Access to Rosiglitazone to Be Restricted, Says FDA

Physicians who wish to continue prescribing rosiglitazone-containing medications soon will be required to enroll themselves and their affected patients in a risk evaluation and mitigation strategy, or REMS, program.

FDA officials said during a May 24 conference call that enrollment in the REMS program (28-page PDF; About PDFs) is expected to start by mid-July. According to a May 18 safety announcement from the agency, physicians and patients will have until Nov. 18 to complete the one-time enrollment. After that date, rosiglitazone will no longer be available through retail pharmacies. Instead, patients who enroll will receive their medications by mail from certified pharmacies.

During a July 2010 joint meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and the agency's Drug Safety and Risk Management Advisory Committee, a plurality of the committees' members voted to recommend that the agency remove rosiglitazone from the market because of cardiovascular risks associated with the product.

The FDA, however, did not remove the product, although the agency did announce in September 2010 that it planned to restrict the use of rosiglitazone medications. As part of that announcement, the FDA said it would require manufacturer GlaxoSmithKline to develop a restricted access program for the affected medications:

The agency specified in its May 18 announcement that access to the drug will be limited to the following groups of patients:

FDA officials also outlined the following details of the REMS:

Use of rosiglitazone already has been cut in half. According to the FDA, the number of U.S. patients filling prescriptions for rosiglitazone-containing products declined from 235,500 in January 2010 to about 119,000 patients in October 2010.