GlaxoSmithKline Revises Troubled Avandia Label

8 February 2011 (Last Updated February 8th, 2011 18:30)

GlaxoSmithKline is to revise prescribing information and medication guides for its medicines containing rosiglitazone, including Avandia, to include additional safety information. The revision follows a US Food and Drug Administration review of cardiovascular event data in type 2 dia

GlaxoSmithKline is to revise prescribing information and medication guides for its medicines containing rosiglitazone, including Avandia, to include additional safety information.

The revision follows a US Food and Drug Administration review of cardiovascular event data in type 2 diabetes patients treated with Avandia and an FDA decision in September 2010 to restrict access to the drug.

GlaxoSmithKline has established a risk evaluation and mitigation strategy programme designed to restrict availability of these medicines.

The revised label restricts use to patients already taking a rosiglitazone-based medication or to patients unable to achieve adequate glycaemic control using other diabetes medications, as well as to those who have decided not to take pioglitazone-containing medicines for medical reasons.