A study published in the May 2007 issue of the New England Journal of Medicine found that the diabetes medication Avandia (rosiglitazone maleate) increases the risk of death from heart problems by 64%.
The study also found a 43% increase in heart attacks among Avandia users. Less than two weeks after the publication of the article, the Food and Drug Administration imposed a “black-box” warning on Avandia’s label.
The next month brought more bad news for Avandia in the form of the ADOPT study. This multicenter, randomized, double-blind clinical trial involving 4,360 patients showed that the drug raises the risk of bone fractures for women who take it.
Avandia increases the risk of death from heart problems by 64%.
The FDA called for a second black box warning to be added to Avandia's label in November 2007. This second warning was designed to alert patients that Avandia could increase their risk of heart attacks or chest pain.
Approved in 1999
Avandia, manufactured by GlaxoSmithKline, was approved by the FDA in 1999 to treat type 2 diabetes, the most common form.
Type 2 diabetes occurs when the body does not make enough insulin or cannot use what it produces. Avandia sensitizes the body to insulin, allowing it to make better use of what it produces.
Although there were indications at the time of its approval that Avandia could cause fluid retention and a rise in “bad” cholesterol—both risk factors for heart problems—the FDA gave the drug its OK after a priority review of less than six months.
About 60 million prescriptions for Avandia have been written since 1999, including 13 million last year alone.
Dr. Nissen’s meta-analysis of Avandia
The NEJM article pooled the results of 42 studies of more than 28,000 patients, revealing that the risk of death from heart problems was 64% greater among those who were given Avandia. Patients were also 43% more likely to suffer a heart attack while taking Avandia. A total of 158 patients in the trials suffered this Avandia side effect, and there were a total of 61 deaths.
Dr. Steven Nissen, lead author of the study, says that because many of the studies lasted just a few weeks, the actual risk of Avandia side effects may be much higher than what was indicated in the article.
The FDA is planning to convene an advisory committee to analyze the risk of Avandia side effects. The agency currently has no plans to issue an Avandia recall, but it advised patients to speak with their doctor to discuss other treatment options.
If you have been injured as a result of Avandia side effects, you may wish to find out more about filing an Avandia lawsuit. To speak with an attorney about your case, you can contact Sam Levine by calling toll-free (888) 404-LAWYER or by filling out our contact form.
