Safety Alerts & Recalls
What does this mean?
This safety alert is an update on the status of the recently announced FDA restrictions for rosiglitazone-containing medicines. You may continue to take a rosiglitazone-containing medicine (Avandia, Avandamet, or Avandaryl) as directed by your healthcare professional. However, it is important that you understand the risks and benefits of your medicine. You can read the Medication Guide you get along with your rosiglitazone-containing medicine. It explains the risks associated with the use of rosiglitazone. Be sure to talk to your healthcare professional if you have concerns about rosiglitazone-containing medicines.
Any adverse reactions you experience with Avandia, Avandamet, or Avandaryl may also be reported to the FDA's MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
FDA Update: Avandia, Avandamet and Avandaryl Labels Now Include Information About Heart-Related Risks, Patient Access Restrictions Expected Later This Year
The U.S. Food and Drug Administration (FDA) is notifying the public that the prescribing information and patient Medication Guide for the diabetes drug rosiglitazone has been updated to include information on heart-related risks, including the risk of heart attack, associated with this medicine. This safety information was first announced by FDA on September 23, 2010. 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).
In addition to describing the heart-related 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 medicine
-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 (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
At this time, FDA has only approved these safety-related changes to the prescribing information and Medication Guides for the rosiglitazone-containing medicines. The program to restrict the availability of rosiglitazone-containing medicines has not yet been approved and formally implemented. The FDA will be providing further information on this program in the coming months. FDA expects to approve the program by Spring 2011, and for the manufacturer to complete implementation 6 months thereafter.
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