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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

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Welcome, my name is Catherine Chew, a pharmacist in the Division of Drug Information.  On May 18, 2011, the Food and Drug Administration issued a Drug Safety Communication 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, or 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.  

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 for Avandia, Avandamet, and Avandaryl includes elements to assure safe use, which consist of a new restricted access and distribution program for the drug products that contain rosiglitazone.

The REMS, called the Avandia-Rosiglitazone Medicines Access Program limits the use of rosiglitazone medicines to:

  • Patients already being successfully treated with these medicines, and
  • Patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consultion with their healthcare provider, do not wish to use pioglitazone-containing medicines including 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.

At this time, FDA recommends that Healthcare Professionals be aware that:

  1. 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.
  2. Enrollment in the Avandia-Rosiglitazone Medicines Access Program 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, and
      • Complete and sign the prescriber enrollment form.
  3. Healthcare providers must provide a copy of the Medication Guide for the prescribed rosiglitazone medicine and review it with the patient or caregiver.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Adverse events involving rosiglitazone medicines should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  Please read the Drug Safety Communication for links to the REMS and background information detailing this communication.  A link to this DSC can be found at www.fda.gov/Drugs/DrugSafety.   If you have a drug question, you can reach us at druginfo@fda.hhs.gov.

 

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