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.
So far, about 13,000 patients have filed Avandia lawsuits after allegedly suffering heart attack or other side effects from the drug.
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.
In July 2010, an FDA advisory panel voted to either withdraw Avandia from the market or place new restrictions on who can take the drug. The agency announced that it will release a decision “as soon as possible” on whether to issue an Avandia recall or to issue new warnings for the drug.