Public Citizen is petitioning the FDA for an immediate ban of the drug Avandia because it can cause death from liver failure and many other life-threatening risks that far outweigh its benefits.
Avandia is a drug manufactured by GlaxoSmithKline and prescribed by doctors for the treatment of Type 2 Diabetes and is also known by its generic name, rosiglitazone or rosiglitazone maleate.
While reviewing U.S. Food and Drug Administration data, the group found 14 unpublished cases of severe drug-induced liver failure, including 12 deaths.
That risk, along with other well known health complications associated with Avandia including heart failure, bone fractures and vision loss, was too great to allow marketing of the drug to continue in the United States, especially when other, safer treatments are available, it said in a petition to the FDA.
“The scientific evidence against Avandia is staggering,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “These findings should give the FDA the push they need to act quickly to prevent any further needless deaths and health damage caused by this drug.”
Public Citizen’s call for an FDA ban on Avandia comes just as an American Diabetes Association/European Association for the Study of Diabetes working group advised against use of the drug.
Avandia use plunged dramatically from 13.2 million to 4.6 million after a study published in the New England Journal of Medicine, May 2007, linked the drug to an increase heart attack risk.
Public Citizen estimates that nearly 10,000 prescriptions are still being filled on a daily basis. "Therefore, it is urgent for the FDA to immediately ban Avandia," it said.
Safer, more effective diabetes drugs include: Glucophage (generic name metformin) and Glucotrol (generic name glipizide). Actos, should be avoided because it shares many, if not most, of Avandia’s same toxicities.
In another study, researchers at Johns Hopkins Bloomberg School of Public Health found metformin, helped to decrease heart disease and other heart-related deaths.
GlaxoSmithKline sharply defended its drug, saying its own review by an independent panel earlier this year said the liver risks were acceptable.
The U.S. Centers for Disease Control and Prevention released a recent report that found nearly 24 million Americans are afflicted with diabetes, an overwhelming increase of 15 percent in two years.
An estimated 8 percent of people in the U.S. have type-2 diabetes which can be associated with poor diet, obesity, and lack of exercise.
Diabetes is the seventh-leading cause of death in the United States.
An FDA advisory panel, in July, said drugs designed for treatment of type 2 diabetes should be subjected to stricter safety reviews to ensure their safety. They also recommended that all diabetes drug makers should conduct long-term cardiovascular studies, even if the drugs’ showed no signs of heart problems during initial trials. #