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Avandia Faces Justice Department Probe

Oct 22, 2010 | Parker Waichman LLP

Avandia, GlaxoSmithKline’s controversial diabetes drug, is coming under more scrutiny. According to a Wall Street Journal report, the drug maker has disclosed that it has been subpoenaed by the US Department of Justice over Avandia.

According to Glaxo’s third-quarter earnings announcement, the Justice Department is seeking information regarding development and marketing of Avandia. It’s not clear if the Justice Department probe is criminal or civil in nature, the Journal said.

In addition to the Justice Department, attorneys general in several states are also asking questions about Avandia. Glaxo also acknowledged that consumer lawsuits regarding Avandia “continue to be filed.”

Last month, the US Food & Drug Administration (FDA) restricted sales of Avandia, as well as two related drugs called Avandamet and Avandaryl, after concluding their association with an increased risk of heart attacks and strokes outweighed the drugs’ benefits for most patients. At the same time, regulators in Europe announced that sales of Avandia and related drugs would be suspended.

Since November 2007, Avandia’s US label has included a black box warning – the FDA’s strongest safety alert – detailing its association with myocardial ischemia. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack. Since the addition of the black box, evidence linking Avandia to an increased risk of heart attacks has continued to accumulate.

Earlier this year, a Senate Finance Committee report accused Glaxo of knowing about data linking Avandia to an elevated risk of cardiovascular events for several years, but playing down and trying to suppress the concerns.

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