Safety Review of Avandia (Rosiglitazone)

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.
  • Online
  • Regular Mail: Use postage-paid, pre-addressed FDA form 3500
  • 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 alert 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 meeting of two of FDA's advisory committees.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: February 23, 2010

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