FDA DECISION: AVANDIA RESTRICTED IN THE UNITED STATES
Europe Halts Avandia Sales
The U.S. Food and Drug Administration announced today that sales of all rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl) will be restricted to patients with Type 2 diabetes whose condition cannot be controlled with other medications. The FDA will also require a Risk Evaluation and Mitigation Strategy program with additional measures to ensure the safe use of the medicine by those patients who are permitted to take the medications. The restricted use of the drugs is the result of data showing an increased risk of cardiovascular side effects of the drugs, including heart attack (myocardial infarction), as well as an increased risk of bone fractures in patients taking the drugs.
The European Union's equivalent of the FDA, called the EMA, decided that the risks to patients taking the diabetes drugs were too great and announced its decision to suspend the marketing of all rosiglitazone-containing medications. The EMA stated that the suspension will remain in place unless convincing data are provided showing that the benefits of the medicine outweigh its risks.
The Avandia family of drugs was a major source of profits for GSK. Despite strong evidence that the risks of serious side-effects associated with the drugs outweighed the benefits, GSK continued to market the medications as safe and effective. It took FDA a number of years to review the data, which resulted in thousands of consumers being exposed to a dangerous drug unnecessarily given the fact that other diabetes drugs work as well but do not have the risks of serious side-effects. The U.S. Food and Drug Administration has been criticized for its handling of the approval process and post-marketing safety review of drugs, including Vioxx and Avandia. FDA's decision to restrict the use of the drugs is certainly a step in the right direction to gain back consumers' trust in the overall manner which pharmaceuticals are approved for sale in the United States.
If you or a loved one were injured as a result of ingesting Avandia, Avandamet or Avandaryl, please contact us online or by telephone at 850-444-9500. Your legal rights are important to us.
SENATE COMMITTEE MEMBERS DEMAND ANSWERS ON RISKS OF AVANDIA®
February 19, 2010. Confidential studies by Food and Drug Administration officials recommend that GlaxoSmithKline's diabetes drug Avandia® be pulled from the market because it is linked to heart attacks. The studies, released as part of a report on Avandia® by staff of Senate Finance Committee members Chuck Grassley (R., Iowa) and Max Baucus (D., Mont.), also say any head-to-head trial where patients get Avandia® and Takeda's diabetes medicine Actos® would be "unethical and exploitative." GlaxoSmithKline is currently sponsoring a study, called TIDE, where patients get either Avandia®, Actos® or other medicines.
"Rosiglitazone should be removed from the market," one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn. In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.'s drug center, wrote that "there are multiple conflicting opinions" about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.
"I await the recommendations of the advisory committee," the agency's commissioner, Dr. Margaret Hamburg, said Friday night. "Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved."
In 2007, Cleveland Clinic cardiologist Dr. Steve Nissen published a study in the New England Journal of Medicine that found a 43% higher risk of cardiovascular events for patients taking Avandia®. Glaxo publicly denounced the findings, but internal emails since released and included as part of the Senate Finance Committee report indicate that company scientists felt the company's own numbers were similar to Dr. Nissen's.
The company has faced criticism that it has known about the heart-attack risks associated with Avandia® for years. Glaxo added a "black box" warning to Avandia® in November 2007 that says the drug can cause or exacerbate congestive heart failure.
The company has also faced accusations that it attempted to intimidate scientists and doctors outside the company who raised questions about the safety of Avandia®. The Senate Finance Committee report concludes that Glaxo was aware of the possible cardiac risk years prior to Dr. Nissen's study. The report says Glaxo had a duty to warn patients and the FDA about its concerns in a timely manner. "Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia® may increase cardiovascular risk, and sought ways to downplay findings that the rival drug Actos® might reduce cardiovascular risk," the report says.
Since being introduced for the treatment of diabetes, the Avandia® family of drugs (Avandia®, Avandamet® and Avandaryl®) has been linked to a variety of serious side effects, including fatal cardiovascular problems, macular edema and bone fractures.
If you or someone you love were injured as a result of ingestion of Avandia, you may be entitled to financial compensation. Please contact one of our Avandia® injuries lawyers online or call us at 1-850-444-9500 as soon as possible to protect your legal rights.