Advocacy Group Wants Ban On Avandia
On October 30, 2008, the consumer group Public Citizen asked the FDA to ban GlaxoSmithKline PLC’s problematic diabetes drug Avandia over safety concerns. The move follows updated practice guidelines released last week by the American Diabetes Association and the European Association for the Study of Diabetes that recommend doctors not use the drug.
Avandia’s safety record has been gloomy since an analysis of studies released last year suggested it was linked to an increase in heart attacks. In November the FDA strengthened a black-box warning on Avandia telling doctors the product was linked to a potential increase in heart attack risk.
The agency said the drug would remain on the market while a safety assessment continues. FDA officials have said there’s been a split within the agency about whether to pull Avandia off the market or allow it to stay on the market with stronger warnings.
In a petition filed with the FDA, Public Citizen said that in addition to the heart risks it identified 14 cases of Avandia-induced liver failure, including 12 deaths after a review of adverse-event reports filed with FDA. In a statement, GlaxoSmithKline said 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.” The company said Avandia was safe and effective when used appropriately.
The FDA didn’t immediately return a request for comment on the petition.
Sales of Avandia have fallen sharply since the safety questions surfaced last year, but Public Citizen said about 10,000 prescriptions are still being filled a day for Avandia.
An estimated 20 million Americans have Type-2 diabetes, a disease characterized by high blood-glucose levels that result from the body’s inability to use insulin. Insulin, produced by the pancreas, is needed to take sugar from blood into cells.
Drugs such as Avandia, and a similar drug Actos by Takeda Pharmaceutical Co., are designed to make the body more sensitive to insulin in order to help lower blood sugar. Other drugs used to treat diabetes include sulfonylurea drugs, which work to stimulate the pancreas to release insulin, and metformin, which works on the liver to reduce blood sugar. Diabetes itself increases the risk for cardiovascular disease, kidney disease, blindness and amputations.
The FDA approved Avandia for use in treating Type-2 diabetes in 1999. Although Actos is similar to Avandia it has not been linked to a possible increase in heart attacks. Both drugs carry a warning about increased risk of heart failure or the inability of the heart to properly pump blood.
