On May 23, the US Food and Drug Administration (FDA) requested “black box” warnings for increased risk of congestive heart failure for patients with type 2 diabetes using rosiglitazone or pioglitazone to lower blood glucose levels.
The request for the warnings was announced by FDA Commissioner Andrew C. von Eschenbach, MD, during testimony at a June 6 hearing by the House Committee on Oversight and Government Reform. At the hearing, the commissioner faced questioning by House members on the FDA's role in evaluating the safety of rosiglitazone (Avandia by GlaxoSmithKline plc, London, England). The hearing was called days after researchers using meta-analysis suggested an increased risk for adverse cardiovascular events—including a significant risk for myocardial infarction—in patients treated with rosiglitazone for glycemic control (Nissen SE and Wolski K. N Engl J Med. 2007;356:2457-2471). The black box warning does not mention risk for myocardial infarction because the science is still debatable, the FDA said.
Mitka M. Diabetes Drug Warning. JAMA. 2007;298(2):166. doi:10.1001/jama.298.2.166-a