Avandia Safety Information

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Avandia can cause or worsen heart failure, and is not recommended if you have heart failure with symptoms, even if these symptoms are not severe.

*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

  • In patients already being treated with these medicines
  • In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

What’s the problem?

Avandia may increase your risk of heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

If you have chest pain or a feeling of chest pressure, seek immediate medical attention regardless of what diabetes medication you are taking. If you take Avandia, tell your doctor right away if you have: swollen legs or ankles, experienced rapid weight gain, have difficulty breathing, unusual tiredness, changes in vision, or become pregnant.

Before Taking Avandia

Review your medical history and tell your doctor if you:

  • Have heart failure or other problems
  • Are on any medications for high blood pressure, high cholesterol, or heart failure.
  • Take insulin or nitrate medications. Taking Avandia with insulin or with nitrates is not recommended.
  • Have macular edema
  • Have liver problems or have had liver problems while taking Rezulin.
  • Are pregnant or planning to become pregnant.
  • Are breastfeeding or planning to breastfeed.
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