The Food and Drug Administration FDA is reviewing data submitted in August 2009 from a large, long-term study on possible heart-related risks with the diabetes drug Avandia rosiglitazone. FDA’s review is ongoing. No new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time.

After FDA completes its review, the agency will hold a public meeting in July 2010 to present all the known heart-related safety data on rosiglitazone provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes

Advice for People Who Take Rosiglitazone

Don’t stop taking your medication without talking with your health care professional. Discuss any questions or concerns you have about rosiglitazone with your health care professional. Read the Medication Guide that comes with each rosiglitazone prescription to better understand the risks and benefits of your medication.

Report any side effects with rosiglitazone to FDA’s MedWatch program either online, by regular mail, by fax, or by phone.

• Online3
• Regular Mail: Use postage-paid, pre-addressed FDA form 35004
• Fax: 1-800-FDA-0178
• Phone: 1-800-332-1088

Brand Name Drugs Containing Rosiglitazone

Rosiglitazone is a medication used to treat type 2 diabetes mellitus. It is sold as a single-ingredient product under the brand name Avandia. It is also available in combination with other diabetes medications:

• metformin under the brand name Avandamet
• glimepiride under the brand name Avandaryl

Previous FDA Actions

FDA has been reviewing other studies of rosiglitazone on an ongoing basis as these studies are published. In 2007, FDA issued a safety alert5 about a possible association between rosiglitazone and increased heart-related risk. On July 30, 2007, FDA sought advice from experts outside of the agency at a joint meeting6 of two of FDA’s advisory committees.