ABSTRACT
<b>Objective</b>: Novel antipsychotic agents less frequently cause extrapyramidal side effects compared to conventional antipsychotic agents, contributing to improvement in the QOL. Recently, these agents have also been increasingly prescribed to females who may become pregnant. In Japan, no epidemiological survey regarding the application of novel antipsychotic agents in pregnant women has been published. In this study, we investigated the influence on fetuses in pregnant women receiving novel antipsychotic agents.<br><b>Methods</b>: In pregnant women on novel antipsychotic agents who consulted the Pregnancy and Drug Consultation Outpatient Clinic of Toranomon Hospital, the outcome of pregnancy was confirmed.<br><b>Results</b>: Twenty-nine pregnant women took novel antipsychotic agents in the organogenesis phase, in which the risk of teratogenicity is the highest. The agents consisted of olanzapine in 8 patients, risperidone in 11, quetiapine fumarate in 7, and perospirone hydrochloride hydrate in 4. The outcomes of pregnancy were full-term delivery in 24 patients, premature delivery in 1, spontaneous abortion in 2, and artificial abortion in 2. Of the 29 patients, 15 (60%) had continuously taken these agents until delivery. All 25 neonates were healthy without malformation.<br><b>Conclusion</b>: This report describes the first prospective survey in Japan regarding infants delivered by pregnant women receiving novel antipsychotic agents. All patients delivered healthy neonates; the incidence of congenital anomalies did not exceed that in the general population. This survey included a small number of patients; cohort studies should be conducted to evaluate the safety in fetuses.
ABSTRACT
<b>Objective</b>: Treatment of tinea unguium with topical drugs alone is difficult, and medication with oral terbinafine hydrochloride is necessary in many cases. Since Trychophyton infects the nails in not only men but also women at a reproductive age, the influence on a fetus of the drug ingested during early pregnancy is a matter of concern of many women. The objective of this study was to investigate the influence of oral terbinafine hydrochloride on fetuses.<br><b>Methods</b>: The outcomes were investigated in pregnant women who ingested terbinafine hydrochloride and visited the ‘Outpatient Services for Consultation on Pregnancy and Drugs (Teratology Information Services)’ of Toranomon Hospital, and cases were collected.<br><b>Results</b>: Fifteen pregnant women ingested the drug during the organogenic period, in which the teratogenic risk is the highest. All 15 pregnant women gave birth to healthy babies.<br><b>Conclusion</b>: This is the first survey concerning newborns delivered by women who ingested terbinafine hydrochloride during pregnancy in Japan. All investigated women gave birth to healthy babies, and the incidence of congenital abnormalities did not markedly exceed that in the general population. Since the number of cases was small, it is necessary to perform a cohort study to investigate details of the safety for fetuses.