The guideline recommends the serotonin modulator nefazodone as an effective medication for the treatment of depression. However, before initiating or continuing treatment with nefazodone, consideration should be given to the recent reports of life-threatening hepatic failure in patients treated with nefazodone (2–8). These reports have led the Food and Drug Administration (FDA) to change the drug's labeling, adding a black box warning of possible liver failure leading to death and/or a need for transplant and contraindicating the drug in patients who were withdrawn from it because of evidence of liver injury. According to the warning, the reported rate of liver failure resulting in death or transplant in the United States is about 1 case per 250,000–300,000 patient-years of nefazodone treatment. This represents a rate of about three to four times the estimated background rate of liver failure and is probably an underestimate. There are no known predictors of the development of liver toxicity and failure with nefazodone; toxicity and failure have been reported in individuals early in the course of treatment as well as in persons receiving stable dosages for many months. The FDA warns that patients with preexisting liver disease should not be treated with nefazodone and that patients should be advised to immediately report symptoms that may indicate liver dysfunction, such as jaundice, anorexia, gastrointestinal complaints, and malaise. The warning is available at http://www.fda.gov/medwatch/SAFETY/2002/serzone_deardoc.pdf.


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