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Antiepileptic drug use, folic acid supplementation, and congenital abnormalities: a population-based case-control study.
BJOG 2008; 115(1):98-103BJOG

Abstract

OBJECTIVE

To investigate whether folic acid supplementation in early pregnancy modifies the association between the prevalence of congenital abnormalities in the offspring and maternal use of carbamazepine (CBZ), phenobarbital (PB), phenytoin (PHT), and primidone (PRI).

DESIGN

A population-based case-control study.

SETTING

The Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA) (1980-1996) and its information on children from the Hungarian Congenital Abnormality Registry and the Hungarian National Birth Registry.

POPULATION

Children with congenital abnormalities (cases; n= 20 792, of whom 148 had been exposed to antiepileptic drugs [AEDs]) and unaffected children (controls; n= 38 151, of whom 184 had been exposed to AEDs).

METHODS

Information on drug exposure and background variables for the mothers were collected from antenatal logbooks, discharge summaries, and structured questionnaires completed by the mothers at the time of HCCSCA registration.

MAIN OUTCOME MEASURES

Congenital abnormalities detected at termination of pregnancy, at birth or until 3 months of age according to CBZ, PB, PHT, or PRI exposure at 5-12 weeks from first day of the last menstrual period (LMP), stratified by folic acid supplementation.

RESULTS

Compared with children unexposed to AEDs and folic acid, the odds ratio of congenital abnormalities was 1.47 (95% CI 1.13-1.90) in children exposed to AEDs without folic acid supplementation and 1.27 (95% CI 0.85-1.89) for children exposed to AEDs with folic acid supplementation.

CONCLUSION

The results indicate that the risk of congenital abnormalities in children exposed in utero to CBZ, PB, PHT, and PRI is reduced but not eliminated by folic acid supplementation at 5-12 weeks from LMP. The statistical precision in our study is limited due to rarity of the exposures, and further studies are needed.

Authors+Show Affiliations

The Danish Epidemiology Science Centre, Department of Epidemiology, Institute of Public Health, University of Aarhus, Aarhus, Denmark.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17999694

Citation

Kjaer, D, et al. "Antiepileptic Drug Use, Folic Acid Supplementation, and Congenital Abnormalities: a Population-based Case-control Study." BJOG : an International Journal of Obstetrics and Gynaecology, vol. 115, no. 1, 2008, pp. 98-103.
Kjaer D, Horvath-Puhó E, Christensen J, et al. Antiepileptic drug use, folic acid supplementation, and congenital abnormalities: a population-based case-control study. BJOG. 2008;115(1):98-103.
Kjaer, D., Horvath-Puhó, E., Christensen, J., Vestergaard, M., Czeizel, A. E., Sørensen, H. T., & Olsen, J. (2008). Antiepileptic drug use, folic acid supplementation, and congenital abnormalities: a population-based case-control study. BJOG : an International Journal of Obstetrics and Gynaecology, 115(1), pp. 98-103.
Kjaer D, et al. Antiepileptic Drug Use, Folic Acid Supplementation, and Congenital Abnormalities: a Population-based Case-control Study. BJOG. 2008;115(1):98-103. PubMed PMID: 17999694.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antiepileptic drug use, folic acid supplementation, and congenital abnormalities: a population-based case-control study. AU - Kjaer,D, AU - Horvath-Puhó,E, AU - Christensen,J, AU - Vestergaard,M, AU - Czeizel,A E, AU - Sørensen,H T, AU - Olsen,J, Y1 - 2007/11/12/ PY - 2007/11/15/pubmed PY - 2008/1/18/medline PY - 2007/11/15/entrez SP - 98 EP - 103 JF - BJOG : an international journal of obstetrics and gynaecology JO - BJOG VL - 115 IS - 1 N2 - OBJECTIVE: To investigate whether folic acid supplementation in early pregnancy modifies the association between the prevalence of congenital abnormalities in the offspring and maternal use of carbamazepine (CBZ), phenobarbital (PB), phenytoin (PHT), and primidone (PRI). DESIGN: A population-based case-control study. SETTING: The Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA) (1980-1996) and its information on children from the Hungarian Congenital Abnormality Registry and the Hungarian National Birth Registry. POPULATION: Children with congenital abnormalities (cases; n= 20 792, of whom 148 had been exposed to antiepileptic drugs [AEDs]) and unaffected children (controls; n= 38 151, of whom 184 had been exposed to AEDs). METHODS: Information on drug exposure and background variables for the mothers were collected from antenatal logbooks, discharge summaries, and structured questionnaires completed by the mothers at the time of HCCSCA registration. MAIN OUTCOME MEASURES: Congenital abnormalities detected at termination of pregnancy, at birth or until 3 months of age according to CBZ, PB, PHT, or PRI exposure at 5-12 weeks from first day of the last menstrual period (LMP), stratified by folic acid supplementation. RESULTS: Compared with children unexposed to AEDs and folic acid, the odds ratio of congenital abnormalities was 1.47 (95% CI 1.13-1.90) in children exposed to AEDs without folic acid supplementation and 1.27 (95% CI 0.85-1.89) for children exposed to AEDs with folic acid supplementation. CONCLUSION: The results indicate that the risk of congenital abnormalities in children exposed in utero to CBZ, PB, PHT, and PRI is reduced but not eliminated by folic acid supplementation at 5-12 weeks from LMP. The statistical precision in our study is limited due to rarity of the exposures, and further studies are needed. SN - 1471-0528 UR - https://www.unboundmedicine.com/medline/citation/17999694/Antiepileptic_drug_use_folic_acid_supplementation_and_congenital_abnormalities:_a_population_based_case_control_study_ L2 - https://doi.org/10.1111/j.1471-0528.2007.01552.x DB - PRIME DP - Unbound Medicine ER -