Long-Awaited Rosiglitazone Risk-Management Strategy Released

Disclosures

May 18, 2011

May 18, 2011 (Washington, DC) — The FDA has come through with a risk evaluation and mitigation strategy (REMS) for the use of rosiglitazone (Avandia, GlaxoSmithKline) [1], the controversial diabetes drug that some of the agency's expert advisors wanted to banish and others preferred to keep but with tight restrictions on its use. The agency had promised a REMS program last September, as reported by heartwire .

There is abundant evidence that rosiglitazone can up the risk of heart failure, MI, or death in some patients who take it for glucose control, compared with its cousin pioglitazone (Actos, Takeda). But some patients can take it successfully, and for others it may be the last best bet among antidiabetic agents, some argue.

The new document limits the drug to patients already successfully treated with it or those for whom it's pretty much a last-ditch effort to control blood glucose medically [2]. Moreover, "healthcare providers and patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to prescribe and receive rosiglitazone medicines," the FDA statement says.

It will require, among other things, that providers who want to prescribe rosiglitazone, as well as pharmacies that distribute the drug, be specially trained and certified for the purpose. Also, patients will no longer be able to get it in person at their neighborhood pharmacy--it will be available to them only by mail.

In a "Dear healthcare provider" letter published as part of the REMS document, GlaxoSmithKline states, "You must be enrolled in the rosiglitazone REMS program in order to prescribe rosiglitazone. As part of this program, you will be educated about the potential increased risk of myocardial infarction and the need to limit the use of rosiglitazone to eligible patients."

The FDA has been roundly criticized for slowness in publishing a REMS for rosiglitazone, which had previously been stipulated by the agency for the drug's continued availability in the US, based on the majority vote at last year's joint meeting of its Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee.

The European Medicines Agency went further than its US counterpart last year by putting a complete halt on the sale of medications in the European Union that contain rosiglitazone.

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