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AVANDIA may cause heart attacks and heart failure.
Andrews & Thornton are investigating cases to determine whether there is sufficient evidence to link heart attacks and heart failure to use of Avandia. Avandia (rosiglitazone maleate) was approved by the FDA in 1999 for treatment of type 2 diabetes. Diabetes is a serious disease. Safe and effective treatments are very important to the public health. Avandia was heavily promoted by GlaxoSmithKline (GSK) as a new and improved medicine to lower blood sugar.
Early concerns about heart safety It has recently come to light that the FDA approval was against the objections of the primary medical reviewer. The reviewer after examining the data concluded that Avandia should not be approved without further study, because of disturbing danger signal that the drug caused heart problems. This recommendation was overridden with pressure from the manufacturer. Though further studies are being conducted they are not designed to primarily target the question of cardiac safety.
New cause for concern:
One of the nations foremost cardiologists, Steven Nissan with colleagues from the Cleveland Clinic looked at all of the data from the studies of Avandia and found that there was evidence of an increase in heart attacks in people using the drug. On May 21, 2007, the New England Journal of Medicine published a meta-analysis of 42 clinical trials finding that diabetes patients taking Avandia experience 43% more heart attacks than those not taking the drug.
On May 21, 2007 The FDA issued a safety alert on Avandia.
http://www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm
The FDA is conduction an ongoing review of the safety of Avandia. In conjunction with the safety issue, there are new questions about both the cost and effectiveness of Avandia. An independent review by Consumer Union, disclosed that older cheaper diabetes drugs are safer and more effective.
http://www.crbestbuydrugs.org/PDFs/type2diabetes.pdf
If you would like to speak to an experienced attorney concerning a possible Avandia case, contact
Andrews & Thornton.
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