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Nefazodone

Hepatotoxicity; Suicidlity and Antidepressant

Hepatic Failure

  • Hepatic Failure: life-threatening cases have been reported with use.
  • The reported rate in the U.S. is approximately 1 case of liver failure resulting in death or transplant per 250,000 to 300,000 patient-years of nefazodone treatment. The total patient-years is a summation of each patient's duration of exposure expressed in years.
  • Ordinarily, treatment with nefazodone should not be initiated in individuals with active liver disease or elevated baseline serum transaminanses. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.
  • Patients should be advised to be alert for signs and symptoms of liver dysfunction, report immediately to doctor.
  • Nefazodone should be discontinued if clinical signs or symptoms suggest liver failure.

Antidepressants and Suicidality

  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in short term studies in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders.
  • Anyone considering the use of this drug or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.
  • Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.
  • Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.
  • Patients of all ages who are started on therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.
  • Families and care givers should be advised of the need for close observation and communication with the prescriber.
  • This drug is not approved for use in pediatric patients.
  • See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Do not initiate therapy in patients with active liver disease or elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases risk of liver failure, but it can complicate patient monitoring.
  • Withdraw therapy if serum AST or serum ALT > 3 times upper limit of normal. Should not be considered for re-treatment.
  • Close observation for suicidal thinking or unusual changes in behavior.

FDA and Industry Communications

Package Inserts

Nefazodone

Additional Information

Updated January 2018