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February 8, 2011

GlaxoSmithKline Revises Troubled Avandia Label

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

By cms admin

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.

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