Monday, March 15, 2004 1:57:08 PM
UPDATE - US group sues FDA over drug linked to liver damage
Monday March 15, 1:35 pm ET
WASHINGTON, March 15 (Reuters) - A U.S. consumer group on Monday sued the Food and Drug Administration (News - Websites) in an effort to get the agency to ban a Bristol-Myers Squibb (NYSE:BMY - News) antidepressant linked to liver damage.
The group, Public Citizen, said it filed the suit because the FDA had failed to act on a petition filed more than a year ago to outlaw the antidepressant, called Serzone.
"It is grossly negligent for the FDA to allow doctors to continue to prescribe, and patients to continue to take, Serzone," Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, said in a statement.
The group cited reports of 55 cases of liver failure among Serzone users, including 20 deaths.
A Bristol-Myers spokesman could not immediately be reached for comment. In the past the company has defended Serzone as an important option for treating depression and said liver problems were rare.
FDA spokeswoman Susan Cruzan said the agency would review the lawsuit.
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