Legal News Watch - Consumer Rights Blog

Consumer Group Asks FDA to Withdraw Serzone

March 10th, 2003 · No Comments

Consumer advocacy group Public Citizen submitted a petition to the US Food and Drug Administration urging the agency to remove from the market the popular antidepressant Serzone (nefazodone), manufactured by Bristol-Myers Squibb.

Public Citizen argues that based on adverse reaction reports to the FDA, Serzone, was associated with at least 53 cases of liver injury including 21 cases of liver failure from which 11 people died.

“There is no good reason to keep this drug on the market. It is no more effective than other antidepressants, and it presents a unique health hazard for patients,” said Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group.

Public Citizen said worldwide, Bristol-Myers Squibb itself acknowledges 28 reports of liver failure, including 18 deaths.

(via Public Citizen)

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Tags: Serzone

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