Congressional Hearings Focus on FDA's Handling of Avandia
At a June 6, 2007, congressional hearing, the U.S. Food and Drug Administration was questioned on its handling of the dangers associated with GlaxoSmithKline's diabetes drug Avandia.
Rep. Henry Waxman (D-Calif.), chairman of the Committee on Oversight and Government Reform, accused the FDA of being to lax in monitoring the safety of Avandia. He said the FDA never completed a required post-market study of the drug, constituting "a major failure of our system."
"It's about time someone recognizes the flaws in our drug approval and monitoring processes," says W. Mark Lanier of The Lanier Law Firm in Houston. "It is far too easy for dangerous drugs to stay on the market simply because they are profitable."
The hearings were prompted by a recent New England Journal of Medicine article suggesting that Avandia significantly increases the risk of heart attacks and cardiovascular death. The article analyzed several clinical trials comparing patients taking Avandia with those not using the drug. The results indicated Avandia increased patients' chances of heart attack by 43 percent and cardiac-related death by 64 percent.
In response to the article, the FDA issued a Safety Alert advising patients to talk with their doctor about Avandia's risks. Nearly seven million people worldwide have taken Avandia.
The Lanier Law Firm is currently investigating claims against Avandia and its manufacturer, GlaxoSmithKline. The firm's Pharmaceutical Liability Practice Group has decades of experience representing clients who have been injured by dangerous drugs.
If you or a loved one has taken Avandia and suffered side effects, please contact our office for a free evaluation.
