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

Meredith M Howley; Tonia C Carter; Marilyn L Browne; Paul A Romitti; Christopher M Cunniff; Charlotte M Druschel; National Birth Defects Prevention Study

doi:10.1016/j.ajog.2015.11.022

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

Journal article

Peer reviewed

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

Meredith M Howley, Tonia C Carter, Marilyn L Browne, Paul A Romitti, Christopher M Cunniff, Charlotte M Druschel and National Birth Defects Prevention Study

American journal of obstetrics and gynecology, Vol.214(5), pp.657.e1-657.e9

05/2016

DOI: 10.1016/j.ajog.2015.11.022

PMID: 26640069

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https://pmc.ncbi.nlm.nih.gov/articles/PMC10041360/pdf/nihms-1880675.pdfView

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Abstract

Low-dose fluconazole is used commonly 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 the risk of major birth defects. We used data from the National Birth Defects Prevention Study to examine this association. The National Birth Defects Prevention Study is a multisite, population-based, case-control study that includes pregnancies with estimated delivery dates from 1997 to 2011. Information on fluconazole use in early pregnancy 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. 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, 4 had an atrial septal defect, and each of the following defects had 3 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). 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.

birth defect

fluconazole

congenital malformation

Details

Title: Subtitle: Fluconazole use and birth defects in the National Birth Defects Prevention Study
Creators: Meredith M Howley - Congenital Malformations Registry, New York State Department of Health, Albany, NY
Tonia C Carter - Center for Human Genetics, Marshfield Clinic, Marshfield, WI
Marilyn L Browne - Congenital Malformations Registry, New York State Department of Health, Albany, NY
Paul A Romitti - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA
Christopher M Cunniff - Department of Pediatrics, Weill Cornell Medical College, New York, NY
Charlotte M Druschel - Congenital Malformations Registry, New York State Department of Health, Albany, NY
National Birth Defects Prevention Study
Resource Type: Journal article
Publication Details: American journal of obstetrics and gynecology, Vol.214(5), pp.657.e1-657.e9
DOI: 10.1016/j.ajog.2015.11.022
PMID: 26640069
NLM abbreviation: Am J Obstet Gynecol
ISSN: 0002-9378
eISSN: 1097-6868
Publisher: Elsevier Inc
Grant note: U01/DD00048702 / Centers for Disease Control and Prevention
Language: English
Date published: 05/2016
Academic Unit: Epidemiology; Biostatistics
Record Identifier: 9983995133502771

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