Access To Justice

FDA Panel Votes Not to Ban Avandia Despite Heart Attack Risk

by Sokolove Staff on Jul.14, 2010

GlaxoSmithKline’s embattled Avandia won a reprieve today after a Food and Drug Administration (FDA) advisory panel voted to keep the diabetes pill on the market despite evidence that it increases the risk of heart attacks.

The 33-member panel voted 20-12 against banning the sale of Avandia although those who wanted to keep the drug on the market also favored adding new warning labels and restricting its use, reports the Associated Press.

A majority of the panel also ruled that Avandia did not appear more likely to cause death than other diabetes drugs, according to the AP. The vote surprised observers since earlier the panel found sufficient evidence that Avandia may increase the risk of heart attack and stroke compared to other diabetes medications.

The FDA will now review the panel’s recommendations and make the final call on Avandia’s fate.

Avandia (rosiglitazone) is used to control blood sugar in people with type 2 diabetes, the most common form of the disease. Its safety  has come under increasing attack since February, when the FDA and the US Senate released reports critical of the cardiac risks associated with it.  But the drug has been embattled since 2007, when a study by the Cleveland Clinic linked it to an increased risk of heart attack. The FDA issued a safety alert for Avandia that same year.

GSK has defended Avandia even as it has recently settled hundreds of lawsuits brought by patients alleging the drug caused heart attacks and other health issues.

If you believe that you or a loved one has been harmed by Avandia, Sokolove Law may be able to help.

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