Public Citizen's calls for ban on Diabetes Drug Avandia
Advocacy group Public Citizen said GlaxoSmithKline PLC's diabetes drug Avandia should be banned in the United States as it can cause death from liver failure and has other life threatening risks which are more than the benefits itoffers.
The American Diabetes Association and the European Association for the Study of Diabetes issued guidelines which said that members of a joint medical panel "unanimously advised against using" Avandia.
The drug already carries a “black box” warning of its increasing the risk of heart attacks and now the Public Citizen group asked the U.S. Food and Drug Administration to ban the drug citing the drug induced liver failure in 14 cases. 12 of these have resulted in liver related death.
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, in a Public Citizen news release said, "The scientific evidence against Avandia is overwhelming. The timing of these findings should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug."
According to Public Citizen, the drug Avandia increases the risk of heart attack by about 40%, 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 fluid accumulation in the eye.
A report published in the New England Journal of Medicine in May 2007 linked the drug to increased heart attack risk which led to a decline in the drugs sale from 13.2 million in 2006 to 4.6 million last year.
GlaxoSmithKline in a statement said that it had not yet looked at the petition but said that "we do not believe there is a connection between liver toxicity and this medicine." Avandia was safe and effective when used appropriately, the company added.
An estimated 20.4 million Americans have type 2 diabetes, which can lead to kidney failure, blindness and heart disease. About 75 % of diabetics die from cardiovascular disease.
The FDA approved Avandia in 1999 and has said it will review the petition carefully. The FDA is said to be split on whether the drug should be pulled off the market or allowed to stay with stricter warnings about adverse effects.