In May 2007, the New England Journal of Medicine published an article citing that patients using the diabetes drug Avandia (rosiglitazone maleate) face an increased risk of Avandia side effects such as heart attack or heart-related death.
This is especially troubling news for diabetics, who are already at an increased risk of heart attack. In addition, the ADOPT study (released in late June 2007) showed that women who take Avandia are at an increased risk of suffering bone fractures.
Avandia received Food and Drug Administration approval in June 1999 as a treatment for type 2 diabetes.
Fluid retention, bad cholesterol—and more
Although there was evidence that Avandia could cause fluid retention and a rise in “bad” cholesterol—two risk factors for heart problems—the FDA allowed Avandia to be marketed and sold, despite getting just a six-month review.
Doctors have written about 60 million Avandia prescriptions since GlaxoSmithKline put it on the market, including more than 13 million last year.
The authors of the NEJM article pooled the records of 28,000 patients involved in 42 clinical trials for Avandia. Patients taking Avandia were 64% more likely to die from heart problems and 43% more likely to suffer a heart attack than patients who were given another drug or a placebo.
In total, 158 patients involved in the Avandia clinical trials suffered a heart attack, and 61 people taking Avandia died.
Because most of the studies analyzed lasted only a few weeks, the risk of Avandia side effects may be much higher, according to Dr. Steven Nissen of the Cleveland Clinic, lead author of the NEJM study.
The FDA’s response
Based on the research of Dr. Nissen and his colleagues, the FDA has announced plans to conduct a more detailed examination of Avandia side effects.
Within two weeks of the publication of Dr. Nissen’s research, the agency ordered a “black-box” warning for Avandia’s label.
The agency is urging patients to speak with their doctors about other options for treating their diabetes symptoms, but it currently has no plans to issue an Avandia recall. That may change as the number of Avandia lawsuits grows.Read More