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Warning on Serzone
JAMA. 2002;287:1103.
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| Since this article does not have an abstract, we have provided the first 108 words of the full text and any section headings. |
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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aminotrasferase or serum alanine at levels three times or higher than the upper limit of normal,they should be withdrawn from the drug and should not be considered for re-treatment.
AUTHOR INFORMATION
Written inquiries may be directed to Office of the Commissioner of Food and Drugs, HF-1, Room 14-71, 5600 Fishers Ln, Rockville, MD 20857.
Bernard A. Schwetz, DVM, PhD
Acting Principal Deputy Commissioner Food and Drug Administration
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