May 18th, 2011
FDA Announces Details of Severe New Restrictions on Rosiglitazone
Larry Husten, PHD
The FDA has announced the details of the updated REMS (risk evaluation and mitigation strategy) for rosiglitazone, the embattled and highly controversial diabetes drug. The new REMS will sharply restrict access to and distribution of drugs containing rosiglitazone (Avandia, Avandamet, Avandaryl).
In order for physicians to prescribe and for patients to receive rosiglitazone, they will need to enroll in a special program mandated by the FDA, called the Avandia-Rosiglitazone Medicines Access Program. Rosiglitazone will now be restricted for use by patients already being successfully treated with the drug or by patients who have failed other anti-diabetic drugs and who do not wish to use pioglitazone.
After November 18, 2011, rosiglitazone will only be available by mail order through pharmacies participating in the program.
The FDA action follows an FDA advisory panel last summer and the subsequent FDA announcement in September that it would significantly restrict the use of rosiglitazone.
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