Consumer Group Files Lawsuit Against FDA Over Serzone
Monday, March 15th, 2004Source: Public Citizen
A consumer advocacy group on Monday filed a lawsuit against the U.S. Food and Drug Administration over the anti-depressant drug Serzone, which has been linked to a number of deaths and serious injuries from liver failure.
The group, Public Citizen, said it filed the lawsuit because the FDA had failed to act on a petition filed more than a year ago seeking a ban on Serzone.
“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.”
Serzone, which is marketed by Bristol-Myers Squibb, has been removed from the market in Canada and Europe and is scheduled to be withdrawn in Australia and New Zealand in May, Public Citizen said.
In March 2003, Public Citizen sought a ban on Serzone, citing 21 cases of liver failure and 11 deaths between 1994 and 2002. A supplemental petition, submitted to the FDA in October 2003, included an analysis of the FDA Adverse Event Reports Database. That analysis showed that, from April 1, 2002, through May 12, 2003, there were 33 additional reports of liver failure - including nine deaths - for a total of 55 patients with liver failure, including 20 deaths, according to Public Citizen.
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