FDA Recall Rejection Will Mean More Avandia Heart Attacks: Public Citizen

Federal drug regulators have rejected a petition filed by the prominent consumer advocacy group Public Citizen, which called for an Avandia recall to be issued.

As a result, Public Citizen suggests that allowing the medication to remain on the market, even with restrictions recently put in place, will result in more heart attacks from Avandia and other health problems among those taking the diabetes drug.

Public Citizen petitioned the FDA to remove Avandia from the market on October 30, 2008. More than three years later, the FDA informed the group on Monday that it was rejecting the petition and allowing Avandia to stay on the market despite the risk of serious and often fatal side effects of Avandia. 

The decision comes as no surprise, as the FDA announced last year that Avandia will remain on the market with severe restrictions on use, including limitations on where the medication can be obtained and requring a special eductation program before the drug can be prescribed. However, Public Citizen indicates that the Avandia restrictions are not enough.

The European Medicines Agency (EMA) banned Avandia in September 2010, after determining that effective restrictions to reduce the risk of injury could not be identified. Avandia has also been banned in New Zealand, India and other countries.

In a scathing response to the FDA recall rejection posted on Public Citizen’s website, the group pointed out that approximately 1.1 million prescriptions for Avandia-containing drugs have been filled in the United States since September 2010, which will likely cause hundreds of additional heart attacks and cases of severe heart failure.

“The FDA’s decision not to ban the drug but to limit prescriptions for the drug, so that patients will have allegedly tried other treatments first, is a dangerous and reckless refutation of the precautionary principle that is supposed to guide decisions involving public health,” said Dr. Sydney Wolfe, director of Public Citizen’s Health Research Group, in a statement released on Tuesday. “The evidence shows the drug has no unique clinical benefits but unique risks.”

Wolfe said that the FDA’s decision to keep Avandia available cannot be described as science-based or rational.

After concerns about the Avandia heart risks first surfaced in May 2007, the FDA required a “black box” warning, which is the strongest warning that can be placed on a medication label. However, many critics continued to argue that the warning was not strong enough and called for federal regulators to issue an Avandia recall because the risks greatly outweigh any benefit provided by the medication.

In July 2010, an FDA advisory panel was convened to review the risks associated with Avandia. Although the panel indicated that Avandia increases the risk of heart attacks when compared to older drugs, a majority of the committee voted to recommend that the FDA allow GlaxoSmithKline’s diabetes drug to remain on the market.

As a result of GlaxoSmithKline’s failure to adequately research the side effects of their medication or warn about the potential heart risks, the drug maker has faced tens of thousands of Avandia lawsuits filed on behalf of individuals who have suffered serious and sometimes fatal injuries. Avandia settlement agreements have been reached in many of the cases, but approximately 20,000 injury lawsuits are still pending in courts throughout the United States.