Three years ago, amid concerns that rosiglitazone (Avandia) increases the risk of myocardial infarction and death due to cardiovascular causes, the US Food and Drug Administration (FDA) severely curtailed use of the blood glucose–lowering drug. But now an FDA advisory committee has recommended easing the severe restrictions on prescribing rosiglitazone, used to treat type 2 diabetes mellitus, even though cardiovascular safety concerns remain.
At the joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, held June 5 and 6 at FDA headquarters in Silver Spring, Maryland, 13 members voted to modify the highly restrictive risk evaluation and mitigation strategy (REMS) applying to use of rosiglitazone, 7 voted to remove the REMS altogether, 5 voted to keep the REMS as is, and 1 voted for removal of rosiglitazone from the market. The REMS restricts access to rosiglitazone so that only prescribers who acknowledge the potential increased risk of myocardial infarction are prescribing the drug. The REMS also restricts rosiglitazone to patients who are already taking the drug or who are unable to achieve glycemic control with other medications and, in consultation with their physician, have decided not to take pioglitazone (Actos, the only other thiazolidinedione marketed in the United States) for medical reasons.
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An advisory panel, after hearing testimony by researchers, is recommending the US Food and Drug Administration ease severe restrictions on rosiglitazone.
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