Diabetic Drug Avandia Linked to Heart Attacks and Strokes
On May 21, 2007 the FDA issued an alert warning people with underlying heart disease are at an increased risk of heart attack or stroke while taking Avandia. On July 30, 2007, the FDA’s advisory committee concluded that the use of Avandia for treatment of Type 2 diabetes was associated with a greater risk of cardiovascular problems compared to a placebo. The FDA is now requiring GlaxoSmithKline, the maker of Avandia, to conduct a cardiovascular outcome trial on Avandia to provide a definitive answer to whether Avandia poses an unacceptable risk of cardiovascular disease.
Avandia has also been associated with other health risks including a greater risk of fractures in women as well as a higher risk for macular edema (swelling in the retina). In addition, Public Citizen, a consumer advocacy organization, has identified 14 cases of liver failure induced by Avandia, including 12 deaths.
The FDA has not recalled Avandia, but has required the drug to include a black box warning as of November 14, 2007. The warning states that people with underlying heart disease should be monitored closely while taking Avandia. If you believe you or a family member have suffered heart problems or a stroke while taking Avandia, please contact the Pintas Firm immediately. Consult your physician before discontinuing your medications.