Access to Rosiglitazone to Be Restricted, Says FDA

Physicians, Patients Required to Enroll in REMS Program

June 01, 2011 04:50 pm News Staff

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( 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.

Cardiovascular Risks Prompt Restrictions

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:

  • rosiglitazone, which is marketed as Avandia;
  • rosiglitazone and metformin, which is marketed as Avandamet; and
  • rosiglitazone and glimepiride, which is marketed as Avandaryl.

REMS Lists Prescribing Limitations

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

  • those already being successfully treated with these medications; and
  • those whose blood sugar cannot be controlled with other diabetes medications and who, after consulting with their health care professional, do not wish to use pioglitazone-containing medicines.

FDA officials also outlined the following details of the REMS:

  • Physicians should determine whether their patients are appropriate candidates to receive treatment with rosiglitazone-containing medications based on the risks and benefits of the medications versus those of other therapies.
  • Physicians are required to review the prescriber overview and prescribing information, including the medication guide, and complete and sign the prescriber enrollment form included in the REMS document.
  • Physicians must provide a copy of the medication guide for the prescribed medicine and review it with the patient or caregiver.
  • Physicians must complete and sign a patient enrollment form so that the patient may begin or continue to receive rosiglitazone medications.
  • If a patient who has been taking a rosiglitazone medication is hospitalized, the patient must be enrolled to continue receiving the drug; however, the patient's health care professional in the hospital is not required to be enrolled.
  • Report any adverse events involving rosiglitazone medications to the FDA's MedWatch program(

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.