Avandia Lawsuits
Avandia was surrounded by controversy not long after winning FDA approval in 1999.
Early side effects of the drug included weight gain, which often means trouble for a type 2 diabetic. Soon, more serious side effects of Avandia became apparent—including liver problems, anemia, cardiovascular problems, high cholesterol, low blood pressure and respiratory problems.
These matters were such a concern that by 2000, the FDA was being petitioned to include a warning about side effects on the product labeling of Avandia.
In August 2007, the FDA called for a “black-box” warning to be added to Avandia’s label, warning patients that the diabetes medication could increase their risk of congestive heart failure.
That November, the agency called for a second black box warning to alert patients of the increased risk of heart attack or chest pain they could face by taking Avandia.
The FDA is currently reviewing whether to recall Avandia or to place new restrictions on who can be prescribed the drug.
Full Avandia side effects risk still unknown
The full extent of the side effects are unknown, but a study in the May 2007 issue of the New England Journal of Medicine showed Avandia’s link to a heightened risk of heart attack. Soon after, the FDA hit Avandia with a “black-box” warning. More bad news came in the ADOPT study, a big clinical trial which proved that women who take Avandia are at an increased risk of suffering bone fractures.
About 13,000 patients have already filed lawsuits over the side effects they suffered after taking Avandia. Avandia lawyers continue to file new lawsuits over patients who have suffered heart attack, stroke or other side effects of the drug.