Monday, August 31, 2009

Diacetyl

Diacetyl is a compound often derived from natural sources that helps lend a buttery flavor to foods such as popcorn and other snack foods. Diacetyl is considered "Generally Recognized as Safe" by the FDA, but this classification only applies to ingesting the compound. Recent evidence suggests that, while Diacetyl is safe to eat as a flavoring, it can cause severe respiratory problems if inhaled. A serious disease known as Bronchiolitis Obliterans, or BO, has been linked to inhalation of Diacetyl.

If you or a loved one has been exposed to Diacetyl, and have suffered from respiratory symptoms, a consultation with the experienced pharmaceutical attorneys at Schlichter, Bogard & Denton can help you determine if you might be eligible for damages.

Who is in Danger of Developing Bronchiolitis Obliterans?
BO is a rare disorder, but is seen in people who work in popcorn factories at a significantly higher level than in the general population. BO is often misdiagnosed as another lung ailment such as asthma, bronchitis or pneumonia, but its long-term effects are serious and irreversible.

Symptoms of BO include:

  • Wheezing
  • Shortness of breath
  • Dry, persistent cough


Workers in the popcorn industry most likely to develop BO are those who are most extensively exposed to Diacetyl. These include those who mix flavors and those who test the product by popping multiple bags of popcorn.

If you have been exposed to Diacetyl at your workplace and believe you might be suffering from Bronchiolitis Obliterans, please contact nationwide pharmaceutical injury attorneys Schlichter, Bogard & Denton to schedule a free initial consultation.

posted by Erica at 12:37 PM

Tuesday, August 25, 2009

Yaz® and Yasmin®

Yaz and Yasmin are both popular birth control pills made by Bayer. While widely prescribed for pregnancy prevention as well as other hormonally related issues, such as PMS, acne, and bloating, these pills have only been FDA approved for pregnancy prevention and treatment of PMDD.

Unfortunately, Yaz and Yasmin also carry possible dangers. One of their major ingredients, known as drospirenone, can cause an increase in potassium levels in the bloodstream. In some cases, this can lead to serious side effects, and can even be fatal.

Who Should Avoid Yaz and Yasmin?
Particularly susceptible to these side effects are people who have existing problems with their kidneys, liver, or adrenal glands. Increases in potassium levels can be very dangerous in these cases. In addition, some other common medications can also increase potassium levels in the bloodstream. Combined with Yaz or Yasmin, the effects can be extremely serious.

What are the Possible Side Effects?
Some possible side effects of Yaz or Yasmin include:

  • Deep vein thrombosis
  • Pulmonary Embolism
  • Heart attack or cardiac related problems
  • Stroke
  • Sudden death
  • Damage to the kidneys
  • Gallbladder removal


If you have any concerns about using Yaz or Yasmin and how they might interact with drugs you're already taking or how they might affect existing medical conditions, consult with your doctor. Your doctor can check your blood potassium levels after you have taken Yasmin to determine if the levels are abnormal.

If you or a loved one have suffered from any of the above side effects and suspect Yaz or Yasmin might be the cause, please contact one of the experienced, nationwide pharmaceutical injury attorneys at Schlichter, Bogard & Denton. If you have been hurt by dangerous pharmaceutical side effects, we want to help.

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posted by Erica at 12:34 PM

Thursday, August 20, 2009

Certain Popular Nutritional Supplements May be Dangerous

The Food and Drug Administration (FDA) recently announced to consumers that certain nutritional supplements (often popular with athletes) may actually contain steroids or substances like steroids that can cause liver disease and kidney failure. The FDA has received a number of reports (mostly from men) of medical problems after use of the nutritional supplements. The FDA said there are eight specific supplements, all sold by the same company, which have been linked to illness.

Consumers are warned to avoid using body-building products to claim to enhance or diminish the effects of hormones. There are certain code words these products often have on their labels; users of these supplements typically know which words to look for:

  • Anabolic
  • Gyno (referring to gynecomastia, which is a condition characterized by large breasts in males)
  • Tren
  • Estrogen-blocker
  • Blocks hormones
  • Minimizes gyno (again, referring to gynecomastia)


The FDA added that buyers should avoid products claiming to diminish or enhance the effects of hormones such as estrogen, testosterone, or progestin.

Other than provide general guidance and name eight specific products, the FDA has not been able to offer more because they admit they don't know how many products the warning will ultimately affect. They believe there may be a number of firms with like products, or even products that are exactly the same as the ones that the FDA has already taken action against.

Companies who market dietary supplements do not have to prove the drugs are effective or safe before the FDA approves it for sale. The industry is largely self-regulating and is responsible for making claims about safety and effectiveness, as well as voluntarily recalling them if there are problems with little oversight.

The FDA has received at least 15 reports over the last two years of serious health problems related to taking body building products.

If you have been harmed by one of these dangerous supplements, please contact the attorneys at Schlichter, Bogard & Denton today.

posted by Erica at 12:52 PM

Friday, August 14, 2009

Birth Control Pills Linked to Increase in Blood Clots

Yaz and Yasmin are popular birth control pills that differ only in dose. These drugs are referred to as "fourth generation" birth control pills; they contain a new type of synthetic progestin called "drospirenone." For many years now, these two pills have been prescribed to prevent pregnancy and to reduce water retention and bloating, two of the most common symptoms of Premenstrual Dysphoric Disorder (PMDD), a condition millions of women suffer from each time they get their menstrual cycle. The Food and Drug Administration has announced that Yaz and Yasmin raise the level of potassium in your blood to a dangerous level. Increased serum potassium levels can lead to:

  • Stroke
  • Heart attack
  • Pancreatitis
  • Blood clots in the legs (DVT—deep vein thrombosis)
  • Blood clots in the lungs (pulmonary embolism)
  • Gall bladder disease



Increased risk of blood clots?

Two recent studies have found significantly increased risks associated with Yaz and Yasmin over other types of birth control pills. The first assessed the risk of venous thrombosis (blood clots) in women who take hormonal contraception was conducted on women ages 15-49 with no history of heart disease or any other malignant disease. The study found that of the 3.3 million women taking oral contraceptives, there were 4,213 venous thrombotic events. Of those, 2,045 occurred in women currently taking oral contraceptives.

The study found that oral contraceptives containing drospirenone, such as Yaz and Yasmin, were associated with a much higher risk of venous thrombosis than traditional oral contraceptives, which contain levonorgestrel rather than drospirenone. To read the full study, click here.

The second study found that Yaz and Yazmin users have twice the risk of a clotting event than users of birth control pills that contain levonorgestral. To read this study, click here.

At the time of this writing, the FDA has received 50 reports of death associated with Yaz and/or Yasmin during the four-year period 2004 to 2008. Women as young as 17 have died due to blood clots, stroke, and cardiac arrest. If you are taking either one of these birth control pills, you should contact your doctor immediately to discuss its safety.

Yaz and Yazmin are combination hormone contraceptives manufactured by Bayer Healthcare.

Schlichter, Bogard & Denton is a national leader in pharmaceutical litigation and is currently reviewing cases of women harmed by Yaz and Yazmin. The consequences of taking a dangerous drug can be devastating. We are prepared to handle the most complex dangerous drug cases, and we have successfully represented thousands of people all over the country in pharmaceutical litigation cases. We can help you, too.

Please contact the experienced pharmaceutical litigation attorneys at Schlichter, Bogard & Denton today. One of our attorneys will review your case and advise you of how best to proceed.

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posted by Erica at 12:39 PM

Friday, August 7, 2009

Dorel Expands Recall of Stair Gates Due to Fall Hazard

Importer Dorel Juvenile Group USA, of Columbus, Indiana just issued a recall of about 31,500 Safety 1st SmartLight Stair Gates, the U.S. Consumer Product Safety Commission (CPSC) just announced. Of note, 100,000 units were previously recalled in February 2009, the CPSC said.


The Safety 1st SmartLight Stair Gates were recalled because the hinges that hold the stair gate in place can break, posing a fall hazard to children if the gate is placed at the top of the stairs. To date, no injuries or incidents have been reported.

The recall involves the Safety 1st SmartLight Stair Gate, which was manufactured in China, with model number 42111, which is printed on a sticker under the handle panel. The gates, which were manufactured before December 20, 2008, are white metal with a gray handle and a motion sensor nightlight that illuminates on approach. The manufacture date is located below the gate's handle as a date wheel imprinted in the plastic; an arrow indicates the month, and the year is stamped inside the circle. The manufacture date is also printed on a sticker inside the battery door.

The recalled Safety 1st SmartLight Stair Gate was sold at mass merchandise and juvenile product stores nationwide, including Babies R Us, Toys R Us, Wal-Mart.com and other online retailers from January 2005 through July 2009 for about $60.

The CPSC is advising consumer to stop using the recalled gate and contact the company to obtain a free repair kit. Consumers can call Dorel Juvenile Group toll-free at 1-866-690-2540 Monday through Friday from 8:00 a.m. to 4:30 p.m. Eastern Time; complete an online order form on the Dorel Juvenile Group Web site at www.djgusa.com/safety_notice/ to obtain their free repair kit; email the company at Smartlightgate@djgusa.com, or send a fax to 1-800-207-8182. Consumers should not return the stair gates to retail stores.

For more information please see: http://www.cpsc.gov/cpscpub/prerel/prhtml09/09117.html

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posted by Jessica at 2:24 PM

Plaintiffs Petition for Creation of MDL in Yaz

Currently, 32 complaints have been filed in federal court against the manufacturers of Yaz. Plaintiffs have alleged physical injuries as a result of Yaz use such as deep vein thrombosis, pulmonary embolism, heart attack, stroke, kidney failure, seizures, gall bladder injuries, and death. The federal plaintiffs have filed suit in various federal forums and have recently petitioned the Northern District of Ohio for a consolidation of all of the suits for Multi-District Litigation (MDL).

An MDL is the consolidation of all similar federal cases for pre-trial purposes. An MDL can be established when there are extremely similar claims against the same defendants and all of the claims have similar issues that will be litigated. MDLs are very efficient especially in a discovery sense because documents generally will only have to be produced once for every plaintiff that is involved in the MDL. Plaintiffs requested that the MDL for Yaz be established in the Northern District of Ohio because there are currently 14 of the 32 federal suits filed in that district. Plaintiffs argue that the Northern District of Ohio is a centralized location and will be the most convenient location for an MDL, given that most of the cases filed are already in the Northern District of Ohio.

See the Petition for the creation of an MDL at:

http://www.jpml.uscourts.gov/_Mats/WinMATS%20Pleadings/2100/MDL%202100%20Pleading%201.pdf

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posted by Colleen at 12:48 PM

Recent College Graduate Sues Alma Mater Because She Hasn’t Found a Job

A recent college graduate from New York’s Monroe College is suing her alma mater for $72,000, because she cannot find a job. Trina Thompson, 27, of Bronx, New York, graduated from Monroe College in April with a bachelor of business administration degree in information technology.

On July 24, she filed suit against the college in Bronx Supreme Court, alleging that Monroe’s “Office of Career Advancement did not help [her] with full-time job placement.” In her complaint, Thompson seeks $70,000 in reimbursement for her tuition and $2,000 to compensate “for the stress of her three month job search.”

According to Thompson, any reasonable employer would pounce on an applicant with her academic credentials, which include a 2.7 grade-point average and a solid attendance record. Thompson says that she has fulfilled her end of the job-search bargain by posting her cover letter and resume on Monroe’s Career Services website. However, she contends that Monroe has not done their part. “They’re supposed to say, I got this student her attendance is good, her GPA is all right. Can you interview this person? They’re not doing that,” she said.

She suggests that Monroe’s Office of Career Advancement shows preferential treatment to students with excellent grades stating, “They favor more toward students that got a 4.0. They help them more out with the job placement.”

Monroe College released a statement saying that “while it is clear that no college, especially in this economy can guarantee employment, Monroe College remains committed to working with all its students, including Ms. Thompson, who graduated only three months ago, to prepare them for careers and to support them during their job search.”

For more information see: http://www.cnn.com/2009/US/08/03/new.york.jobless.graduate/index.html?eref=rss_topstories

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posted by Chavon Williams at 12:41 PM

Women in Cameroon Found to Have New Gorilla Strain of HIV

A new strain of the virus that causes AIDS has been discovered in a woman from the African nation, Cameroon. This strain differs from the three known strains of human immunodeficiency virus (HIV) and appears to be closely related to a form of simian virus recently discovered in wild gorillas, researchers reported in Monday’s edition of the journal Nature Medicine.

One of the researchers, Jean-Christophe Plantier of the University of Rouen, in France, noted that the finding “highlights the continuing need to watch closely for the emergence of new HIV variants, particularly in western-central Africa.”

According to researchers, the most likely explanation for the new HIV virus strain is gorilla-to human transmission. But they added that they cannot rule out the possibility that the new strain started in chimpanzees and moved into gorillas and then humans, or moved directly from chimpanzees to both gorillas and humans.

“Findings like these remind us that primates continue to transmit viruses to humans just as they did before we knew about AIDS,” said Rowena Johnston, Vice President of research for the Foundation for AIDS in New York City. “HIV continues to broadside us from directions we do not necessarily expect.”

The 62-year-old Cameroon woman tested positive for HIV in 2004, shortly after moving to Paris from Cameroon, according to researchers. She lived near Yaounde, the capital of Cameroon, but said she had no contact with apes or bush meat, a name often given to meat from wild animals in tropical counties. HIV can be passed through blood as people eat bush meat.
Researchers have yet to determine how wide-spread the new HIV strain is. However, the virus’ rapid replication indicates that it has adapted to human cells.

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posted by Chavon Williams at 12:37 PM

Thursday, August 6, 2009

New Organ Transplant Process Almost Eliminates Chances of Rejecting the Organ

Surgeons in two Washington, D.C. area hospitals have performed seven kidney transplants involving 14 donors and recipients that did not have matching antibodies, using a process that almost completely eliminates the chances of a recipient’s immune system rejecting the organ. The process, plasmapheresis, is the use of a machine to remove antibodies from a person’s blood that can cause an organ rejection.

Doctors predict that through the use of this process, racial and ethnic groups that are typically underserved in organ donation will have a better chance of receiving an organ. For example, there are currently 80,000 people on the kidney transplant waiting list in the United States. Of those, 36% are African-American, but only 15% of living donor kidneys go to African-Americans. Doctors say that the discrepancy is caused by the lack of suitable matching organs. As a rule, people are more genetically similar and therefore better organ transplant match-ups, if they are from the same racial or ethnic group.

Although minorities donate organs at rate proportionate to other ethnic groups, they also have greater needs for transplants because of diseases that are more prevalent in particular ethnic or racial groups. For example, African-Americans, Asian and Pacific Islanders, and Latinos are three times more likely than Caucasians to have kidney disease, the Health Department says. Through the use of plasmapheresis, doctors hope that the chances of a racial minority receiving a life-saving organ will increase.

For more information, see the CNN article at:
http://www.cnn.com/2009/HEALTH/08/05/kidney.transplant.plasmapheresis/index.html?eref=rss_health

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posted by Colleen at 12:25 PM

Wednesday, August 5, 2009

Researchers produce mice from skin cells


Scientists at The Scripps Research Institute have created healthy adult mice out of mouse skin cells.

The study, published in Nature, showed that adult cells can be reprogrammed backward in their development, until they have the characteristics of embryonic stem cells.


Observers said it was remarkable and promising news for the future of stem cell research.

Researchers hope that the Study’s results ultimately lead to the ability to treat diabetes, Alzheimer's, Parkinson's, hearing loss, or spinal cord damage with a patient's own cells. It is preferable to use the patient’s own cells over another’s cells because of the risk of rejection.

Researchers estimate that these treatments are at least 15 to 20 years away.


Reprogramming mouse skin cells to grow into complete mice required a decade's worth of advances in mouse genetics, genetic engineering, stem cell biology and reproductive technology.

Today, the skin-derived mice continue to live in air-conditioned comfort in La Jolla.


http://www.nature.com/stemcells/2007/0706/070607/full/stemcells.2007.6.html

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posted by Jessica at 9:44 AM

FDA Rejects Savient’s Gout Drug

UPDATE: The FDA in a surprise decision declined to approve, Krystexxa, a gout drug manufactured by Savient Pharmaceuticals of East Brunswick, NJ.

The FDA declined the drug’s approval despite receiving a 14-1 recommendation for approval by its advisory committee in June. Generally, the FDA follows the recommendations of its advisory committees.

Savient plans to resubmit its application for approval Krystexxa early next year.

The FDA’s decision seems to be based on the drugs manufacturing process and not based on its effectiveness, according Savient’s press release.

The agency also concluded that a proposed change in the manufacturing process might make the drug sold to consumers different from the experimental drug tested in the clinical trial.

In addition, the FDA also said that Savient would need to have a program to monitor and reduce the side effects of the drug, particularly allergic reactions and cardiovascular problems.

Krystexxa was developed to treat gout, which is a painful form of arthritis. Gout is increasing because of richer diets, obesity and the aging of society.

The FDA typically does not discuss such regulatory decisions.

For more information please see:

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posted by Jessica at 9:27 AM

FDA Requires New Warning for TNF Blockers

The FDA announced yesterday that it had completed its review of tumor necrosis factor (TNF) blockers and that it had concluded that there is an increased risk of cancer in children and adolescents who use TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but it does not specifically mention leukemia. TNF blockers are approved for the treatment of multiple immune system diseases including Crohn’s disease, rheumatoid arthritis, psoriatic arthirtis, plaque psoriasis, and juvenile idiopathic arthritis.

When a person suffers from chronic inflammatory diseases, such as the ones listed above, their body overproduces a protein called tumor necrosis factor-alpha (TNF-a). When this protein exists in large quantities in the body, it can cause inflammation and damage to bones, cartilage, and tissue. When patients suffering from chronic inflammatory diseases take TNF blockers, the drug targets the overproduced TNF-a and neutralizes it. Brand names of TNF blockers include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cinzia (cetolizumab pegol), and Simponi (golimumab).

The law firm of Schlichter, Bogard & Denton is currently investigating claims against the manufacturers of Remicade, Enbrel, and Humira. If you or a loved one has suffered adverse events from the above mentioned drugs, please contact an experienced pharmaceutical attorney at Schlichter, Bogard & Denton. We serve clients nationwide.

For more information, see the FDA Press Announcement at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175803.htm

See the MedWatch Safety Information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm175843.htm

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posted by Colleen at 8:07 AM

Botulinum Toxin Drugs Get New Black Box Warning

Last month, we reported that the FDA was requiring stronger warnings on four types of botulinum toxin drug products. The most popular of the drugs affected by the warning change is Botox, which is commonly used in the United States for the off-label use of smoothing wrinkles. The FDA announced yesterday that all four of the botulinum toxin drug products now have a black box warning label on them.

The new warning cautions that the toxin used in the drugs, which is a variant of the bacteria that causes botulism, can migrate from the injection site to other areas of the body and can potentially cause symptoms similar to those experienced from botulism. The migration has mostly been reported when children with cerebral palsy are treated with the drug for muscle spasticity, an off-label use of the drug. In those children, the migration can cause severe adverse effects such as trouble swallowing and trouble breathing. No serious adverse effects have been reported from migration when the drugs are used for dermatologic purposes.

The new labels also caution health professionals that the four different types of botulinum toxin drugs are not interchangeable, because the units to measure each of the drugs are different. To help reduce the potential for dosing errors, the drugs have changed their established drug names (their generic names).

For more information, see the FDA Press Release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175013.htm

See the Drug Safety Information for Patients and Providers at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174949.htm

See the update of Safety Review for Patients and Providers at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174959.htm

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posted by Colleen at 6:43 AM

Tuesday, August 4, 2009

Certain Popular Nutritional Supplements May be Dangerous

The Food and Drug Administration (FDA) recently announced to consumers that certain nutritional supplements (often popular with athletes) may actually contain steroids or substances like steroids that can cause liver disease and kidney failure. The FDA has received a number of reports (mostly from men) of medical problems after use of the nutritional supplements. The FDA said there are eight specific supplements, all sold by the same company, which have been linked to illness.

Consumers are warned to avoid using body-building products to claim to enhance or diminish the effects of hormones. There are certain code words these products often have on their labels; users of these supplements typically know which words to look for:

  • Anabolic
  • Gyno (referring to gynecomastia, which is a condition characterized by large breasts in males)
  • Tren
  • Estrogen-blocker
  • Blocks hormones
  • Minimizes gyno (again, referring to gynecomastia)


The FDA added that buyers should avoid products claiming to diminish or enhance the effects of hormones such as estrogen, testosterone, or progestin.

Other than provide general guidance and name eight specific products, the FDA has not been able to offer more because they admit they don't know how many products the warning will ultimately affect. They believe there may be a number of firms with like products, or even products that are exactly the same as the ones that the FDA has already taken action against.

Companies who market dietary supplements do not have to prove the drugs are effective or safe before the FDA approves it for sale. The industry is largely self-regulating and is responsible for making claims about safety and effectiveness, as well as voluntarily recalling them if there are problems with little oversight.

The FDA has received at least 15 reports over the last two years of serious health problems related to taking body building products.

If you or a loved one has become seriously ill as a result of taking body building supplements, please contact the experienced pharmaceutical liability attorneys at Schlichter, Bogard & Denton. We serve clients nationwide.

posted by Erica at 1:10 PM

Monday, August 3, 2009

FDA Approves New Type 2 Diabetes Drug

On Friday, the FDA approved a new drug, Onglyza, to treat Type 2 diabetes. Onglyza, a once-daily tablet for adults with Type 2 diabetes, is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a post-market study that will specifically evaluate cardiovascular safety in a higher risk population.

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Delaware.

For more information see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174780.htm

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posted by Chavon Williams at 1:20 PM

Teva Animal Health Inc. is Banned from Distributing Adulterated Veterinary Drugs

The FDA has filed for a consent decree of permanent injunction that prohibits Teva Animal Health Inc., from manufacturing and distributing adulterated veterinary drugs. The injunction will prevent the defendants from manufacturing and distributing veterinary drugs until they meet the current Good Manufacturing Practice (cGMP) standards and receive FDA approval.

“Good manufacturing practice standards are the backbone of product quality and the instrument on which the FDA relies most heavily for assurance that veterinary drug products are safe and effective,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine.

From 2007 and 2009, FDA inspections revealed significant cGMP violations at Teva Animal Health's facilities in St. Joseph, Mo.

Under the terms of the consent decree, Teva Animal Health will not be able to begin manufacturing and distributing veterinary drugs until adequate methods, facilities, and controls are established. In addition, an independent expert must inspect the facilities and procedures and certify that they comply with cGMP. Finally, the FDA will inspect Teva Animal Health's facilities as needed before authorizing the company to resume operations.

“The FDA will not tolerate the manufacture and distribution of adulterated animal drugs,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “Veterinarians and pet owners can be assured that the FDA will investigate and take regulatory actions against companies that produce animal drugs under conditions and controls that are inadequate to assure their safety and quality.”

If Teva Animal Health further violates the consent decree, they are subject to payments of $20,000 for each day the defendants fail to comply with any provision of the decree and an additional $25,000 for each shipment of veterinary drugs in violation of the decree, up to $7.5 million per year.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174880.htm

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posted by Jessica at 7:38 AM

EPA Issues New Administrative Order for Doe Run Cleanup

On Friday, the EPA issued modified orders to Doe Run, a St. Louis based company, for its efforts on cleaning up lead mine tailings in Leadwood, MO. The modified orders were in response to concerns from area residents about the work being done by Doe Run to clean up the site in Leadwood.

We have previously written about the community concern regarding Doe Run’s efforts to clean up the site. The community began to go public with their health and lead dust exposure concerns after sludge that was dumped on a mining site to initiate growth spilled onto a landowner’s property. Doe Run has been using sludge, partially treated sewage and animal bones, as fertilizer to begin vegetation growth on the tainted areas. The sludge that spilled onto a landowner’s property was a large amount of animal bones and other trash from a Farmington sale barn.

The EPA order mandates that Doe Run submit a new sludge management plan by August 21. The order also requires that Doe Run finish its work at Leadwood by Sept. 30, 2010. Also under the new administrative order, Doe Run is forbidden from using materials containing animal bones or carcasses at the site as fertilizer.

In 1992, the EPA declared six mine tailing piles in St. Francois County as part of a federal Superfund cleanup project. The piles are leftovers from historic lead mining in an area known as the “Old Lead Belt.” For more than a decade, Doe Run has led the cleanup efforts. In addition to Leadwood, other piles are located in Bonne Terre, Desloge, and Park Hills.


For more information, see the article at the St. Louis Post-Dispatch at:
http://www.stltoday.com/stltoday/news/stories.nsf/sciencemedicine/story/57FC3102B84A2F488625760500025FB2?OpenDocument

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posted by Colleen at 7:06 AM

iPhone may be Vulnerable to Hacker Attacks



At the Black Hat Conference in Las Vegas, security experts uncovered flaws in Apple Inc.’s iPhone, that they say hackers can exploit to take control of the phone. Security experts warned that iPhone users need to know that their device is not entirely secure and that Apple should try to repair the vulnerability as soon as possible.


Charlie Miller, a security analyst, and Collin Mulliner, a Ph.D. student at the Technical University of Berlin discovered a method for hacking the iPhone that lets hackers easily knock a victim’s iPhone off a carrier’s network. This hacker method prevents users from making calls, accessing the Internet and exchanging text messages. At the Conference, the two showed how a hacker can disconnect an iPhone from the cellular network by sending it a singly, maliciously crafted text message, a message which the victim never sees. The messages send bugs into the iPhone, and are used to crash parts of the software.


Miller says that messaging attacks are attractive, and are gong to become more common, because the underlying technology is a core phone feature that can’t be turned off. Security experts have successfully tested the hacks on iPhones running on networks of four carriers in Germany along with AT&T in the United States. They said that they believe the methods will work with iPhone carriers around the world.


Security experts say they warned Apple of the flaw in the middle of July, but that the company has not yet fixed the problem.

For more information see: http://www.msnbc.msn/com/id/32222633/ns/techonolgoy_and_science-security/

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posted by Chavon Williams at 7:02 AM

posted by Chavon Williams at 7:02 AM

Restrictive Diets may not be Appropriate for Children with Autism

A new study reveals that parents of autistic children who place their children on a strict gluten-free or diary-free diet, because they are convinced that gastrointestinal problems are an underlying cause of the disorder, may have done so unnecessarily.

Researchers at the Mayo Clinic reviewed medical records of over 100 autistic children over an 18-year period and compared them to more than 200 children without the disorder. The scientists found no differences in the overall frequency of gastrointestinal problems reported by the two groups, though the autistic children suffered more frequently from bouts of constipation and were more likely to be picky eaters who had difficulty gaining weight.

The study, published in the journal Pediatrics, is the first to look at the incidence of gastrointestinal problems in an autistic population, according to the paper’s author, Dr. Samar Ibrahim, a pediatric gastroenterologist at the Mayo Clinic. She suggested that autistic children should only be put on restrictive wheat-free or dairy-free diets ager having appropriate diagnostic tests done.

“There is actually no trial that has proven so far that a gluten-free and casein-free diet improves autism,” she said. “The diets are not easy to follow and can sometimes cause nutritional deficiencies.”

The study found that the vast majority of both autistic and non-autistic children suffered from bouts of common gastrointestinal problems like constipation, diarrhea, abdominal bloating, reflux or vomiting. Feeding issues and picky eating were also common. Some 77 percent of autistic children and 72 percent of non-autistic children were affected by one or more of these complaints over the 18-year period.

About 34 percent of the autistic children were affected by constipation, compared to 17.6 percent of the comparison group, while 24.5 percent of the autistic children had feeding issues and were selective in their eating, compared with only 16 percent of the non-autistic group. But very few of the autistic children had a specific diagnosis of a gastrointestinal disease. Only one autistic child had Crohn’s disease, and one had intestinal disaccharidase deficiency and lacked enzymes necessary to digest certain carbohydrates. None suffered from celiac disease, which some reports have linked to autism. Two of the non-autistic children in the comparison group suffered from lactose intolerance, and one had a milk allergy.

Dr. Ibrahim suggested that the loss of appetite and difficulty gaining weight in autistic children may be related to the use of stimulant medications, which are often prescribed for the condition, and that the constipation may be due to children not consuming enough fiber or drinking enough water.

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posted by Chavon Williams at 6:55 AM

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