Pregnancy outcome following first trimester exposure to Terbinafine Hydrochloride : A case series survey / 医薬品情報学

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.