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The diabetes drug Avandia has been associated with a significanlty higher incidence of heart attacks and death, according to a major research analysis. Avandia, generically rosiglitazone and made by GlaxoSmithKline, was found to have a 43 percent greater risk of heart attack and a 64 percent increased risk of heart-related death.
The U.S. Food and Drug Administration issued a “black box” warning for Avandia on Oct. 14, 2007. The sternest of FDA warnings came after a close vote – reported as 8-7 – by an internal FDA committee on whether to keep Avandia on the market. (See stories below.) If you or someone you love suffered a heart attack or related death potentially associated with the use of Avandia, you may want to contact an Avandia attorney. The latest findings concerning Avandia and the risk of heart attack and death were the result of an analysis of 42 studies involving 15,560 patients who took Avandia and 12,283 who took other drugs or were given a placebo. The study was conducted by doctors at the renowned Cleveland Clinic and reported May 21, 2007 in The New England Journal of Medicine. (Read Article.) One of those who conducted the latest study, Steven Nissen, chairman of cardiology at the Cleveland Clinic, said it raised “serious concerns about the cardiovascular safety” of Avandia. (He advised that patients first consult with their doctor before discontinuing use of the medication.) The study was of particular concern since Avandia is taken by a patient population already prone to heart disease. Following release of the study, termed a "meta-analysis," the FDA issued the following warning: "Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia." The FDA said its own analysis of the drug was ongoing. (Read the FDA news release.) In addition, Congressional investigators were looking into what they termed “very serious” claims that Glaxo “silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia.” According to a report in The New York Times, one early critic of Avandia, Dr. John B. Buse, was “intimidated” by the drug company. As early as 2000, Dr. Buse, a diabetes specialist who is slated to become the next president of the American Diabetes Association, charged in a letter to the FDA that Glaxo had used “blatant selective manipulation of data” to overstate the benefits of Avandia and to understate its risks. (Full story.) Avandia, prescribed in pill form, is the most widely used oral diabetes treatment, with 2006 sales of $3 billion. It was approved in 1999 for the treatment of Type 2 diabetes – the most common form of diabetes -- and has since been taken by more than six million people worldwide. Some 21 million people in the United States suffer with diabetes. It occurs when the body does not produce enough of the hormone insulin or does not effectively use insulin to convert blood sugar into energy. Kline & Specter, P.C., with some 30 experienced attorneys, several of whom are also highly regarded doctors, is one of the nation's leading law firms with the ability to litigate pharmaceutical drug lawsuits. Contact an Avandia lawyer today.
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