The prominent consumer advocacy group Public Citizen is criticizing the FDA for not forcing an Avandia recall, indicating that the federal regulatory agency is endangering public health by allowing the diabetes drug to remain on the market despite the known increased risk of heart attacks and death from side effects of Avandia.
In a statement released last week, the non-profit organization took the FDA to task over its decision last week to restrict the use of Avandia instead of recalling it.
“By failing to ban the dangerous diabetes drug, Avandia, generic name rosiglitazone, the Food and Drug Administration (FDA) again caved to industry pressure,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “Although the FDA has made progress highlighting the risks of using Avandia by severely restricting the drug, it did not go far enough. Too many people could still be exposed to this dangerous product.”
The FDA has determined that only patients who have failed to control their diabetes through every other available medication should be given access to GlaxoSmithKline’s Avandia, and has ordered the company to develop a risk evaluation and mitigation strategy (REMS) to make sure the drug is adequately restricted. The decision came after an FDA advisory committee voted this summer to recommend that the drug stay on the market, but with warnings and restrictions.
In Europe, drug regulators have decided to ban Avandia, announcing their decision on the same day the FDA decided only to restrict use in the United States.
Avandia (rosiglitazone) was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted following the concerns about potential Avandia heart risks.
“More than three years ago at an FDA advisory committee meeting, Public Citizen urged the FDA to ban Avandia. Since then, 9 million prescriptions for the drug have been filled in the United States,” Wolfe wrote. “This means that, just in the past three years alone, tens of thousands more patients have needlessly suffered hospitalizations for heart failure or deaths than would have had they taken Actos, a comparable, but safer drug.”
GlaxoSmithKline faced about 13,000 Avandia lawsuits filed by plaintiffs who accuse the company of failing to warn patients that of Avandia heart attack risks. Earlier this summer the company announced it had reached Avandia settlements in about 10,000 of those suits.