Avandia® and Risk of Heart Attacks

Filed in archive Cardiovascular Health , Controversies , Diabetes , Treatment on November 14, 2007

Remember the verdict on Avandia® despite the controversy that has linked this diabetes drug by GlaxoSmithKline (GSK) to increased risk of heart attacks?

Yes, Avandia® was allowed to stay in the market, as approved by the FDA panel of advisers.

Avandia®, manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa., was approved in 1999 as an adjunct to diet and exercise to improve control of blood sugar levels.

Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.

But now, the FDA recently announced that the manufacturer of Avandia® - GSK - has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.

According to Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research:

"FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings.

FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines."

Find more details from the FDA News.