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Information on the Drug Serzone: Public Citizen Asks FDA to Ban Serzone

March 7, 2003

Consumer interest group Public Citizen called on the U.S. Food and Drug Administration (FDA) Thursday to immediately ban the antidepressant medication Serzone, citing its link to life-threatening liver toxicity that has led to at least 11 deaths in the United States. In January, Serzone maker Bristol-Myers Squibb stopped selling the drug in Europe, where it was marketed under the brand name Dutonin, after a number of users, including 18 who died, developed liver complications such as jaundice, hepatitis, and liver failure.

Public Citizen argued that the FDA already requires that Serzone carry a black box warning, the strongest notice a medication can carry, alerting potential users to the drug's association with cases of life-threatening hepatic failure.

-- Article Courtesy of InjuryBoard.com

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