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FDA panel advises easing restrictions on rosiglitazone

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3769 (Published 10 June 2013) Cite this as: BMJ 2013;346:f3769
  1. Miriam E Tucker
  1. 1Bethesda, Maryland

A joint Food and Drug Administration advisory panel has voted to ease the current stringent restriction on prescription of the antidiabetes drug rosiglitazone (marketed by GlaxoSmithKline as Avandia), despite lingering concerns about its cardiovascular safety.

The three year old restrictions, formally known as a “risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) program,” called for certification of the physician and the dispensing pharmacy and for medication guides for patients and physicians.1 They also limited the drug’s use to patients who were already taking it before the restrictions were placed and to patients for whom no other glucose lowering agents are acceptable.

The vote took place on the second day of a two day joint meeting of the FDA’s endocrinologic and metabolic drugs advisory committee and its drug safety and risk management advisory committee. The vote was split, with just half of the total of 26 members opting to keep …

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