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.