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U.S. Department of Health and Human Services

Safety

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Serzone (nefazodone HCL)

Audience: Psychiatrists, Pharmacists

FDA and BMS added a Black Box Warning and strengthened the WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS sections of the label for Serzone, an antidepressant drug. Rare cases of liver failure leading to transplant and/or death in patients have been reported. A new Patient Package Insert is provided in the product packaging.

[Jan 09, 2002 - Letter - Bristol-Myers Squibb]