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 this drug worldwide. Avandia is manufactured by GlaxoSmithKline and is the world’s top-selling Type 2 diabetes medication with worldwide sales exceeding $3 billion in 2006.
Black Box Warning
The FDA has asked the makers of Avandia to carry a black-box warning, the most serious warning a prescribed drug can carry, due to the cardiovascular risks associated with the drug. The decision by FDA commissioner, Andrew C. von Eschenbach, was disclosed Wednesday, June 6, 2007, more than one year after the agency’s safety reviewers strongly recommended such a step.
According to an article published in the New England Journal of Medicine on May 23, 2007, taking Avandia significantly increases the risk of heart attack in diabetes patients. After analysis of dozens of trials, it’s been concluded that Avandia increases the risk of heart attack by 43% and increases the risk of cardiac-related death by 64%. In response to this study, the FDA issued a public safety alert advising people taking Avandia to consult their doctors immediately regarding these cardiac risks.
Long History of Cardiac Concerns
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 a letter to GlaxoSmithKline stating the company’s sales representatives had been minimizing the drug’s safety concerns; the FDA asked Glaxo to send a letter to doctors prescribing the drug warning them of the serious cardiac risks associated with the drug. Dr. Buse’s letter to the FDA criticized Glaxo and accused the company of “pervasive and systemic” efforts to minimize the drug’s risks and overstate the drug’s benefits. After the FDA sent the warning letter to doctors, no other decisive action was taken, and Avandia continued to be prescribed all over the world for years.
So, apparently, the maker of Avandia and the FDA have known about the cardiovascular risks associated with the drug for over six years but have not adequately warned prescribing doctors and consumers about the deadly effects of the drug.
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. Plaintiffs’ lawyers will certainly latch onto the years of warnings about cardiovascular risk that were all but ignored by the drug giant, GlaxoSmithKline. The Chief Executive of the company, Jean-Pierre Garnier, has said it’s much too early to tell if Avandia will be the subject of lawsuits and is confident the safety of Avandia will be vindicated.
What You Can Do
If you or some one you loved was prescribed Avandia to treat Type 2 diabetes and subsequently suffered a cardiovascular event such as a heart attack, it is important that you seek competent legal advice as soon as possible.
Avandia manufacturer, GlaxoSmithKline, has known about the cardiovascular risks associated with the drug for almost seven years and has done nothing to protect the consumers from these risks.
The first step in pursuing the compensation you and your family deserve is to consult a pharmaceutical injury attorney in your area who has experience dealing with medical cases and with drug company litigation. He or she will evaluate your case and discuss your options with you.