Fluconazole use and birth defects in the National Birth Defects Prevention Study.

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Fluconazole use and birth defects in the National Birth Defects Prevention Study.

Am J Obstet Gynecol. 2015 Nov 27;

Authors: Howley MM, Carter TC, Browne ML, Romitti PA, Cunniff CM, Druschel CM, National Birth Defects Prevention Study

Abstract
BACKGROUND: Low-dose fluconazole is commonly used to treat vulvovaginal candidiasis, a condition occurring frequently during pregnancy. Conflicting information exists on the association between low-dose fluconazole use among pregnant women and risk of major birth defects.
OBJECTIVE: We used data from the National Birth Defects Prevention Study to examine this association.
STUDY DESIGN: The National Birth Defects Prevention Study is a multisite, population-based, case-control study that includes pregnancies with estimated delivery dates from 1997-2011. Information on early pregnancy fluconazole use was collected by self-report from 31,645 mothers of birth defect cases and 11,612 mothers of unaffected controls. Adjusted odds ratios and 95% confidence intervals were estimated for birth defects with 5 or more exposed cases; crude odds ratios and exact 95% confidence intervals were estimated for birth defects with 3-4 exposed cases.
RESULTS: Of the 43,257 mothers analyzed, 44 case mothers and 6 control mothers reported using fluconazole. Six exposed infants had cleft lip with cleft palate, four had an atrial septal defect, and each of the following defects had three exposed cases: hypospadias, tetralogy of Fallot, d-transposition of the great arteries, and pulmonary valve stenosis. Fluconazole use was associated with cleft lip with cleft palate (odds ratio=5.53; confidence interval=1.68-18.24) and d-transposition of the great arteries (odds ratio =7.56; confidence interval =1.22-35.45).
CONCLUSIONS: The associations between fluconazole and both cleft lip with cleft palate and d-transposition of the great arteries are consistent with earlier published case reports, but not recent epidemiologic studies. Despite the larger sample size of the National Birth Defects Prevention Study, fluconazole use was rare. Further investigation is needed in large studies, with particular emphasis on oral clefts and conotruncal heart defects.

PMID: 26640069 [PubMed - as supplied by publisher]