A population-based case-control teratological study of vaginal econazole treatment during pregnancy.
OBJECTIVE
To study human risk and benefit of vaginal econazole treatment during pregnancy.


METHODS
Pair analysis of cases with congenital abnormalities and matched controls in the population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA), 1980-1996.


RESULTS
Of 38151 pregnant women who had newborn infants without any congenital abnormalities (control group), 122 (0.3%), of 22843 case pregnant women who had newborns or fetuses with congenital abnormalities, 68 (0.3%) used vaginal suppository of econazole (crude prevalence odds ratio (POR): 0.9, with 95% confidence interval (CI): 0.7-1.3). The matched case-control pair analysis did not indicate any teratogenic potential of econazole use during the second and third months of gestation, i.e. in the critical period for most major congenital abnormalities.


CONCLUSIONS
Treatment with econazole during pregnancy does not indicate any teratogenic risk to the fetus.
Czeizel
Andrew E
AE
Foundation for the Community Control of Hereditary Diseases, Budapest, Hungary. czeizel@interware.hu
Kazy
Zoltán
Z
Vargha
Peter
P
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000282:Administration, Intravaginal; D000935:Antifungal Agents / Q000009:adverse effects*; D001724:Birth Weight; D016022:Case-Control Studies; D004464:Econazole / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D005865:Gestational Age; D006801:Humans; D006814:Hungary / Q000453:epidemiology; D016017:Odds Ratio; D011247:Pregnancy; D012042:Registries; D012307:Risk Factors
D000935:Antifungal Agents; D004464:Econazole