Diabetes Drug Avandia: Heart Risk?
Study Shows 43% More Heart Attacks With Avandia; Drugmaker Says Study Is Flawed
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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."