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Antibacterial Medication Use During Pregnancy and Risk of Birth Defects National Birth Defects Prevention Study

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Antibacterial Medication Use During Pregnancy and Risk of Birth Defects National Birth Defects Prevention Study ARTICLE Antibacterial Medication Use During Pregnancy and Risk of Birth Defects National Birth Defects Prevention Study Krista S. Crider, PhD; Mario A. Cleves, PhD; Jennita Reefhuis, PhD; Robert J. Berry, MD; Charlotte A. Hobbs, MD; Dale J. Hu, MD Objective: To estimate the association between anti- poplastic left heart syndrome (AOR=3.2; 95% CI, 1.3- bacterial medications and selected birth defects. 7.6), coarctation of the aorta (AOR=2.7; 95% CI, 1.3- 5.6), choanal atresia (AOR=8.0; 95% CI, 2.7-23.5), Design, Setting, and Participants: Population- transverse limb deficiency (AOR=2.5; 95% CI, 1.0-5.9), based, multisite, case-control study of women who had and diaphragmatic hernia (AOR=2.4; 95% CI, 1.1-5.4). pregnancies affected by 1 of more than 30 eligible major Nitrofurantoins were associated with anophthalmia or mi- birth defects identified via birth defect surveillance pro- crophthalmos (AOR=3.7; 95% CI, 1.1-12.2), hypoplas- grams in 10 states (n=13 155) and control women ran- tic left heart syndrome (AOR=4.2; 95% CI, 1.9-9.1), atrial domly selected from the same geographical regions septal defects (AOR=1.9; 95% CI, 1.1-3.4), and cleft lip (n=4941). with cleft palate (AOR=2.1; 95% CI, 1.2-3.9). Other an- tibacterial agents that showed associations included eryth- Main Exposure: Reported maternal use of antibacte- rials (1 month before pregnancy through the end of the romycins (2 defects), penicillins (1 defect), cephalospor- first trimester). ins (1 defect), and quinolones (1 defect). Main Outcome Measure: Odds ratios (ORs) measur- Conclusions: Reassuringly, penicillins, erythromy- ing the association between antibacterial use and se- cins, and cephalosporins, although used commonly by lected birth defects adjusted for potential confounders. pregnant women, were not associated with many birth defects. Sulfonamides and nitrofurantoins were associ- Results: The reported use of antibacterials increased dur- ated with several birth defects, indicating a need for ad- ing pregnancy, peaking during the third month. Sulfon- ditional scrutiny. amides were associated with anencephaly (adjusted OR [AOR]=3.4; 95% confidence interval [CI], 1.3-8.8), hy- Arch Pediatr Adolesc Med. 2009;163(11):978-985 NTIMICROBIALS, AND ANTI- tance worldwide, health care providers bacterial drugs in particu- have been forced to use a wider array of lar, are among the most newer antibiotics with no existing infor- commonly used medica- mation on safety during pregnancy. In ad- tions during pregnancy be- dition, emerging infections and prophy- cause treatment of infections is critical to lactic use during potential bioterrorism A 1,2 the health of a mother and her fetus. Al- threats may expose even more women to though it appears that some classes of an- unevaluated antibacterial and other anti- tibiotics have been used relatively safely microbial drugs during pregnancy. during pregnancy, to our knowledge there The objective of this study is to evalu- Author Affiliations: Division of have been no large-scale studies address- ate the association between selected birth Birth Defects and ing safety or risk for many classes of an- defects and antibacterial drug use during Developmental Disabilities, tibacterial drugs.1,3 Obvious ethical and lo- the critical developmental stages in early National Center on Birth gistical difficulties in studying drug safety pregnancy (1 month before pregnancy Defects and Developmental among pregnant women have limited the through the third month of pregnancy). Disabilities, Centers for Disease amount of information available to women Control and Prevention, and their health care providers in choos- METHODS Atlanta, Georgia (Drs Crider, ing a drug for needed treatment. Some an- Reefhuis, Berry, and Hu); and Department of Pediatrics, tibiotics, such as penicillins and erythro- STUDY POPULATION College of Medicine, University mycins, have had a long history of use of Arkansas for Medical without reports of deleterious effects in fe- The National Birth Defects Prevention Study Sciences, Little Rock tuses. However, due to the continually ex- is an ongoing population-based, case-control (Drs Cleves and Hobbs). panding problem of antibacterial resis- study of birth defects in the United States.4 Case (REPRINTED) ARCH PEDIATR ADOLESC MED/ VOL 163 (NO. 11), NOV 2009 WWW.ARCHPEDIATRICS.COM 978 ©2009 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/23/2021 infants with at least 1 of more than 30 categories of major birth To assess the association between antimicrobial drugs and birth defects were identified via birth defects surveillance systems defects, we defined a mother as exposed if she used an antibac- in Arkansas, California, Georgia, Iowa, Massachusetts, New Jer- terial during the periconceptional period from the month prior sey, New York, North Carolina, Texas, and Utah. Case infor- to the estimated date of conception through the end of the first mation was reviewed by clinical geneticists at each site to de- trimester (defined as the end of the third month of pregnancy). termine study eligibility. Infants with recognized or strongly Mothers who reported that they did not know whether they were suspected chromosomal abnormalities or single-gene condi- exposed or said they were exposed but were uncertain of the tim- tions were excluded from the study. After inclusion in the study, ing were excluded from regression analysis. This was a limited all cases with 1 specific defect were then classified by clinical number of participants, eg, for the analysis of any antibacterial geneticists to establish consistency for the defect and to deter- exposure, 245 case mothers (1.9%) and 75 control mothers (1.5%) mine whether the defect pattern was isolated or multiple (Ͼ1 were excluded from regression for these reasons. Mothers were major malformation). Case infants could be live born (all sites), considered unexposed if they reported no antibacterial use (any still born (all sites except New Jersey), or induced abortions class) in the periconceptional period. (all sites except Massachusetts and New Jersey). Case infants included infants with isolated and multiple defects; infants with STATISTICAL ANALYSIS multiple eligible defects were included in each of those catego- ries. Our analyses include roll-up categories, eg, we assessed Odds ratios (ORs) adjusted for potential confounders were es- associations for all included heart defects, conotruncal heart timated using logistic regression models if there were at least defects, and tetralogy of Fallot. 4 exposed cases. After review of the literature, we selected an a Control infants were a random sample of live births with- priori list of confounders that included maternal age (aged Ͻ35 out major birth defects, selected from the same geographical vs Ն35 years), race (white vs other), education (Յ12 vs Ͼ12 areas from either birth certificates or birth hospitals. Case and years), prepregnancy body mass index (calculated as weight in control infants whose estimated dates of delivery were from Oc- kilograms divided by height in meters squared) (Ͻ30 vs Ն30), tober 1, 1997, through December 31, 2003, were included in time from the estimated date of delivery to the interview (Յ12 these analyses. Mothers with incomplete interviews as well as vs Ͼ12 months), use of folic acid or multivitamins containing mothers who reported preexisting type 1 or type 2 diabetes melli- folic acid from 1 month before pregnancy through the first month tus were excluded from the analysis. The study has been ap- of pregnancy, and any periconceptional smoking or alcohol use. proved by the institutional review boards of all participating We created separate logistic regression models with the same institutions. set of confounders for each combination of birth defect and an- tibacterial medication. We performed subgroup analyses in- cluding only those cases and controls without a family history MATERNAL INTERVIEW AND of the birth defect studied. EXPOSURE HISTORY As described previously,4 mothers of case and control infants com- RESULTS pleted a detailed telephone interview in English or Spanish lan- guage within 24 months after the estimated date of delivery. Oral The participation rate in the maternal interview was 70.5% informed consent was obtained. The interview addressed pre- among case mothers and 67.2% among control moth- conceptional, periconceptional, and pregnancy exposures. It in- ers, resulting in 13 586 case mothers and 5008 control cluded questions about maternal diseases, pregnancy history, de- mothers participating. Mothers with incomplete inter- mographics, education, and medication use. Mothers could report medication use either in response to questions related to specific views (122 case mothers and 41 control mothers) as well diseases (such as respiratory illness and kidney, bladder, or uri- as mothers who reported preexisting type 1 or type 2 dia- nary tract infections) or in response to general questions about betes mellitus (310 case mothers and 26 control moth- medication use. Specific names of antibacterials were read to help ers) were then excluded from the analysis, resulting in a the mothers recall (eg, amoxicillin, Augmentin [amoxicillin and total of 13 155 case mothers and 4941 control mothers clavulanate potassium combination], Bactrim [trimethoprim and included in the analysis. sulfamethoxazole combination], and Keflex [cephalexin]). When Use of antibacterials was common among our con- a mother reported use of a medication, she was asked for details trol mothers, ranging from a prevalence of 2.0% in the about timing and duration but not for dosage information. Moth- month that was 3 months prior to conception to 5.8% ers’ responses were combined into exposures for each of the preg- during the fourth month after conception (Figure). The nancy months such that a mother could have an exposure to a specific antibacterial in the month before pregnancy and an an- most common single category of antibacterial exposure tibacterial not otherwise specified in the second month of was penicillins (Table 1). No control mothers re- pregnancy.
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