The diabetes drug <"http://www.yourlawyer.com/topics/overview/avandia">Avandia has been linked to so many health problems that some have questioned whether or not it should be on the market at all.
In November 2007, a warning detailing Avandiaâ€™s association with myocardial ischemia was added to the drugâ€™s boxed warning. The warning followed an analysis of 42 clinical trails published by the Cleveland Clinic in May 2007 that found patients taking Avandia had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia.
Since then, concerns about Avandia have only grown. Another study involving 30,000 diabetic patients published in the November 24, 2008 issue of The Archives of Internal Medicine found elderly Avandia patients were at higher risk of death than people taking other diabetes medication All of the patients in the study were over 65; 49.7 percent of these patients had been prescribed Avandia and 50.3 percent were treated with Actos. Within a year 1,869 of the patients had died. Among the patients who had been prescribed Avandia, the rate of death was 15 percent higher than in those prescribed Actos.
This past July, a study known as RECORD found that Avandia â€œsignificantlyâ€ raises the risk of heart failure and fractures. But unlike previous research, this study did not find that people taking Avandia were at a higher risk of heart death, and was unable to determine if the Avandia patients in the study had a higher chance of heart attack. The RECORD study involved 4,447 patients with type 2 diabetes, randomly selected to take Avandia plus metformin and sulfonylurea or just metformin and sulfonylurea.
RECORD, however, was not a blinded study, and it did cause some controversy because it was paid for by Glaxo. As we reported at the time, Dr. Stephen Nissen, who conducted the 2007 Cleveland Clinic study, said RECORD was “seriously flawedâ€ because more patients in the Avandia group were taking cholesterol-lowering statins and that group had what looked to be a high drop-out rate.
In October 2008, the group Public Citizen said it had identified 14 cases of Avandia-induced liver failure in the FDAâ€™s Adverse Event Reporting System. Of the 14 cases of liver failure, 12 resulted in deaths. Those findings prompted Public Citizen to file a petition with the FDA asking that Avandia be removed from the market.
In a press release announcing the petition, Public Citizen encouraged diabetes sufferers to avoid taking the drug because it increases the risk of heart attack approximately 40 percent, doubles the risk of heart failure and bone fractures, and increases the risk of anemia and vision loss from macular edema, a swelling of the retina caused by fluids accumulating in the eye. There were 39 times more reports of macular edema per million prescriptions filled for Avandia than for an older diabetes drug, glipizide, the group said,
Avandia was first sold in the U.S. in 1999, and became a blockbuster for GlaxoSmithKline, quickly becoming its biggest selling product. By 2006, Avandia’s total sales were $3.4 billion.