France crash update, electronic cigarette, FDA

It has been recently reported that what appear to be pieces of the Air France Airbus 330 jet that disappeared early Monday have been found in the Atlantic Ocean. Some objects and seats were spotted floating off of the island of Fernando de Noronha about 220 miles off of the coast of Brazil. Experts say that the wreckage is near what the flight path of the jet would have been.

Air France Flight 447, while carrying 228 people, encountered heavy turbulence and rains Monday shortly after it took off from Rio de Janeiro, Brazil. The plane was en route to Paris, France. Shortly after the plane encountered turbulence, its automatic system sent a series of messages to the company’s maintenance computers, informing them that “several pieces of aircraft equipment were at fault or had broken down.” Right around that same time, the jet went off radar. The jet also sent a message that it had lost pressure. The last known contact that the jet had with air traffic control was at 2:33 a.m. Monday morning. The jet was asked to check in again at 3:20 a.m., but it never did. A search was launched by the Brazilian air force 3 hours later. The plane was 4 years old and it had last had maintenance done to it on April 16. There is speculation that lightening struck the plane, which caused the plane problems, although a statistic from 2001 states that lightening hits every plane about once a year, almost always causing no problems.

For more information, see the article on CNN:
http://www.cnn.com/2009/WORLD/americas/06/02/brazil.france.plane.missing/index.html

Also, see an article from the Wall Street Journal
http://www.cnn.com/2009/WORLD/americas/06/02/brazil.france.plane.missing/index.html

Labels: Air France, Brazil, crash, Flight 447, jet, Plane Seat Cushion

If you took a prescription pill recently, odds are it was generic: almost 70 percent of all prescriptions dispensed nationwide were generics in 2007. This totaled $58 billion in sales. Health care insurers see generics as an easy way to cut costs. Pharmacists in most states can freely give patients whichever version of a drug is cheapest, without telling the prescribing doctor; in some states, pharmacies are required to make this switch. And few of us complain when it happens: People who wouldn't dream of substituting Diet Pepsi for Diet Coke, simply because of the taste, eagerly swap vital medications, because the change can cut co-pays in half.

When you fill a prescription, you expect to get the medication your doctor ordered. But pharmacists can legally give different versions of a drug without your knowledge and the consequences can be dire.

This is of special concern to epilepsy patients because doctors and patients spend much time fine-tuning the precise cocktail of medications the keep the seizures at bay. However, a generic may not work exactly like its brand-name counterpart, throwing off the precision in medications. One patient suffered a seizure shortly after her pharmacists unknowingly switched her medication. The consequences could have been graver had she been driving her car instead of her bicycle. As it was, when she fell off the bike, she suffered a broken leg, and a hairline fracture in her left eye socket.

Pharmacists commonly practice "therapeutic substitution," where the pharmacist legally switches a drug prescribed by the physician — but without telling the patient or the physician. Usually, pharmacists replace a brand-name drug with a generic formulation of the exact same medication. Therapeutic substitution is similar but with one crucial distinction: The new drug is in the same class as the old and treats the same condition, but it's not precisely the same medication.

Many lawmakers and health-policy experts say the trend of prescribing generics has little downside. "Generic drugs have the same active ingredient that brand-name drugs do and are made in FDA-approved plants, just as brand-name drugs are," says Aaron S. Kesselheim, M.D., an instructor in medicine at Harvard Medical School in Boston. In an analysis recently published in The Journal of the American Medical Association, Dr. Kesselheim reviewed data from 47 clinical studies and found no evidence that patients on brand-name cardiovascular drugs had clinical outcomes superior to those on generics.

While the dosage may be the same, the drug’s release formula can make a crucial difference. Release formulas, which control how quickly a drug dissolves in your bloodstream, are something drug companies carefully develop and patent. And these release-formula patents often remain in place after the patent on a drug's active ingredient has expired. That means generic companies must sometimes engineer their own release mechanism, as happened in the case of Budeprion XL 300 mg pill. Budeprion XL likely has a different release formula than its brand named counterpart. After patients and physicans made complaints to the FDA, it concluded in a 2008 report that patients' problems were more likely caused by normal relapses of depression than by differences in the drugs. But the report in question and the original approval of Budeprion XL’s 300 mg pill were based solely on data Teva, Budeprion XL’s manufacturer, had submitted for the 150 mg pill; the agency's judgment was that the doses were proportional and would behave similarly in the body. "Neither the FDA nor Teva did the required bioequivalence studies for this pill," counters Tod Cooperman, M.D., president of ConsumerLab.com.

Physicians' groups, including the American Academy of Neurology in St. Paul, Minnesota; the American Heart Association in Dallas; and the Endocrine Society in Chevy Chase, Maryland — all of whose members prescribe drugs that require delicate dosing — have warned doctors to look out for reactions to generics. They've also called on the FDA to study the issue in more detail.

There are ways to keep therapeutic substitution from happening to you. If your physician believes her drug of choice should not be switched for another, ask her to write "medically necessary," "may not substitute," or "DAW" — for "dispense as written" — on the prescription. That obligates the pharmacist to check with you and your physician before making any switches.

For more information please see:

http://www.sciencedaily.com/releases/2001/08/010829083837.htm
http://www.msnbc.msn.com/id/30940044//
http://www.msnbc.msn.com/id/30627962/

Labels: American Academy of Neurology, Generic, Pharmacy, Substitute, Walgreen

Labels: Disney World, Disneyland, kylie ellis, traumatic brain injury

Recently on May 18, Generic drug maker Ranbaxy Laboratories filed a corrective action plan to take steps to rectify the current FDA ban on some of its generic drugs and allegations falsifying new drug applications. In September of 2008, the FDA barred some of Ranbaxy's drugs from import to the U.S because of violations found during inspections of the Dewas and Paonta Sahib Facilities in India. The Paonta Sahib plant was cited in February of 2009 for falsifying data on new and approved drug applications.

While the details of the corrective plan have not been released, “The FDA is working very closely with the firm to ensure that all the Ranbaxy products currently in the U.S. market are safe and effective,” FDA spokesman Christopher Kelly said in an e-mail to Bloomberg.com yesterday. “The next steps will be dependent on the actions identified” in the plan, he said. A corrective plan of action includes, but is not limited to, conducting a third-party independent audit of applications associated with Paonta Sahib.

Based in India and operating in the United States since 1995, Ranbaxy is one of the 10 largest generic-drug producers in the world. Several scandals have surround Ranbaxy this past year. In July of 2008, US prosecutors alleged that Ranbaxy forged documents relating to an investigation into the quality of the company’s drugs sold in the United States. Allegations included that Ranbaxy concealed violations of good manufacturing practice regulations from FDA and made weak or adulterated HIV drugs dispensed in Africa.

In February the FDA also said the plant in Paonta Sahib falsified data and test results in approved and pending drug applications. An inspection in 2006 revealed the problem which included incorrectly storing drug samples in refrigerators though stability testing required the drugs be stored at room temperature. Logbooks even did not identify which samples were in the refrigerator or how long they had been there.

To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility. The AIP is invoked when a company's actions raise significant questions about the integrity of data in drug applications. This AIP covers applications that rely on data generated by the Paonta Sahib facility only.

The FDA halted the review of drug applications made at Ranbaxy’s Paonta Sahib plant in India because of the issue. To date, the FDA has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.

The affected applications are for drugs that fall into three categories:

• Approved drugs made at the Paonta Sahib site for the U.S. market;
• Drugs pending approval at the FDA that are not yet marketed; and
• Certain drugs manufactured in the United States that relied on data from the Paonta Sahib facility.

In the meantime, the FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Individuals who are concerned about their medications should talk with their health care professional.

For more information:

• For drug safety information, read: FDA's Drug Safety Initiative
• Read the FDA's 2008 Warning Letters to Ranbaxy and the Import Alert
• Read the redacted AIP letter to Ranbaxy
• Read about the Application Integrity Policy
• Read the FDA’s News Release announcing Ranbaxy Paonta Sahib AIP

Labels: ban, corrective, FDA, Generic, Ranbaxy, tonight show

Doctors in Italy have issued a warning about of the risks of teens consuming caffeinated chewing gum. The warning was prompted after a 13-year-old boy was hospitalized with caffeine intoxication after chewing two packs of stimulant gum. The packs contained around 320 milligrams of caffeine which he ingested within a four-hour period. The boy’s parents noticed that he was acting aggressive and agitated. He also complained of abdominal cramps, increased and painful urination, and prickling sensations in his legs. When doctors examined the boy, they found that his heart rate, respiration, and blood pressure were irregular.

The boy, who was medically monitored periodically, showed side effects following the use of the gum. He experienced sinus bradycardia, low left-ventricular ejection fraction, and was sleepy and sluggish for days.

It is unclear what type of gum the boy used, however there are a variety of brands offered including Jolt, Kickbrix, Penguin, and Blitz which contain caffeine. These gums compete with energy drinks and shots that are available for purchase regardless of age.

It is important for parents to remember that experts recommend that teens not consume caffeinated products after noon, and sleep at least nine hours a night. Since teens often stay up late using the internet, or texting, use of caffeinated products become more tempting to them. While teen's body clocks may force them to stay up somewhat later than adults, and wake up later too, it's still important for adults to convey the message that nighttime is the time to start slowing down.

Labels: caffine, gum, Kimora Lee Simmons, teens, texting, Twitter

We have previously posted about some of the dangers of the Yaz birth control pill. Even more information has come out since. Yaz has recently been under heavy scrutiny for possible dangerous side effects such as stroke, pulmonary embolism, and deep vein thrombosis (DVT). Additionally, the FDA and many states’ attorney general have been on Yaz’ case for a different problem: misleading advertising.

The first time Yaz was admonished for misleading the public was through an FDA warning letter in 2003. The letter was in regards to misleading ads that stated that Yaz was “unique” because it contained progestin drospirenone, therefore leading people to believe that Yaz was superior to other birth control pills. Then in 2008, the FDA sent another warning letter concerning two separate television commercials that publicized treatments for which Yaz was not approved. In February of 2009, attorney generals from 27 different states reached a settlement with Yaz to correct misleading information that Yaz put in tv ads that suggested that Yaz was approved for the treatment of PMS and acne. As a result, Yaz is now required to get FDA approval for all ads before they can air on tv.

Yaz was first released in May 2001 and has since become one of the best selling oral contraceptives, with sales over $616 million in 2008. Neither the FDA nor the manufacturer, Bayer, have yet to recall the drug for its serious side effects. Many of the people that take Yaz may have been induced to take it through Yaz’s misleading advertising, and in turn, suffering serious side effects.

For more information, see:
The FDA’s warning letter concerning Yaz:
http://origin.www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053993.pdf

Wall Street Journal article concerning new ad campaign:
http://www.nytimes.com/2009/02/11/business/11pill.html

Labels: advertising, Air France, birth control, DVT, FDA, NCAA, stroke, Susan Boyle, YAZ