AVANDIA

AVANDIA
Generic name: Rosiglitazone
Date Approved: May 25, 1995
Manufacturer: GlaxoSmithKline
Status: On the market, December 2005 manufacturer warning letter, January 5, 2006
FDA and manufacturer warning
Approved Uses: Type 2 diabetes

Serious Side Effects:
Swelling of the feet
Hepatitis
Edema
Congestive heart failure
Death

Avandia, manufactured by GlaxoSmithKline, was approved by the FDA on May 25, 1995. It is the best-selling oral diabetes treatment in the world. Avandia increases the body’s sensitivity to insulin, lowering blood sugar. Avandia is only approved to treat type II diabetes, and those with type I diabetes (juvenile diabetes) or diabetic ketoacidosis should not take the drug.

The New England Journal of Medicine issued a report that patients taking Avandia were 43 percent more likely to have a heart attack. As a result, the FDA issued a saftey alert on the drug. Furthermore, a study conducted by Mayo Clinic Proceedings on September 9, 2003 on sixmen between the ages of 66 and 78 years of age showed six cases of congestive heart failure after consistent use of Avandia. All six patients experienced shortness of breath, weight gain, and swelling of their feet. Four of the six subjects developed chronic renal insufficiency, or abnormally functioning kidneys.

The FDA has updated Avandia’s labeling several times since approval as new risks have been discovered. The most recent change occurred in 2006 when side effects such as chest pain and increase in heart attacks became evident.

Avandia’s effects on the liver have not yet been determined. It is in the same class of drug as Rezulin, which is associated with rare instances of serious liver injury. Before taking Avandia your doctor should preform blood tests to evaluate your liver condition, and conduct additional tests every 2 months the first year on the drug and regularly there after. If you begin to experience vomiting, nausea, loss of energy and appetite, dark uring, stomach pain, or yellowing of the skin seek medical attention as these are symptoms of liver complications.

If you or a loved one has been injured by Avandia contact the law offices of Keller & Keller LLP for a free consulation. We will hold negligent companies responsible and fight to seek just compensation for you injuries.

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