Diabetes Drug Linked to Serious Heart Risks
Avandia, generic rosiglitazone, was approved in 1999 by the FDA (Food and Drug Administration) to treat type 2 diabetes. It is estimated that approximately six million people take the drug worldwide to treat type 2 diabetes. An article published in the New England Journal of Medicine in late May 2007 states that taking Avandia significantly increases the risk of heart attack in diabetes patients. In response to the article, the FDA issued a public safety alert advising people taking Avandia to consult their doctors regarding the cardiovascular risks associated with taking the drug.
After analysis of dozens of trials, it has been concluded that Avandia increases the risk of heart attack by 43% and cardiac-related death by 64%.
GlaxoSmithKline, the maker of Avandia, issued a news release defending themselves and the drug. Glaxo is challenging the data presented in the New England Journal of Medicine study stating that it is too soon draw the conclusion that Avandia increases the risk of cardiovascular problems in type 2 diabetes patients.
However, back in 2000, Dr. John B. Buse, Chief of Endocrinology at the University of North Carolina at Chapel Hill, wrote a letter to the FDA warning that Avandia showed “a worrisome trend in cardiovascular deaths and severe adverse events″ among patients taking the drug. In July 2001, the FDA sent Glaxo a letter stating the company′s sales representatives had minimized the drug’s safety concerns the FDA asked Glaxo to send a letter to doctors who prescribe Avandia warning them of the serious risks involved with taking the drug.
Apparently both the FDA and the maker of Avandia have known about the potential cardiovascular risks associated with drug for over six years but have not adequately warned prescribing doctors and consumers about the deadly effects of the drug. Back in 2000, Dr. Buse’s letter to the FDA criticized Glaxo and accused the company of “pervasive and systemic” efforts to minimize the drug’s benefits and overstate the drug’s benefits. The FDA sent a warning letter to physicians, but no more decisive action was taken, and the drug continues to be prescribed all over the world.
Lawyers for Glaxo said they are already getting calls from Avandia users and predict future lawsuits could run into the tens of billions of dollars. Plaintiff lawyers will surely latch onto the years of warnings about cardiovascular risk that were all but ignored by the maker of Avandia.
If you or a loved one has taken Avandia for type 2 diabetes and suffered cardiovascular symptoms as a result, you may be entitled to compensation in the future. If you live in the Denver area or anywhere in Colorado, please contact experienced brakelaw.com/dangerous_drugs.html Dangerous Drugs Attorney Andrew T. Brake, P.C. today to find out if you have a legitimate Avandia injury claim.