Diabetes Drug Tied To Heart Risks

The widely prescribed diabetes drug Avandia is linked to a greater risk of heart attack and possibly death, says a new scientific analysis published online this week.

More than six million people worldwide have taken the drug sold by London-based GlaxoSmithKline PLC (GSK) since it came on the market eight years ago. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack, according to the review published by the New England Journal of Medicine.

Experts said the overall risk was small and cautioned people not to stop taking the drug on their own, but to talk to their doctors.

The company downplayed the report of heart risks, saying the analysis by Dr Steven Nissen and statistician Kathy Wolski at the Cleveland Clinic is not definitive scientific proof. In a conference call Monday, Dr Lawson McCartney, who leads Glaxo’s diabetes drug development, said the company is not seeing “anything like” the problems reported in the medical journal.

“We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine,” Dr McCartney said.

The government will take no immediate action on a label change or other measures regarding the drug, said Dr Robert J. Meyer of the US Food and Drug Administration’s Center for Drug Evaluation and Research.

FDA officials acknowledged that Glaxo submitted information last August indicating some increased risk from the drug but that other studies were contradictory. However, several members of Congress expressed alarm at the report and said they would hold hearings on the safety issues.

Worried patients should not quit Avandia on their own and should discuss concerns with their doctors, wrote Drs Bruce Psaty and Curt Furberg in an editorial in the New England Journal of Medicine. Dr Psaty is with the University of Washington in Seattle and Dr Furberg is with Wake Forest University.

The information in this article was excerpted from a longer story from The Associated Press.