Rosiglitazone to Be Available Only by Mail Order, FDA Says

The Food and Drug Administration has further restricted use of the diabetes drug rosiglitazone and all other medications containing rosiglitazone by requiring that health care providers and patients enroll in a special program, and by removing the drugs from all retail pharmacies by Nov. 18, 2011.

The new restrictions are part of the FDA’s REMS (Risk Evaluation and Mitigation Strategy), a program for managing serious risks of marketed drugs. The initial decision to restrict access to rosiglitazone was made on Sept. 23, 2010, based on data suggesting an elevated risk of heart attacks in patients who were treated with the glucose-lowering agent. Previously, the REMS consisted of a medication guide. Now, the FDA has modified the REMS to include a restricted access and distribution program, which applies to Avandia, Avandamet, and Avandaryl.

The officially titled Avandia-Rosiglitazone Medicines Access Program limits the use of all three drugs to patients who are already being successfully treated with them, or to those whose blood sugar cannot be controlled with any other medications and who do not wish to use pioglitazone-containing drugs (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

Furthermore, health care providers and patients must now be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to prescribe and receive rosiglitazone medicines. Patients who are enrolled in that program will receive their medicine by mail order through specially certified participating pharmacies.

Heath care providers should determine whether their patients are appropriate candidates to receive treatment with rosiglitazone medicines, based on the risks and benefits compared with other therapies. Enrollment in the Avandia-Rosiglitazone Medicines Access Program is required for health care providers who wish to prescribe rosiglitazone medicines to outpatients or to patients in long-term care facilities.

To enroll, health care providers must review the prescriber overview and the full prescribing information, including the medication guide, and must complete and sign the prescriber enrollment form. A copy of the medication guide must be provided to and reviewed by the patient or caregiver, and the health care provider must enroll eligible patients into the program by completing and signing a patient enrollment form. If a patient who has been taking a rosiglitazone medicine is hospitalized, the patient must be enrolled in the Avandia-Rosiglitazone Medicines Access Program to continue receiving the medicine; however, the patient’s health care provider in the hospital is not required to be enrolled.

Any adverse events involving rosiglitazone medicines should be reported to the FDA MedWatch program.