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 and to those, who in consultation with their healthcare provider, have decided not to take Actos (pioglitazone) or other pioglitazone-containing medicines for medical reasons. Patients should consult their healthcare professional for advice on the benefits and risks of Avandia. Other revisions to the label content include changes to the Boxed Warning, Indications and Usage, Dosage and Administration, and Warnings and Precautions. A copy of the updated prescribing information for each rosiglitazone-containing medicine has been made available by the FDA (New US Avandia Label; New US Avandamet label; New US Avandaryl label).
As part of the September decision, the FDA had required GSK to establish a Risk Evaluation and Mitigation Strategy (REMS) programme which will restrict availability of these medicines. GSK is working closely with the FDA to finalise the REMS programme.
The FDA had also required an independent re-adjudication of the endpoints reported in the cardiovascular safety study, RECORD. GSK continues to work to meet the FDA's request.
GSK is fully committed to patient safety and continues to work with the FDA in the best interest of patients. Patients should be advised to avoid abruptly discontinuing their diabetes medicine without consulting their physician.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.