The FDA announced that it will significantly restrict the use of Avandia (rosiglitazone, from GlaxoSmithKline) to patients with type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events (eg, heart attack and stroke) in patients treated with Avandia.
The FDA will require that GlaxoSmithKline develop a restricted access program for Avandia under a Risk Evaluation and Mitigation Strategy (REMS). Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone, from Takeda). Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.
The FDA has also ordered GlaxoSmithKline to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs. The FDA may take additional actions after the independent re-analysis of RECORD is completed.
For more information visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm226956.htm.