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U.S. Department of Health and Human Services

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New Safety Information on Diabetes Drug Rosiglitazone

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Do not stop taking Avandia, Avandaryl or Avandamet without first talking to your doctor about this new information.

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Concerns are being raised about a possible increased chance of heart attack and heart-related deaths in patients taking rosiglitazone, an ingredient in three drugs used to treat type 2 diabetes: Avandia, Avandaryl, and Avandamet.

What Patients Should Do

If you are a patient taking rosiglitazone:

  • Do not stop taking Avandia, Avandaryl or Avandamet without first talking to your doctor about this new information.
  • Discuss the best individualized treatment plan for your diabetes and other medical conditions.
  • Remember that the best treatment plan is a team approach between you and your doctor.

There is agreement by several organizations that the overall level of risk appears to be small, but that the risk deserves serious attention and follow-up. They are:

  • American Association of Clinical Endocrinologists
  • American College of Cardiology
  • American Diabetes Association
  • American Heart Association
  • Endocrine Society

FDA agrees with these organizations and is conducting a thorough investigation.

What We Know

  • FDA and GlaxoSmithKline (GSK), the maker of rosiglitazone, have long recognized that use of drugs containing this ingredient may be associated with certain heart problems. This information has been included in the prescribing information for all rosiglitazone-containing products since 2001.
  • New information regarding fluid-related heart problems has been updated since 2001 and included in the prescribing information for all three drugs--most recently in 2006.
  • GSK combined the data from 42 clinical studies to look at the chance of other heart problems with rosiglitazone, analyzed the data, and submitted the results of this analysis to FDA, which is conducting its own analysis of these data.
  • These combined data raise the possibility of a new risk from rosiglitazone, related to the heart. This possible risk, while important, appears to be small.
  • There are over 14,000 people in these studies, and about 2/3 of them were treated with rosiglitazone.
  • Rosiglitazone is in a class of drugs called thiazolidinediones (TZDs). The other approved drug in this group is pioglitazone (Actos). These are two different drugs, and FDA is evaluating whether they have the same or different heart-related risks.
  • Swelling and fluid retention may occur with both drugs, so neither should be used in patients with troublesome heart failure.

What FDA is Doing

  • Conducting its own analysis of GSK's combined data, including a detailed review of the patient information from the 42 studies.
  • Considering the results of these data along with all other published and unpublished studies regarding rosiglitazone use and other diabetes drugs to determine the chance of heart problems.
  • Continuing to update the public as the agency receives new information, completes its analyses, and reaches conclusions based on those analyses.

Type 2 Diabetes:

  • Is a serious and life-threatening disease
  • Affects about 18 to 20 million Americans
  • Is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation
  • Is usually treated first with diet and exercise, and if they are not enough, FDA-approved medications, including metformin, sulfonylureas, thiazolidinediones, insulin, and several newer drugs, to lower blood glucose levels
  • Differs among each person, so treatment must be individualized.

Advisory Committee Meeting – July 30, 2007 (Open to the Public)

The Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet to discuss the cardiovascular ischemic and thrombotic (heart-related) risks of thiazolidinediones, focusing particularly on rosiglitazone (Avandia). 

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

Updated: June 18, 2007