scrutiny because of cardiovascular safety concerns (eg, myocardial infarction and stroke).
A memorandum issued by Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, states that the drug will be permitted to remain on the market in a restricted capacity. The FDA is requiring Avandia's manufacturer, GlaxoSmithKline (GSK), to undertake a restricted access program under the agency's Risk Evaluation and Mitigation Strategy (REMS) initiative to include elements to ensure the safe use of the product. 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), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.
In addition to the REMS requirement, GSK must commission an independent readjudication of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes (RECORD) study. GSK is also being instructed to place the postmarketing trial known as Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) on full clinical hold.
In a summary statement, Dr Woodcock remarked that multiple and conflicting signals of cardiovascular ischemic risk exist in relation to rosiglitazone use. Despite the lack of clarity in the data, she believes it is most prudent, given the current uncertainty about the safety risk, to restrict access to the product, and ensure that patients and prescribers are fully informed of the evidence of risk, until and unless more information is obtained
