FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
[5-18-2011] The U.S. Food and Drug Administration (FDA) is informing the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs.
The new restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS)—a program FDA may require to manage serious risks of marketed drugs. The restrictions are based on data that suggested an elevated risk of heart attacks in patients treated with rosiglitazone. The decision to restrict access to rosiglitazone medicines was made on September 23, 2010.
Facts about rosiglitazone
- Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).
- The nationally projected number of patients filling a rosiglitazone-containing product declined by 50% from 235,500 patients in January 2010 to around 119,000 patients in October 2010.1
FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products.
The REMS, called the Avandia-Rosiglitazone Medicines Access Program, limits the use of rosiglitazone medicines to:
- Patients already being successfully treated with these medicines.
- Patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare provider, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
Healthcare providers and patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to prescribe and receive rosiglitazone medicines. After November 18, 2011, rosiglitazone medicines will no longer be available through retail pharmacies. Patients who are enrolled in the Avandia-Rosiglitazone Medicines Access Program will receive their medicine by mail order through specially certified pharmacies participating in the program.
- 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.
- 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.
On September 23, 2010, FDA announced that it would significantly restrict the use of rosiglitazone medicines to patients with type 2 diabetes who cannot control their blood sugar on other medicines. These new restrictions were instituted in response to data that suggest an elevated risk of heart attacks in patients treated with rosiglitazone.
The REMS for Avandia, Avandamet, and Avandaryl includes elements to assure safe use (ETASU), which consist of a new restricted access and distribution program for the drug products that contain rosiglitazone.
For complete safety reviews and background information on rosiglitazone, please see:
FDA significantly restricts access to the diabetes drug Avandia.
- SDI, Vector One®: Total Patient Tracker (TPT). January 2010-October 2010. Data extracted 12-15-10.
- FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines
- FDA significantly restricts access to the diabetes drug Avandia
- FDA Drug Safety Podcast for Healthcare Professionals: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
- Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information