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."