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January 15,  2002

PCN Issues Drug Safety Alert to Physicians Warning of Cases of Hepatotoxity With the Use of Serzone


 (SafetyAlerts) - Pharmaceutical Care Network (PCN), a leading pharmacy benefit manager (PBM), is alerting physicians of the new black box warning for Serzone (nefazodone), a medication commonly used for the treatment of depression.

Cases of life-threatening hepatic failure resulting in transplantations or deaths have been reported in patients treated with Serzone at a reported rate of 1 case per 250,000 to 300,000 patient-years of Serzone treatment. The Federal Food and Drug Administration (FDA) has advised that treatment with Serzone should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. Patients who develop evidence of hepatocellular injury, such as increased serum AST or serum ALT levels 3 times or greater than the upper limit of normal while on Serzone should be withdrawn from the drug.

Upon receiving notification of Serzone's new black box warning, PCN immediately incorporated the information into its December issue of the Drug Therapy Council Newsletter focusing on the pharmacologic treatment of depression. The DTC Newsletter is distributed to health care professionals, including physicians and pharmacists, and is accessible at the PCN website on

Additionally, PCN used its new, web-enabled version of MedIntelligence(R) Analytical Guide Pro(TM), a proprietary PCN data warehouse query software to comprehensively identify all patients in PCN administered programs currently receiving Serzone. To ensure patient safety, PCN alerted those patients' physicians of Serzone's potential hepatotoxicity through notifications/alerts using PCN's MedIntelligence(R) Case Management Support(TM).

Source: PRNewswire.

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