Hospital Practitioner - pharmacologist CHU de Toulouse, INSERM 1295 Toulouse, France
Background: Vaginal candidiasis is the most common gynecological infection during pregnancy. Paradoxically little is known about the risks of topical antifungal treatment on the course of pregnancy or on the fetus. Econazole, sertaconazole and fenticonazole are the most topical antifungal prescribed for pregnant women in France.
Objectives: The aim of this study was to assess the potential risks of these topical azole treatments for the pregnant woman and her fetus.
Methods: The EFEMERIS database was used; it provides data on pregnancy outcomes and medications prescribed and dispensed to pregnant women in the Haute-Garonne region who delivered between July 2004 and December 2018. We compared pregnant women exposed at least once during pregnancy to one of the three most prescribed topical azoles with unexposed women in multivariate analyses (logistic and Cox regression models).
Results: The study included 24,308 econazole-exposed pregnancies (20.9%), 16,222 sertaconazole-exposed pregnancies (15.0%), 7,209 fenticonazole-exposed pregnancies (7.3%) and 91,976 unexposed. Between 2010 and 2014 exposure to sertaconazole during pregnancy increased and, in parallel, exposure to econazole decreased. Exposure to these topical azoles during pregnancy was not associated with an increased risk of any of the outcomes studied, including pregnancy termination (miscarriages and stillbirths) (HRa econazole=0.97[0.85-1.11], HRa sertaconazole=0.92[0.78-1.08], HRa fenticonazole=1.13[0.92-1.39]) and preterm birth (HRa econazole=1.08[0.99-1.18], HRa sertaconazole=1.06[0.95-1.17], HRa fenticonazole=0.88[0.75-1.03]). No association between risk of major congenital anomalies and maternal exposure to these topical azoles during the first trimester has been observed (ORa econazole=0.97[0.83-1.14], ORa sertaconazole=1.01[0.84-1.21], ORa fenticonazole=0.91[0.68-1.21]).
Conclusions: This is the first study involving a large number of pregnant women to assess the potential risks of the most prescribed topical azoles during pregnancy. Given their pharmacokinetic properties, risks for the pregnancy and fetus were not expected. This study confirms this by showing no increased risk of pregnancy termination, prematurity and major congenital anomalies in women exposed to topical azoles.
