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Antifungal Drugs and the Risk of Selected Birth Defects.91.E1- Am J Obstet Gynecol 2008;198:1 191.E7

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Antifungal Drugs and the Risk of Selected Birth Defects.91.E1- Am J Obstet Gynecol 2008;198:1 191.E7 Research www.AJOG.org OBSTETRICS Antifungal drugs and the risk of selected birth defects Tonia C. Carter, PhD; Charlotte M. Druschel, MD, MPH; Paul A. Romitti, PhD; Erin M. Bell, PhD; Martha M. Werler, PhD; Allen A. Mitchell, MD; for the National Birth Defects Prevention Study OBJECTIVE: This study examined whether first-trimester antifungaldiovascular defects. An increased risk of 1.88 was observed for dia- drug use was associated with the risk of selected birthphragmatic defects. hernia but was not statistically significant. Estimates ap- proximated unity for neural tube defects, oral clefts, anorectal atresia, STUDY DESIGN:Subjects were participants in a case-control study, hypospadias, and craniosynostosis. the National Birth Defects Prevention Study, with singleton deliveries from 1997 to 2003. Based on maternal interviews, first-trimesterCONCLUSION: anti- First-trimester antifungal drug exposure was not fungal drug use was compared between 7047 cases withstrongly isolated associated de- with the risk of most birth defects, but further stud- fects and 4774 nonmalformed controls using unconditionalies logisticshould examine the preliminary results of an association with hy- regression. poplastic left heart syndrome. RESULTS: Risk was elevated for hypoplastic left heart syndromeKey words:(oddsantifungal agents, congenital abnormalities, pregnancy, ratio, 2.30; 95% confidence interval, 1.04, 5.06) but notteratogens for other car- Cite this article as: Carter TC, Druschel CM, Romitti PA, et al. Antifungal drugs and the risk of selected birth defects.91.e1- Am J Obstet Gynecol 2008;198:1 191.e7. he most common clinical indica-associated with hypospadias,6 and top- data from a large, population-based T tion for antifungal drug useical ineconazole exposure was associatedstudy. women is vulvovaginal candidiasis,with cardiovascular defects but not and the Centers for Disease Controlwhen exposure was restricted to Mdrug ATERIALS ANDM ETHODS and Prevention (CDC) have recom-prescriptions documented in medical 7 Data were obtained from the National mended topical azole antifungal med-records. Birth Defects Prevention Study, an on- ication (butoconazole, clotrimazole, Although previous studies have going,not multisite, case-control study of miconazole, tioconazole, terconazole)established whether antifungal drugsthe causes of birth 8defects. The study has for the treatment of this conditioncan causein birth defects, their terato- 1 been approved by the institutional re- pregnancy. In animal studies, birthgenic potential should be evaluatedview boards of the study sites and the defects have been associated withbecause ex- of their use in pregnancyCDC. toCases and controls were identified posure to the antifungal drugs 5-fluo-treat a common, and sometimes recur- 2,3 by the birth defects surveillance systems rocytosine and fluconazole.In hu- ring, vaginal infection. The aim inof 10this states (Arkansas, California, Geor- mans, case-control studies found studyno was to determine whether gia,there Iowa, Massachusetts, New Jersey, increased risk of birth defects withis antop- association between first-trimes-New York, Texas, North Carolina, ical clotrimazole or tolnaftate expo-ter exposure to antifungal drugs and 4,5 Utah). Controls were live births without sure ; however, oral nystatin usethe was risk of selected birth defectsbirth using defects that were randomly selected from birth certificates or birth hospitals From the Department of Epidemiology, School of Public Health, State Universityin the of geographicNew regions monitored by York at Albany, Albany (Drs Carter, Druschel, and Bell); the Congenital Malformations the state surveillance systems. Cases in- Registry, Center for Environmental Health, New York State Department of Health, Troy (Dr Druschel), NY; the Department of Epidemiology, University of Iowa College of cluded live births, stillbirths 20 weeks or Medicine, Iowa City, IA (Dr Romitti); and the Slone Epidemiology Center at Boston longer or greater than 500 g, or elective University, Boston, MA (Drs Werler and Mitchell). terminations. Received Feb. 23, 2007; revised May 24, 2007; accepted Aug. 21, 2007. Reprints: Tonia Carter, Epidemiology Branch, Division of Epidemiology, Statistics, and Case classification Prevention Research, National Institute of Child Health and Human Development, 6100 Medical records, including data on phys- Executive Blvd, Room 7B03C MSC 7510, Bethesda, MD 20892-7510. [email protected] exams, clinical tests, surgeries, and This study was supported by a cooperative agreement with the Centers for Disease Control and autopsies, were obtained for all cases to Prevention, Grant U50/CCU223184. The findings and conclusions in this report are those of the confirm the presence of birth defects. authors and do not necessarily represent the views of the Centers for Disease Control and Prevention. Clinical geneticists reviewed this infor- 0002-9378/$34.00 • © 2008 Mosby, Inc. All rights reserved. • doi: 10.1016/j.ajog.2007.08.044 mation for all cases to classify them as isolated (if all birth defects were confined FEBRUARY 2008 American Journal of Obstetrics & Gynecology 191.e1 Research Obstetrics www.AJOG.org to the same organ system or body part) Exposure neural tube defects (anencephaly, or nonisolated9; those with known Maternalsin- reports of medication use were craniorachischisis, spina bifida, enceph- gle-gene disorders or chromosomal ab- matched to the active ingredient in the alocele); cleft lip with or without cleft normalities were excluded. Classifica- Boston University Slone Epidemiology palate; anorectal atresia; hypospadias tion was intended to define case groups Center Drug Dictionary (a computer- (second or third degree); craniosynosto- that were more likely to be etiologically ized database of prescription and non- sis; gastroschisis; diaphragmatic hernia; homogenous; for example, isolated prescription drugs that links drug prod- conotruncal heart defects (truncus arte- craniosynostosis cases are probably ucts to their generic ingredients) to riosus, interrupted aortic arch type B, d- etiologically distinct from cases that identify subjects who used antifungal transposition of the great arteries, dou- have other types of isolated defects or drugs in the first trimester. The date of ble outlet right ventricle, tetralogy of cases with multiple defects including conception was considered to be 266 Fallot, pulmonary valve atresia with ven- craniosynostosis. days before the EDD reported by the tricular septal defect–tetralogy of Fallot Based on clinical and pathological cri- mother or obtained from the medical anatomy, ventricular septal defect– teria, cardiovascular defects were addi- record if no date was provided by the conoventricular); left ventricular out- tionally classified as simple, associations, mother. Subjects were classified as ex- flow tract obstructive defects (aortic or complex. The defects were character- posed if they used at least 1 antifungal stenosis, coarctation of the aorta, inter- ized as simple if no other cardiovascular drug in the first trimester (the 90-day pe- rupted aortic arch type A, hypoplastic defects were present, and they were con- riod that started with the date of concep- left heart syndrome); right ventricular sidered to be either specific, single de- tion). Five subjects reported their only outflow tract obstructive defects (pul- fects (eg, atrial septal defect) or a well- fungal infection to be a vaginal yeast in- monary valve stenosis/atresia, tricuspid defined pattern of defects recognized as a fection in the first trimester and also used atresia, Ebstein anomaly); ventricular single diagnostic entity (eg, hypoplastic an antifungal drug but did not recall the septal defects (excluding conoventricu- left heart syndrome, which is composed date of use; their antifungal drug expo- lar type); and atrial septal defects–secun- of a hypoplastic left ventricle and anom- sure was assigned as first trimester. dum type or not otherwise specified. alies of the mitral valve, aortic valve, and ascending aorta). Defects were described as associations if there were 2 or 3 simple Inclusion and exclusion criteria Statistical analysis cardiovascular defects that are known to The study included 12,733 cases and Initially, potential confounders were occur frequently together (eg, atrial sep- 4856 controls that were singleton deliv- identified based on their association with tal defect–secundum type with a ventric- eries between October 1997 and Decem- the exposure or outcomes in the pub- ular septal defect–perimembranous), ber 2003. Mothers who reported a diag- lished literature. Those associated with but no other cardiovascular defects were nosis of type 1 or 2 diabetes before the exposure included urinary tract in- present. Complex defects were those that conception (278 cases, 25 controls), had fections in the first trimester (Yes/No) occurred in multiple cardiac structures. diabetes of unknown type (18 cases, 0 and use 1 month before conception Associations and complex defects are controls), and did not provide informa- through the first trimester of the follow- considered likely to have a different eti- tion on ever being diagnosed with diabe- ing: antibiotics (Yes/No), hormonal ology from simple defects. tes (23 cases, 10 controls) were excluded. contraceptives (Yes/No), and an intra- Also excluded were 93 cases and 32 con- uterine device (Yes/No). Those related trols who did not provide information to the outcomes were maternal age-years Data collection on medication use in pregnancy
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