• image.alt
  • With Mayo Clinic endocrinologist

    Maria Collazo-Clavell, M.D.

    read biography

Free

E-Newsletters

Subscribe to receive the latest updates on health topics. About our newsletters

  • Housecall
  • Alzheimer's caregiving
  • Living with cancer

Question

Avandia safety concerns: What should I do?

I've heard the news that the Food and Drug Administration has restricted the use of Avandia. I currently take this drug — what do I do?

Answer

from Maria Collazo-Clavell, M.D.

If you're currently taking or considering the drug, Avandia, the news regarding the Food and Drug Administration's (FDA's) increased restrictions on Avandia should prompt you to talk with your doctor about what's best for you as soon as possible. Avandia will no longer be available in retail pharmacies as of November 2011.

Avandia — which belongs to a class of drugs known as thiazolidinediones — is one of many oral medications designed to control blood sugar in those with diabetes. Avandia lowers the amount of sugar in your blood by making your tissues more sensitive to insulin, a hormone that regulates the absorption of sugar into your cells.

Avandia has been linked to serious risks, including the FDA's primary concern — an increased risk of heart attack.

Initial FDA restrictions still allow the use of Avandia if:

  • You're already taking Avandia and have determined with your doctor that the benefits of the medication outweigh the potential cardiovascular risks for you.
  • You're unable to take or control your blood sugar with other medications and have determined with your doctor that the benefits of Avandia outweigh the potential cardiovascular risks for you.

The FDA requires your doctor to provide you a copy of the Avandia medication guide and review it with you. The FDA also requires that you and your doctor enroll in a program — the Avandia-rosiglitazone Medicines Access Program — to be able to receive and prescribe this medication. After November 18, 2011, you'll no longer be able to obtain Avandia at retail pharmacies. It will only be available to you by mail, from pharmacies enrolled in the program.

If Avandia is part of your diabetes treatment plan, continue taking the drug as prescribed until you have the opportunity to talk to your doctor. Although an increased risk of heart attack is nothing to take lightly, the risk isn't considered an emergency. It's much riskier to stop taking a diabetes medication on your own.

Next question
After a flood, are food and medicine safe to use?
References
  1. Collazo-Clavell ML (expert opinion). Mayo Clinic, Rochester, Minn. Sept. 24, 2010.
  2. Avandia (rosiglitazone): REMS — Risk of cardiovascular events. Food and Drug Administration. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994. Accessed Sept. 27, 2010.
  3. FDA drug safety communication: Updated risk evaluation and mitigation strategy (REMS) to restrict access to Rosiglitazone-containing medicines including Avandia, Avandamet, and Avandaryl. Food and Drug Administration. http://www.fda.gov/Drugs/DrugSafety/ucm255005.htm. Accessed May 18, 2011.
AN02125 May 21, 2011

© 1998-2012 Mayo Foundation for Medical Education and Research (MFMER). All rights reserved. A single copy of these materials may be reprinted for noncommercial personal use only. "Mayo," "Mayo Clinic," "MayoClinic.com," "EmbodyHealth," "Enhance your life," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation for Medical Education and Research.

  • Reprints
  • Print
  • Share on:

  • Email

Advertisement


Text Size: smaller largerlarger