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GSK revises US Avandia label to include FDA usage restrictions

PBR Staff Writer Published 09 February 2011

GlaxoSmithKline (GSK) has revised the labels of all its rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl) to conform to the US Food and Drug Administration’s guidelines.

The new labels now carry US prescribed information on medication guides, additional safety and restrictions on the use of these medicines for cardiovascular event data in type 2 diabetes patients treated with Avandia, GSK said.

The revised labels restrict use to patients already taking a rosiglitazone-containing medicine or to new patients who are unable to achieve adequate glycemic control on other diabetes medications.

They also restrict the use of these medicines by those, who in consultation with their healthcare provider, have decided not to take Actos (pioglitazone) or other pioglitazone-containing medicines for medical reasons.

Other revisions to the label content include changes to the Boxed Warning, Indications and Usage, Dosage and Administration, and Warnings and Precautions.