FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl

Additional Information for Patients

• Contact your healthcare provider as soon as possible to determine if it is appropriate for you to continue taking a rosiglitazone medicine and, if it is, how to become enrolled in the Avandia-Rosiglitazone Medicines Access Program. Enrollment information is also available on the Avandia website (www.avandia.com). Your healthcare provider will need to complete and sign a patient enrollment form for you.
• After November 18, 2011, you will no longer be able to obtain your rosiglitazone medicine from a retail pharmacy. Enrollment in the Avandia-Rosiglitazone Medicines Access Program will be required for patients who wish to receive this medicine, which will only be available by mail from one of the certified pharmacies participating in the program.
• Read the Medication Guide you get along with your rosiglitazone medicine. It explains the risks associated with the use of rosiglitazone.
• Talk to your healthcare provider about the risks and benefits associated with rosiglitazone medicines, or if you have any specific concerns.
• Report any side effects from the use of rosiglitazone medicines to the FDA MedWatch program, using the information at the bottom of the page in the “Contact Us” box.

Additional Information for Healthcare Professionals

• Healthcare providers should determine whether their patients are appropriate candidates to receive treatment with rosiglitazone medicines based on the risks and benefits of taking rosiglitazone medicines versus other therapies.
• Enrollment in the Avandia-Rosiglitazone Medicines Access Program (access the REMS) is required for healthcare providers who wish to prescribe rosiglitazone medicines to outpatients or patients in long-term care facilities. To enroll, healthcare providers are required to:         
  • Review the prescriber overview and the full prescribing information, including the Medication Guide, for rosiglitazone medicines.
  • Complete and sign the prescriber enrollment form.

• Healthcare providers must provide a copy of the Medication Guide for the prescribed rosiglitazone medicine and review it with the patient or caregiver.
• Healthcare providers must enroll eligible patients into the Avandia-Rosiglitazone Medicines Access Program by completing and signing a patient enrollment form so that the patient may begin or continue to receive rosiglitazone medicines.
• 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 healthcare provider in the hospital is not required to be enrolled.

• Rosiglitazone medicines will no longer be available through retail pharmacies after November 18, 2011. The drug manufacturer, GlaxoSmithKline, will withdraw rosiglitazone medicines from the current supply chain and will provide pharmacies with instructions on returning the medicines.
• Under the Avandia-Rosiglitazone Medicines Access Program, rosiglitazone medicines will only be available to enrolled patients by mail order from certified pharmacies participating in the program.
• Report any adverse events involving rosiglitazone medicines to the FDA MedWatch program, using the information at the bottom of the page in the “Contact Us” box.

FDA significantly restricts access to the diabetes drug Avandia.