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FDA Drug Safety Podcast for Healthcare Professionals: Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients

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Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information.  On February 3, 2011, the Food and Drug Administration issued a Drug Safety Communication notifying the public that information on the cardiovascular risks (including heart attack) of the diabetes drug rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.

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, which contains rosiglitazone and metformin, and under the brand name Avandaryl, which contains rosiglitazone and glimepiride.

In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

  • In patients already being treated with these medicines, or
  • In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines such as Actos, Actoplus Met, Actoplus Met XR, or Duetact.

At this time, FDA has only approved these safety-related changes to the physician labeling and Medication Guides for the rosiglitazone-containing medicines. The Risk Evaluation and Mitigation Strategy, or REMS, which will restrict rosiglitazone-containing medicines' availability, has not yet been approved and formally implemented.

FDA will be providing further information on this REMS program in the coming months. FDA expects to approve the REMS by Spring 2011, and for the manufacturer to complete implementation 6 months thereafter.

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

  1. The REMS for rosiglitazone-containing medicines does not take effect at the time of this announcement. You may continue to prescribe and dispense rosiglitazone-containing medicines as directed in the revised drug label.
  2. You should begin discussing the risks and benefits of taking rosiglitazone-containing medicines versus other therapies with your patients, and make decisions about optimal treatment for your individual patients.
  3. Patients should be encouraged to read the rosiglitazone Medication Guide given to them when they pick-up their prescription at the pharmacy.
  4. Adverse events involving rosiglitazone-containing 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.  To learn more about this Drug Safety Communication, go to www.fda.gov/Drugs.  If you have drug questions, you can reach us at: druginfo@fda.hhs.gov.


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