FDA warns doctors on GSK’s Avandia

The New England Journal of Medicine has published a study reporting a 43% increase in the risk of heart attacks in people taking Avandia and potentially a 64% increase in the risk of cardiovascular deaths. The study prompted the agency to issue a warning of a possible risk to health professionals, although added that other studies provide contradictory evidence.

The FDA also said that it would convene an advisory committee as soon as possible in order to investigate any possible risks, and in the meantime has not asked GlaxoSmithKline to take any action.

The US Senate Committee on Finance, which has jurisdiction over the Medicare program, has also responded to the study by asking the drug maker to respond to allegations that company executives sought to silence independent scientist about risks with Avandia.

GSK said: “The suggestion that GlaxoSmithKline has placed patients at risk and attempted to silence independent investigation of data is absolutely false. Any fair examination of the company's record will show that GSK has been fully transparent in its efforts to thoroughly study the safety and effectiveness of Avandia, and to widely communicate that information to governments, scientists, physicians, and the public in the best interests of both patients and scientific debate.”

Since Avandia was approved, the FDA has been monitoring several heart-related adverse events. The most recent labeling change for Avandia included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.