European Medicines Agency holds back on GlaxoSmithKline Avandia decision

The European Medicines Agency (EMEA) announced yesterday that it is still reviewing GlaxoSmithKline's controversial diabetes drug Avandia (rosiglitazone), which has been linked to cardiovascular side effects - though recommended for continuation of marketing by a Food and Drug Administration advisory panel earlier this week (The Pharma Letter July 21). The EMEA said it will recommend whether or not the drug should stay on the market by September.

Avandia has been contra-indicated in patients with heart failure or a history of heart failure since its first authorization in July 2000, the Agency noted. It was subsequently approved in combination with metformin as Avandamet and with glimepiride as Avaglim. Since then, the use of these medicines has been further restricted several times by new warnings and contra-indications on their use in patients with heart problems, the EMEA pointed out.

The current review of rosiglitazone was initiated on July 9 on the request of the European Commission following publication of studies questioning the cardiovascular safety of the medicine. At its July 19-22 meeting the Agency's Committee for Medicinal Products for Human Use (CHMP) held preliminary discussions, including with experts in diabetes, cardiovascular diseases and pharmacovigilance and with patients.