FDA to Greatly Restrict Use of Rosiglitazone

Action is response to data suggesting higher risk of cardio events with use of the diabetes drug
By Andrea Mongler
HealthDay Reporter

THURSDAY, Sept. 23 (HealthDay News) -- The U.S. Food and Drug Administration has announced plans to substantially restrict the use of rosiglitazone (Avandia) in type 2 diabetes patients unable to control their disease with other medications.

The agency is taking the action in response to data suggesting an increased risk of cardiovascular events, including stroke and myocardial infarction, in patients treated with rosiglitazone. The FDA is requiring the drug's manufacturer, GlaxoSmithKline, develop a restricted access program for the drug, which will be available to new patients only if they cannot achieve glucose control with other medications and cannot take pioglitazone. Current rosiglitazone users can keep taking the drug if they are benefiting.

Under the new program, physicians will need to attest to and document patient eligibility, while patients will have to review and acknowledge cardiovascular safety concerns associated with rosiglitazone. The FDA has also ordered GlaxoSmithKline to convene an independent group of scientists to review the RECORD trial, which compared the safety of rosiglitazone and standard diabetes drugs. During this trial, questions arose about potential bias in the identification of cardiovascular events. In addition, the FDA has stopped GlaxoSmithKline's TIDE trial, which compared rosiglitazone to pioglitazone and standard diabetes drugs.

"Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement.

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