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From the Food and Drug Administration
March 6, 2002

Warning on Serzone

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JAMA. 2002;287(9):1103. doi:10.1001/jama.287.9.1103

The FDA has issued a warning that cases of life-threatening hepatic failure have been reported in patients using nefazodone hydrochloride (Serzone, Bristol-Myers Squibb, Princeton, NJ), a treatment for depression. Patients taking Serzone should be advised to report signs and symptoms of liver dysfunction such as jaundice, anorexia, or gastrointestinal complaints to their physician immediately. If they develop evidence of hepatocellular injury, such as increased serum aspartate aminotrasferase or serum alanine at levels three times or higher than the upper limit of normal,they should be withdrawn from the drug and should not be considered for re-treatment.

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