FDA Considers Whether to Pull the Plug on Avandia Study
According to the Wall Street Journal, the U.S. Food and Drug Administration is considering halting a study involving the diabetes drug Avandia due to concerns about heart attack risks.
If the agency stops the so-called TIDE study -- which compares the safety of Avandia and its competitor Actos -- it could also lead to the removal of Avandia from the U.S. market.
The FDA has been a defender of the diabetes drug, made by GlaxoSmithKline, despite the publication of studies that link Avandia’s use to 83,000 heart attacks between 1999 and 2007.
In late February, a Senate Finance Committee released a report that was highly critical of GlaxoSmithKline. After a two-year investigation, the committee concluded that the drug maker knew of the heart attack risks associated with Avandia but hid them from the public. The report also questioned the FDA’s close ties with Glaxo.
In March, FDA Commissioner Margaret Hamburg sent a letter to Sen. Chuck Grassley, indicating that the agency was reassessing the TIDE trial.
The FDA now says it has asked the Institute of Medicine to review the ethics of continuing the study comparing Actos and Avandia.
If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey, Danis & Lowe. We can help. Carey, Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.
