EMEA seeks expanded rosiglitazone warning

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) says that the warning information for GlaxoSmithKline's antidiabetic drug rosiglitazone should be updated. Specifically, the Committee has advised that labeling for Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin) and Avaglim (rosiglitazone maleate/glimepride) include guidance recommending against their use by diabetics with ischemic heart disease and/or peripheral arterial disease.

The committee also advised that product's containing rosiglitazone be contraindicated for patients with acute coronary syndrome, including both angina and some types of myocardial infarction, as the agent has not been studied in controlled trials of such patients group. In the USA, Avandia's labeling already includes this guidance (Marketletter November 19, 2007).

Risk/benefit profile still positive