Safety Alerts & Recalls
What does this mean?
Heart attack, stroke, and heart failure are well known risks of Avandia. The risk of heart attacks and new or worsening heart failure is described in a Black Box Warning for Avandia and the combination products of Avandamet and Avandaryl. While the FDA continues its review of the safety of Avandia, it will remain available to the public.
For patients taking Avandia, or a combination product such as Avandamet or Avandaryl, controlling your diabetes is important and you should not stop taking your medication without first talking with your doctor or other healthcare professional. This alert is a good reminder to regularly review the benefits and risks of your medicines with your doctor. At your next doctor's appointment, you may wish to review how well your current diabetes treatment is working (the benefits) and discuss any concerns about side effects and long-term risks.
If you have any additional questions about Avandia or a combination product like Avandamet or Avandaryl, please follow up with your doctor or other healthcare professional.
Two New Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems: FDA Safety Review Ongoing
Two major studies have found the medicine Avandia (rosiglitazone) could increase the risk of having a heart attack and other serious problems including strokes, heart failure, and death. These studies were published this week in the medical journals Archives of Internal Medicine and the Journal of the American Medical Association (JAMA).
The FDA has been conducting an ongoing safety review of Avandia and the risks of heart attack, stroke, and heart failure for several months. No new conclusions or recommendations about the use of Avandia in the treatment of type 2 diabetes have been made at this time. An FDA advisory committee of experts will meet in July 2010 and review these new studies plus others. At that meeting, the Advisory Committee will provide an updated assessment of the risks and benefits of Avandia in the treatment of type 2 diabetes.
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