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Liver Failure Deaths Linked to Avandia

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Public Citizen said yesterday that federal regulators have received 14 reports of Avandia-induced liver failure, including 12 deaths.  The consumer group is now calling on the Food & Drug Adminsitration (FDA) to ban the diabetes drug once and for all.

“The scientific evidence against Avandia is overwhelming,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in  news release. “The timing of these findings should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug.”

Public Citizen is just the latest group to criticize Avandia.  Earlier this month, the American Diabetes Association/European Association for the Study of Diabetes working group dropped Avandia from its treatment guidelines.

Public Citizen said yesterday it had identified 14 cases of Avandia-induced liver failure in the FDA’s Adverse Event Reporting System.  Of the 14 cases of  liver failure, 12 resulted in deaths.  The liver failure associated with Avandia, taken together with the drug’s risk of other side effects, including heart failure, fractures and vision loss, was too great to allow the drug to continue to be sold in U.S., the group’s petition to the FDA said.

Avandia has been a subject of controversy since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In June 2007, Congress held hearings to discuss the FDA’s handling of its safety issues. At those hearings, it was revealed that in 2005 GlaxoSmithKline had informed the FDA of a study it had conducted that produced similar results. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues.  Thus, the public was not made aware of the Avandia heart attack risk until the publication of the Cleveland Clinic article.

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