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The U.S. Food and Drug Administration (FDA) issued a safety alert today concerning the drug Avandia (rosiglitazone), which was approved by the FDA in 1999 as a treatment for type 2 diabetes, a serious disease that affects approximately 18 to 20 million people in the U.S. It is estimated that tens of millions of Avandia prescriptions have been written in the U.S. since its introduction.
Potential Increased Risk for Heart Attack and Other Problem
Recent published and unpublished clinical data suggest that the use of Avandia may result in a significant increase in the risk of heart attack, stroke, and heart-related mortality. The FDA stated that patients who are being treated with Avandia should talk to their physicians about the new safety information regarding this medication. However, the FDA noted that there is an inherent risk in switching from one diabetes treatment to another, and that physicians and patients should make individualized decisions regarding treatment.
Warnings on the Avandia Labeling
Patients with diabetes are already at an increased risk of heart disease. Since Avandia’s approval, the FDA has updated the drug’s labeling several times to provide information about its potential associated risk of adverse heart-related events (congestive heart failure, fluid retention, and edema, among others). The latest labeling change will include a new warning about the potential increased risk of heart attack and chest pain observed in some patients treated with Avandia.
FDA Advisory Committee to Convene Regarding Avandia
Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, stated that "The FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened." The maker of Avandia, GlaxoSmithKline, has not yet been asked to take any action regarding Avandia by the FDA.
(Source: FDA; http://www.fda.gov/)
Has Avandia treatment harmed you or a loved one? Contact an experienced attorney to discuss your legal rights. You may be eligible for financial compensation for losses based on medical bills, income and earning capacity loss, pain and suffering, and more.