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Avandia Rejected by German Drug Regulator

Jun 21, 2010 | Parker Waichman LLP

A German regulator has rejected Avandia, directing health insurers in that country to stop paying for GlaxoSmithKline’s controversial diabetes drug. The decision comes just a month before a U.S. Food & Drug Administration (FDA) advisory panel meeting is held on Avandia.

According to Reuters, Germany’s Federal Joint Committee of doctors and health insurers cited bone fracture and heart risks associated with Avandia’s class of drugs. The ban on glitazone medicines also include Actos, sold by Japan’s largest drugmaker Takeda.

“There are other pharmaceuticals that have no such side effects and long-term risks,” The committee’s chairman Rainer Hess said. “We believe that patients should be protected against useless and, more importantly, harmful therapies.”

Avandia has been the subject of safety concerns for several years. In November 2007, a black box warning – the FDA’s strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. 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.

Earlier this year, the Senate Finance Committee released a report detailing its 2-year Avandia investigation. According to the report, in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks.

Earlier this month, we reported that an unpublished Avandia study had found that patients in the U .S. Medicare system who took the drug may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009. According to the study’s author, Dr. David Graham, a safety official with the FDA, the problems could have been averted had the patients taken a different drug.

Dr. Graham is a long-time critic of Avandia. The findings of his study will be included in data presented at next month’s FDA advisory panel meeting. Dr. Graham and others have argued that Avandia should be withdrawn from the market.

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