On July 30th, the FDA's Endocrinologic and Metabolic Drugs advisory committee and the Drug Safety and Risk Management advisory panel will discuss cardiovascular risks associated Avandia's class of drugs, thiazolidinediones.
The FDA also plans to seek the opinion of experts on whether Avandia should be limited to certain patients, or if Glaxo should include a "black box" warning to the drug.
The FDA was prompted to open a prob after an article in a medical journal in May that suggested patients taking the drug have a 43 percent higher risk of suffering a heart attack. The FDA will also ask experts if an increased risk of heart attack, possibly associated with Avandia, is greater than the risk associated with rival diabetes treatments, including Takeda Pharmaceutical's Actos, Merck and Co.'s Januvia.
More than 6 million people worldwide have taken Avandia or a related drug, Avandamet, since it hit the market in 1999. The pills help control blood sugar levels in patients with adult-onset diabetes.
