The Food and Drug Administration has announced that it would withdraw Avandia from sale in US retail stores beginning in November 2011. Patients taking Avandia may face an increased risk of heart attack or stroke, according to a statement by the agency.
Concerns about the safety of Avandia first arose in 2007, when a study published by the New England Journal of Medicine found that Avandia users were at an increased risk of suffering from a heart attack or dying from heart problems. According to the study patients taking Avandia were 43% more likely to suffer heart attack and 64% more likely to die of heart problems than patients taking another diabetes drug or a placebo.
The authors of the NEJM article pooled the records of 28,000 patients involved in 42 clinical trials for Avandia. In total, 158 patients involved in the Avandia clinical trials suffered a heart attack, and 61 people taking Avandia died.
The FDA’s decision to restrict sales of Avandia followed the recommendations of its advisory panel, which, in September 2010, voted that the agency should issue an Avandia recall or severely limit the number of patients who can take the drug.
Thousands of former patients have already filed lawsuits after suffering heart attack, stroke or other heart problems after taking Avandia. These lawsuits have alleged that GlaxoSmithKline—the manufacturer of the diabetes drug—failed to properly warn patients about the side effects of Avandia.
If you or a loved one took Avandia and suffered heart attack, stroke or other side effects, contact the lawyers at Hissey Kientz to learn more about your legal rights. You can reach us by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form to the right of this page.