January 15, 2002
PCN Issues Drug Safety Alert to
Physicians Warning of Cases of Hepatotoxity With the Use of Serzone
- 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should be withdrawn from the drug.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
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