Abstract

Purpose - This study was a pharmacovigilance exercise which aimed to determine the post-marketing event profile of nefazodone, a newly marketed antidepressant, in community use.

Methods - Information was collected on patients included in a non-interventional observational cohort study conducted by means of Prescription-Event Monitoring in England.  Incidence densities were calculated for all reported events.

Results - Information was obtained for 11,834 patients.  Nausea and dizziness were the most frequent adverse events that led to stopping nefazodone and the most frequently reported events during the first month of treatment.  Unsteadiness and falls were reported more frequently in the elderly.  Hepatic events, involuntary movements, thrombocytopenia, hallucinations and withdrawal reactions were reported rarely but were possibly associated with nefazodone.  Eight overdoses involving nefazodone alone were reported with no serious clinical sequelae.  Two premature births, one low birth weight term baby and two babies with renal abnormalities were outcomes in 38 pregnancies exposed in the first trimester to nefazodone.  One death in a woman aged 71 years followed an illness with serotonergic features.

Conclusions - Event data are presented for patients dispensed nefazodone in the community.  The findings are discussed.