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Maternal Butalbital Use and Selected Defects in the National Birth Defects Prevention Study

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Maternal Butalbital Use and Selected Defects in the National Birth Defects Prevention Study Headache ISSN 0017-8748 © Published 2013. doi: 10.1111/head.12203 This article is a U.S. Government work and is in the public domain in the USA Published by Wiley Periodicals, Inc. Research Submission Maternal Butalbital Use and Selected Defects in the National Birth Defects Prevention Study Marilyn L. Browne, PhD; Alissa R. Van Zutphen, PhD; Lorenzo D. Botto, MD; Carol Louik, ScD; Sandra Richardson, MS; Charlotte M. Druschel, MD Background.—Butalbital is a barbiturate contained in combination products with caffeine and an analgesic prescribed for the treatment of migraine and tension-type headaches. Controversy exists as to whether butalbital should continue to be prescribed in the United States because of the potential for abuse, overuse headache, and withdrawal syndromes. Butalbital crosses the placenta but there is limited information about potential teratogenicity. Objective.—To evaluate associations between butalbital and a wide range of specific birth defects. Methods.—The National Birth Defects Prevention Study is an ongoing, case–control study of nonsyndromic, major birth defects conducted in 10 states. The detailed case classification and large number of cases in the National Birth Defects Prevention Study allowed us to examine the association between maternal self-reported butalbital use and specific birth defects. We conducted an analysis of 8373 unaffected controls and 21,090 case infants with estimated dates of delivery between 1997 and 2007; included were birth defects with 250 or more cases. An exploratory analysis examined groups with 100 to 249 cases. Results.—Seventy-three case mothers and 15 control mothers reported periconceptional butalbital use. Of 30 specific defect groups evaluated, adjusted odds ratios for maternal periconceptional butalbital use were statistically significant for 3 congenital heart defects: tetralogy of Fallot (adjusted odds ratio = 3.04; 95% confidence interval = 1.07−8.62), pulmonary valve stenosis (adjusted odds ratio = 5.73; 95% confidence interval = 2.25−14.62), and secundum-type atrial septal defect (adjusted odds ratio = 3.06; 95% confidence interval = 1.07−8.79). In the exploratory analysis, an elevated odds ratio was detected for 1 congenital heart defect, single ventricle. Conclusions.—We observed relationships between maternal periconceptional butalbital use and certain congenital heart defects. These associations have not been reported before, and some may be spurious. Butalbital use was rare and despite the large size of the National Birth Defects Prevention Study, the number of exposed case and control infants was small. However, if confirmed in additional studies, our findings will be useful in weighing the risks and benefits of butalbital for the treatment of migraine and tension-type headaches. Key words: butalbital, headache, migraine, birth defect (Headache 2013;••:••-••) From the Congenital Malformations Registry, New York State Department of Health, Albany, NY, USA (M.L. Browne, A.R. Van Zutphen, S. Richardson, and C.M. Druschel); School of Public Health, University at Albany, Rensselaer, NY, USA (M.L. Browne, A.R. Van Zutphen, and C.M. Druschel); Division of Medical Genetics, Dept. of Pediatrics, University of Utah, Salt Lake City, UT, USA (L.D. Botto); Slone Epidemiology Center, Boston University, Boston, MA, USA (C. Louik). Address all correspondence to M.L. Browne, Congenital Malformations Registry, New York State Department of Health, Empire State Plaza-Corning Tower, Room 1203, Albany, NY 12237, USA, email: [email protected] Accepted for publication July 18, 2013. Conflict of Interest: The authors report no conflict of interest. 1 2 BACKGROUND a wide range of specific birth defects using NBDPS Butalbital is a short- to intermediate-acting bar- data. biturate that can produce central nervous system depression ranging from mild sedation to general METHODS anesthesia.1 Combination products containing The NBDPS is a multisite population-based butalbital with caffeine and an analgesic, acetamino- case–control study that began in 1997.8 Infants with 1 phen, aspirin, or codeine are prescribed for the treat- or more of over 30 different categories of major struc- ment of migraine and tension-type headaches. In a tural defects (cases), excluding those attributed to a study of patterns of prescription medication use in the known chromosomal abnormality or single-gene con- management of headache in the United States, 17% dition, were ascertained through birth defects surveil- of survey respondents reported use of a butalbital- lance systems in 10 states (AR, CA, GA, IA, MA, NC, containing product.2 Nevertheless, recently published NJ, NY, UT, and TX). Each study site obtained insti- guidelines do not recommend butalbital-containing tutional review board approval for the NBDPS; products for treatment of migraine headache,3 and informed consent was provided by all participants. some European countries have banned its use The authors had full access to all the data in the study. because of the well-known potential for abuse, Population-based data were collected from either the overuse headache, and withdrawal syndromes.1 entire state or selected regions of the state. Control Butalbital, similar to other barbiturates, sup- infants were liveborn infants without birth defects presses neuronal responses by enhancing γ- randomly selected from hospital records (AR, CA, aminobutyric acid (GABA) binding to GABAA NY, TX), birth certificates (IA, MA, NC, NJ, UT), or receptors.1 Studies of other barbiturates, in particular both (GA: hospital record, 1997-2000; birth certifi- the antiseizure medication, phenobarbital, indicate cate, 2001-1007) in the same time period and geo- a teratogenic effect.4,5 A suggested mechanism is graphic areas as the cases. through bradyarrhythmias, hemodynamic changes, Included in the present study were births with an and hypoxia caused by blockage of ion channels in the estimated date of delivery (EDD) from October 1997 embryonic heart.4 In an analysis of drug registry data through December 2007. Control infants and infants based on relatively small numbers of exposed cases,an with birth defects for which 100 or more cases were excess of heart defects was observed (4/51 infants available for study were included. The main analysis exposed to the higher dose of phenobarbital).5 Risks comprised birth defects with greater study power (250 to the fetus from maternal butalbital use have been infants or more).To avoid missing strong effects in small little studied and have not been taken into account in case groups,we also conducted an exploratory analysis of the controversy as to whether butalbital should con- birth defects with 100-249 infants. We excluded infants tinue to be prescribed in the United States.Two previ- with a maternal history of type 1 or type 2 diabetes ous studies of maternal butalbital use did not find diagnosed before pregnancy because pre-existing diabe- significant associations with birth defects.6,7 tes is associated with increased risk of a variety of birth Investigators with the National Birth Defects defects.9,10 Participation rates were 69% and 66% for Prevention Study (NBDPS), a large ongoing case– eligible case and control mothers, respectively. control study of risk factors for birth defects, periodi- Case inclusion criteria have been described by cally conduct screens of the study database to detect Yoon et al.8 Clinical geneticists reviewed and classi- signals for increased risks between medication com- fied each case infant as having isolated or multiple ponents and specific birth defects. In 1 such screen, an birth defects (2 or more major unrelated defects).11 To association was observed between periconceptional reduce etiologic heterogeneity within case groups, (defined as 1 month preconception through the third we excluded infants classified as having a complex month of pregnancy) butalbital use and pulmonary sequence (a group of defects that are believed to be valve stenosis. This finding prompted us to conduct a pathogenetically related, but for which the primary formal analysis of self-reported butalbital use and defect is not apparent). Headache 3 Only structural heart defects confirmed by phone interview to collect information about demo- echocardiography, cardiac catheterization, or autopsy graphic characteristics, pregnancy history, and various were included in the NBDPS. Patent ductus arteriosus health conditions and exposures before and during and patent foramen ovale, which are often related to pregnancy from mothers of cases and controls.A preg- preterm birth, were not included. Congenital heart nancy calendar mailed in advance of the interview was defect (CHD) cases were further categorized as simple, used to help participants more accurately report timing associations, or complex.12 Most of the heart pheno- of exposures.Study mothers were asked about all medi- types analyzed in this study were simple CHDs (defined cations taken during the period from 3 months precon- as a single CHD or CHD “entity”) or common CHD ception through the end of pregnancy. Self-reported associations (eg, coarctation of the aorta + ventricular information was collected on timing, frequency, and septal defect [VSD]). Cases recorded as “atrial septal duration of medication use. The Slone Epidemiology defect (ASD) not otherwise specified” were viewed as Center Drug Dictionary was used to code all reported probably ASD secundum type and were counted as medications. Maternal periconceptional butalbital such in the main analysis. Certain study sites
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