FDA Reports Recommend Pulling Diabetes Drug Avandia Because It May Be Causing Heart Attacks
By: Wendy Moyer | Posted: 26th March 2010
GlaxoSmithKline's Type 2 diabetes drug Avandia is in the spotlight again, drawing attention from personal injury law watchers.
A recent New York Times article cited confidential government reports that say the medication can cause personal injury, harming the heart and increasing the possibility of heart attacks and heart failure. They contend that "if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month...."
Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration (FDA) reports say the drug should be removed from the market, writes the Times.
A recent Senate report says GlaxoSmithKline (GSK) was aware of possible cardiac risks associated with Avandia for years before such evidence became public. The report asked the FDA to describe the steps it has taken to protect patients in an ongoing Avandia clinical trial since the agency has estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007, according a Senate press release.
The New York Times goes on to say that, "a Senate investigation concluded that GlaxoSmithKline should have warned patients earlier of the drug's potential risks."
Perhaps it wasn't pulled from the market because Avandia at one time was one of the biggest selling drugs in the world. In 2006 alone the drug accounted for $3.2 billion dollars in sales. In 2007, after a study by a Cleveland Clinic cardiologist suggested the potential harm the drug could cause the F.D.A. oversight board none-the-less voted 8 to 7 to permit Avandia to remain on the market.
Currently hundreds of thousands of patients are still taking the drug. GSK issued statements rejecting the conclusions of both the Senate and New York Times reports, saying Avandia is safe.
Not only do they reject the conclusions, but according to the Senate report, "Instead G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk."
Senator Max Bauccus (D-Montana) said, "Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust."
Despite a 2007 study correlating Avandia and the risk of heart failure, the FDA has allowed the drug to remain on the market. Personal injury law in many states offers several claim routes for personal injury compensation for individuals who have been seriously injured by prescription drugs like Avandia.
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Tags: heart attacks, personal injury law, food and drug administration fda, food and drug administration, heart failure, type 2 diabetes