The consumer advocacy group Public Citizen has filed a petition with the FDA calling for an Avandia recall as a result of a number of serious and potentially life threatening side effects associated with the diabetes drug.
Avandia (rosiglitazone), which is manufactured by GlaxoSmithKline PLC, was approved by the FDA in 1999 for treatment of type 2 diabetes.
The drug has been prescribed to millions of diabetics to help control blood sugar levels, but sales have fallen sharply over the past 18 months in response to reports that side effects of Avandia may increase the risk of heart attacks, congestive heart failure, liver failure, bone fractures, macular edema and death.
On October 30, 2008, Public Citizen filed a petition with the FDA calling for a ban on the drug. Although sales have dropped, the petition indicates that there are still approximately 10,000 prescriptions filled every day for the “unacceptably dangerous drug.”
Concerns about the potential Avandia heart side effects first emerged in May 2007 in a report published by the New England Journal of Medicine, which indicated that users may face a 43% increase in the risk of a heart attack. Some estimates have suggested that as many as 100,000 heart attacks among Avandia users may have been caused by the drug since it was first approved.
In their petition, Public Citizen points to new evidence that strengthens the association between use of Avandia and liver failure. The group identified 14 cases of liver failure, including 12 deaths, associated with Avandia in the FDA Adverse Event Reporting System.
“The scientific consensus against Avandia is overwhelming,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “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.”
Public Citizen is an advocacy group that represents over 80,000 U.S. consumers. The Health Research Group of Public Citizen provides information on drugs, medical devices, doctors, hospitals and healthcare options in order to educate consumers about available services and take action against ineffective and unsafe drugs and devices.
In previous petitions, Public Citizen asked the FDA to add a black box warning about the risk of tendon ruptures with Levaquin, Cipro and other fluoroquinolone antibiotics. That petition was filed two years before the drug makers and the FDA required the stronger warnings to protect consumers.
The Public Citizen petition for an Avandia recall comes one week after the American Diabetes Association and the European Association for the Study of Diabetes dropped the drug from their consensus statement on type 2 diabetes treatment, unanimously recommending against use of the drug.
It is unclear what response the FDA will have to the petition and whether they will take the requested action.
GlaxoSmithKline PLC currently faces hundreds of Avandia lawsuits filed by users who have suffered heart attacks, strokes, liver failure, congestive heart failure, bone fractures, vision loss and death.