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The U.S. Food and Drug Administration (FDA) has announced it will require tougher warnings about heart failure for Avandia®, a drug used to treat type 2 diabetes.The FDA is ordering GlaxoSmithKline to add a “black box” warning to Avandia®, strengthening existing warnings about a condition in which the heart does not adequately pump blood. The issue is separate from a study that said Avandia® increased the risk of a heart attack.

That study, published in the New England Journal of Medicine, showed a 43 percent increase in heart attacks in people using Avandia®, as well as a significant increase in the risk of heart-related deaths. In addition to these heart complications, Avandia® has been tied to PPH, visual abnormalities including macular edema (swelling of part of the retina) and increases in several kinds of fractures in women. In addition, there have been reports of anemia, which also increases the risk for a heart attack.

Adverse Effects associated with Avandia®:

* Heart Attack


* Cardiovascular Conditions

* Congestive Heart Failure (CHF)

* Bone Fractures

* Macular Edema


Avandia®, manufactured by GlaxoSmithKline, was approved in 1999 for treatment of type 2 diabetes, a disease that affects about 18 to 20 million Americans. Since the drug was approved, the FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure). Meanwhile, 11 million prescriptions were filled for the drug in the United States in 2006 alone. There is now evidence surfacing that the manufacturer has known the dangers of Avandia® for several years and has said nothing.

Patients who are taking Avandia®, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their diabetes.

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