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Diabetes Drug Avandia: Heart Risk?

Study Shows 43% More Heart Attacks With Avandia; Drugmaker Says Study Is Flawed

Avandia Safe, GlaxoSmithKline Says

GlaxoSmithKline has done its own analysis of Avandia's heart safety data. Using techniques similar to those used in the Nissen study, the GSK study showed about a 30% increase in heart risk to patients taking Avandia.

But a study of 33,000 patients in a managed-care database showed no increased heart risk in patients taking Avandia. Both this study and the GSK analysis were given to the FDA in August 2006.

Ongoing, long-term studies also support Avandia safety, says GSK chief medical officer Ronald Krall, MD.

"I want to be very clear that we are confident in the benefit/risk profile for Avandia. We believe that if it is used according to the directions incorporated into U.S. and European labels, it is an important treatment for patients with type 2 diabetes," Krall says in a news release. "We believe that important evidence coming from long-term studies supports the safety of Avandia."

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