Topiramate use during pregnancy and major congenital malformations in multiple populations

Birth Defects Research Part A - Clinical and Molecular Teratology

Volumn 103, Issue 4, 2015, Pages 269-275

  Tennis, Patricia ^a   Chan, K Arnold ^b   Curkendall, Suellen M ^c   Li, De Kun ^d   Mines, Daniel ^e   Peterson, Craig ^f   Andrews, Elizabeth B ^a   Calingaert, Brian ^a   Chen, Hong Y ^d   Deshpande, Gaurav ^e   Everage, Nicholas ^b   Holick, Crystal N ^e   Meyer, Nicole M ^g   Nkhoma, Ella T ^e   Quinn, Sherry ^b   Rothman, Kenneth J ^a   Esposito, Daina B ^e  

^a RTI HEALTH SOLUTIONS   (United States)

^b OPTUM   (United States)

^c Kaiser Foundation Research Institute ^*  (United States)

^d KAISER PERMANENTE   (United States)

^e HEALTHCORE INC   (United States)

^f Menlo Park and VIVUS   (United States)

^g IBM WATSON HEALTH   (United States)

Author keywords

Cardiac malformations; Epidemiology; FORTRESS; Major malformations; Topiramate

Indexed keywords

TOPIRAMATE; FRUCTOSE;

ADULT; AORTA COARCTATION; ARTICLE; COHORT ANALYSIS; CONGENITAL HEART MALFORMATION; CONGENITAL MALFORMATION; CONTROLLED STUDY; DISEASE ASSOCIATION; DRUG INDICATION; ELECTRONIC MEDICAL RECORD; EPILEPSY; FEMALE; FIRST TRIMESTER PREGNANCY; HEALTH INSURANCE; HEART VENTRICLE SEPTUM DEFECT; HUMAN; HYPOSPADIAS; MAJOR CLINICAL STUDY; MAJOR CONGENITAL MALFORMATION; MIGRAINE; PRENATAL DRUG EXPOSURE; PREVALENCE; PRIORITY JOURNAL; UROGENITAL TRACT MALFORMATION; ABNORMALITIES, DRUG-INDUCED; ANALOGS AND DERIVATIVES; PREGNANCY; RISK ASSESSMENT; UNITED STATES;

ABNORMALITIES, DRUG-INDUCED; COHORT STUDIES; FEMALE; FRUCTOSE; HUMANS; PREGNANCY; PREVALENCE; RISK ASSESSMENT; UNITED STATES;

EID: 84937517490     PISSN: 15420752     EISSN: 15420760     Source Type: Journal    
DOI: 10.1002/bdra.23357     Document Type: Article

References (17)

1. Andrade SE, Scott PE, Davis RL, et al. 2013. Validity of health plan and birth certificate data for pregnancy research. Pharmacoepidemiol Drug Saf 22:7-15.
2. Bahat Dinur A, Koren G, Matok I, et al. 2013. Fetal safety of macrolides. Antimicrob Agents Chemother 57:3307-3311.
3. Cragan JD, Gilboa SM. 2009. Including prenatal diagnoses in birth defects monitoring: experience of the Metropolitan Atlanta Congenital Defects Program. Birth Defects Res A Clin Mol Teratol 85:20-29.
4. Everage NJ, Esposito DB, Zhou L, et al. Positive predictive values of algorithms for ascertainment of major congenital malformations in administrative databases. Presented at the 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, August 25-28, 2013, Montréal, Canada. Pharmacoepidemiol Drug Saf 2013;22(Suppl 1):1-521.
5. Gadde KM, Allison DB, Ryan DH, et al. 2011. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet 377:1341-1352.
6. Green MW, Seeger JD, Peterson C, et al. 2012. Utilization of topiramate during pregnancy and risk of birth defects. Headache 52:1070-1084.
7. Hernández-Díaz S, Smith CR, Shen A, et al; North American AED Pregnancy Registry; North American AED Pregnancy Registry. 2012. Comparative safety of antiepileptic drugs during pregnancy. Neurology 78:1692-1699.
8. Hunt S, Russell A, Smithson WH, et al. 2008. Topiramate in pregnancy: preliminary experience from the UK Epilepsy and Pregnancy Register. Neurology 71:272-276.
9. Korelitz JJ, McNally DL, Masters MN, et al. 2013. Prevalence of thyrotoxicosis, antithyroid medication use, and complications among pregnant women in the United States. Thyroid 23:758-765.
10. Kornum JB, Nielsen RB, Pedersen L, et al. 2010. Use of selective serotonin-reuptake inhibitors during early pregnancy and risk of congenital malformations: updated analysis. Clin Epidemiol 2:29-36.
11. Margulis AV, Mitchell AA, Gilboa SM, et al; National Birth Defects Prevention Study. 2012. Use of topiramate in pregnancy and risk of oral clefts. Am J Obstet Gynecol 207:405.e1-e7.
12. Metropolitan Atlanta Congenital Defects Program (MACDP). 2007. 40th anniversary edition surveillance report. Appendix A: data tables and figures. Birth Defects Res A Clin Mol Teratol 79:94-177.
13. Mines D, Tennis P, Curkendall SM, et al. 2014. Topiramate use in pregnancy and the birth prevalence of oral clefts. Pharmacoepidemiol Drug Saf 23:1017-1025.
14. Mitchell AA. 2012. Studies of drug-induced birth defects. In: Strom BL, Kimmel SI, Hennessy S, editors. Pharmacoepidemiology. West Sussex, UK: Wiley Blackwell. pp. 487-504.
15. Mølgaard-Nielsen D, Hviid A. 2011. Newer-generation antiepileptic drugs and the risk of major birth defects. JAMA 305:1996-2002.
16. Schneider DJ. 2012. The patent ductus arteriosus in term infants, children, and adults. Semin Perinatol 36:146-153.
17. Vajda FJ, O'Brien TJ, Graham J, et al. 2013. Associations between particular types of fetal malformation and antiepileptic drug exposure in utero. Acta Neurol Scand 128:228-234.