Population-based case-control teratologic study of topical miconazole.
Miconazole cream is used in Hungary to treat fungal genital and skin infections in pregnant women, but it causes anxiety for both patients and medical doctors due to the category C classification of the drug regarding teratogenic or fetotoxic risk. The objective of this case-control study was to analyze the teratogenic potential of topical miconazole used during pregnancy in the mothers of babies with congenital abnormalities and in matched control mothers of babies without congenital abnormalities. The population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996 included 22 843 women who had newborns or fetuses with congenital abnormalities, and 38 151 pregnant women who had newborn infants without any defects (controls). In the case group, 24 (0.11%) and in the control group, 46 (0.12%) pregnant women were treated with miconazole (crude odd ratio [OR]: 0.9 with 95% confidence interval [CI]: 0.6-1.6). Different congenital abnormality groups were evaluated in case-control pairs and a higher prevalence of miconazole treatment was not found during the second or third month of pregnancy. Thus, treatment with topical miconazole during pregnancy does not increase the risk of congenital abnormalities.
Foundation for the Community Control of Hereditary Diseases, Budapest, Hungary. czeizel@interware.hu
Andrew Endre
AE
Czeizel
Zoltán
Z
Kazy
Erzsébet
E
Puhó
D000014:Abnormalities, Drug-Induced / Q000503:physiopathology*; D000287:Administration, Topical; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D008825:Miconazole / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D011247:Pregnancy
D000935:Antifungal Agents; D008825:Miconazole