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Consumer watchdog group sues FDA over antidepressant drug

Says FDA's failure to act on Serzone is illegal

(3/17/2004) -- Public Citizen, a Washington, D.C.-based national consumer group, has sued the U.S. Food and Drug Administration (FDA) over its failure to act on a petition Public Citizen filed more than a year ago seeking a ban of the antidepressant drug nefazodone. According to a press release issued by Public Citizen, the drug is marketed by Bristol-Myers Squibb as Serzone and has been linked to a mounting number of deaths and serious injuries from liver failure.

Public Citizen's suit, filed March 15 in the U.S. District Court for the District of Columbia, asks the court to find the FDA's delay illegal and to require the agency to act, according to Public Citizen. Serzone's liver toxicity is a danger to public health, and the FDA's slow decision process continues to put patients at risk of death or serious injury, the lawsuit says.

"It is grossly negligent for the FDA to allow doctors to continue to prescribe and patients to continue to take Serzone," said Sidney Wolfe, M.D., director of Public Citizen's Health Research Group. "It's a shame that we must sue to force the agency to fulfill its obligation to protect public health."

Public Citizen's March 2003 and October 2003 petitions are on the Web at


A copy of the lawsuit is available on the Web at http://www.citizen.org/documents/Complaint_final.pdf

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