National non-profit organization documents upsurge in negative clinical data associated with use of Avandia, urges FDA commissioner to remove drug from U.S. market immediately
Mineola, N.Y. (Lexis Nexis) November 6, 2008 -- Public Citizen, a non-profit organization representing more than 80,000 consumers nationwide, has petitioned the Commissioner of the U.S. Food and Drug Administration to immediately ban the diabetes drug Avandia, according to Marc Grossman, a member of the Avandia Plaintiffs Steering Committee.
According to the petition, recent clinical studies documented that Avandia has caused an increased risk of heart attacks, heart failure, bone fractures, anemia and retinal edema with vision loss. Perhaps most seriously, the group analyzed 14 cases of liver failure in patients who were taking Avandia, 12 of which resulted in death.
"In the past year, there were 4.6 million (Avandia) prescriptions filled, thus exposing hundreds of thousands of people with diabetes to a drug that is clearly doing more harm than good," according to the Public Citizen petition. "Thus, it is urgent for the FDA to immediately ban rosiglitazone (Avandia)."
The Avandia Plaintiffs Steering Committee has been tracking the reports of multiple serious side effects from Avandia for the past year and represents a number of plaintiffs in litigation against the manufacturer of the drug, GlaxoSmithKline. Many nationwide lawsuits have been centralized in Federal court in the Eastern District of Pennsylvania in front of Hon. Cynthia Rufe, (In Re: Avandia Marketing, Sales Practices and Products Liability Litigation, 2:07-md-01871-CMR). This litigation involves thousands of claims for injuries ranging from death and heart attack to vision loss and bone fractures.
"The Public Citizen petition, along with prior recommendations against the use of Avandia from both the American Diabetes Association and the European Association for the Study of Diabetes, is certainly a step in the right direction," said Vance Andrus, lead counsel for the Avandia Plaintiffs Steering Committee. "Many doctors and patients were led to believe that this was a safe and effective drug and, as a result, their lives were put in danger."
Any adverse reactions experienced with the use of Avandia should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Read the full story at http://www.prweb.com/releases/2008/11/prweb1572304.htm
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