FDA’s Slow Review of Avandia-Heart Attack Data
Despite the findings of a new Senate report that underscores the link between the diabetes drug Avandia and heart attacks, the U.S. Food and Drug Administration has not moved to pull the drug off the market.
Instead, the Wall Street Journal reports, the FDA has informed doctors that it is reviewing the information and will discuss the issue at July FDA advisory committee hearing. Until then, it recommends that patients continue taking the drug made by GlaxoSmithKline.
The decision to keep Avandia on the market drew criticism from Rep. Rosa DeLauro (D-Conn). In a statement, the lawmaker who also chairs the House committee that control’s the FDA’s budget, asserted:
“I strongly urge the FDA to remove Avandia from the market until a truly independent, science-based advisory panel can evaluate the effectiveness of the drug. It is reprehensible that many people might have suffered heart attacks or heart failures as a result of taking this drug, especially if safer alternatives exist.”
The Avandia safety issue also highlights the FDA’s conflicting roles as the agency that approves drugs and is responsible for monitoring the safety. In fact, the group that is charged with post-market surveillance of drug safety reports to the division that approves new medications.
If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey & Danis. We can help. Carey & Danis is a national law firm that represents individuals injured by America’s largest corporations.