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FDA Sued Over Antidepressant

A U.S. consumer group, Public Citizen, today sued the Food and Drug Administration in an effort to get the agency to ban a Bristol-Myers Squibb antidepressant linked to liver damage. Last year they petitioned the FDA to remove the antidepressant Serzone from the market because it has been linked to at least 11 deaths in the United States from liver toxicity. In 2001, there were more than 4.5 million prescriptions for Serzone filled in the United States. Serzone inhibits a key enzyme that is involved in the detoxification of many prescription drugs, which increases the dangers of toxicity from other drugs a patient is taking at the same time. Additionally, Serzone can become more concentrated and potentially toxic itself when this enzyme is inhibited.

Not very good news for the SSRI antidepressants, which have recently been linked with suicides in children.

Public Citizen March 15, 2004

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