Nefazodone in community use: The results of prescription-event monitoring

Purpose - This study was a pharmacovigilance exercise which aimed to determ ine the postmarketing event profile of nefazodone, a newly marketed antidep ressant, in community use. Methods - Information was collected on patients included in a non-intervent ional observational cohort study conducted by means of Prescription-Event M onitoring in England. Incidence densities were calculated for all reported events. Results - Information was obtained for 11834 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. Un steadiness and falls were reported more frequently in the elderly. Hepatic events, involuntary movements, thrombocytopenia, hallucinations and withdra wal reactions were reported rarely but were possibly associated with nefdzo done. Eight overdoses involving nefazodone alone were reported with no seri ous clinical sequelae. Two premature births, one low birth weight term baby and two babies with renal abnormalities were outcomes in 38 pregnancies ex posed in the first trimester to nefazodone. One death in a woman aged 71 ye ars followed an illness with serotonergic features. Conclusions - Event data are presented for patients dispensed nefazodone in the community. The findings are discussed. Copyright (C) 1999 John Wiley & Sons, Ltd.