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Rosiglitazone Should Be Removed from the Market, Some FDA Staff Advise
On Friday, February 19., 2010, a New York Times article reported that some FDA staff are recommending that rosiglitazone, sold in the U.S. as Avandia to treat type 2 diabetes, "be removed from the market."
The story, based on "internal FDA reports" and a Senate Committee on Finance staff report, says that "hundreds of people taking Avandia ... needlessly suffer heart attacks and heart failure each month." The committee report concludes: "The totality of evidence suggests that [GlaxoSmithKline] was aware of the possible cardiac risks associated with Avandia years before such evidence became public."
In separate press releases, GlaxoSmithKline disputes the conclusions, both of the Times article and the Senate report, saying that "the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events."
In May 2007, a Cleveland Clinic study published in the New England Journal of Medicine found that patients taking Avandia had a 43-percent higher risk of having a heart attack. In August of 2007, The FDA approved a Black Box Warning for Avandia about its link to heart attacks. At the same time, the FDA also approved a black box warning for Avandia about its association with congestive heart failure. The new warning said that patients with the most severe forms of heart failure should not take the drug, and that thiazolidinediones are not recommended for patients with heart failure that causes symptoms. The warnings also advise that doctors should reconsider the use of drugs like Avandia if a patient develops heart failure while taking thiazolidinediones.
If you or someone you love tookAvandia and suffered from serious side effects, including heart attack and fatal congestive heart failure, you have valuable legal rights. Please call our toll-free number (1-800-431-4600) to discuss your case with one of our Avandia injury lawyers.