FDA is reviewing RECORD study Avandia heart risks data submitted in August 2009 – FDA Drug Safety Assessment of Avandia to be released July 2010
[02-23-2010] 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.
- 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 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.