Avandia (generic rosiglitazone), manufactured by GlaxoSmithKline, was approved in 1999 by the Food and Drug Administration to treat type 2 diabetes. It is estimated that approximately 6 million people take this drug all over the world. Avandia has been the world’s top-selling type 2 diabetes medication, with worldwide sales exceeding $3 billion in 2006.
The drug, when used with a healthy diet and exercise, is intended to improve blood sugar control in people with Type 2 diabetes. However, it has been discovered that the drug labeling is inadequate and does not mention relevant safety and efficacy information.
Side Effects Not Listed on Label
- Cardiovascular event
- Liver toxicity
- Weight gain
- Elevated lipids
- Low blood pressure
Black Box Warning
In June 2007, the FDA ordered Glaxo to carry a black-box warning, the most serious warning a prescribed drug can carry, due to the serious cardiovascular risks associated with the drug. The decision by the FDA commissioner was disclosed 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, 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.
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 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. After the FDA sent the warning letter to doctors, no other action was taken, and Avandia continued to be prescribed all over the world for years.
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.
Avandia’s 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.
If you, or someone you love, 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. Please call Colling Gilbert Wright at (407) 712-7300 or fill out our online contact form to set up your free consultation.