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U.S. Department of Health and Human Services

Safety

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Serzone (nefazodone hydrochloride)

Audience: Neuropsychiatric healthcare professionals

FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION, and WARNINGS sections to encourage healthcare providers to engage in a thorough risk-benefit analysis, including consideration of the risk of hepatic failure associated with Serzone treatment, when deciding among alternative treatments available for depression. In addition, healthcare providers and consumers are cautioned about the need for close observation of patients being treated with antidepressants for clinical worsening of the symptoms of depression, for the emergence of suicidality, and for the emergence of a variety of other symptoms that may represent a worsening of the patient's condition.

[June 18, 2004 - Letter - Bristol-Myers Squibb]