Posted: 04-05-10 Categories:
Avandia FDA Alerts

FDA Drug Safety Review of Avandia to be Completed by July 2010

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.
    • 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 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.

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