Avandia, the popular type 2 diabetes drug, will have a revised black-box label warning of its associated heart attack risks, announced GlaxoSmithKline, the drug's maker. Despite mandating this labeling change, FDA officials aren't seeking to have rosiglitazone (Avandia) pulled from the market because evidence of the drug's heart attack risk is inconclusive. According to an FDA official, there simply isn't enough evidence to indicate that heart attack risks are any higher with Avandia than other type 2 diabetes drugs.
The FDA advises health care providers to monitor patients with type 2 diabetes who are at cardiac risk and are taking Avandia. For more information about the labeling changes, visit http://www.fda.gov.