Comparative safety of anti-epileptic drugs during pregnancy: a systematic review and network meta-analysis of congenital malformations and prenatal outcomes
Open accessAbstract
BACKGROUND: Pregnant women with epilepsy frequently experience seizures related to pregnancy complications and are often prescribed anti-epileptic drugs (AEDs) to manage their symptoms. However, less is known about the comparative safety of AED exposure in utero. We aimed to compare the risk of congenital malformations (CMs) and prenatal outcomes of AEDs in infants/children who were exposed to AEDs in utero through a systematic review and Bayesian random-effects network meta-analysis. METHODS: MEDLINE, EMBASE, and Cochrane CENTRAL were searched from inception to December 15, 2015. Two reviewers independently screened titles/abstracts and full-text papers for experimental and observational studies comparing mono- or poly-therapy AEDs versus control (no AED exposure) or other AEDs, then abstracted data and appraised the risk of bias. The primary outcome was incidence of major CMs, overall and by specific type (cardiac malformations, hypospadias, cleft lip and/or palate, club foot, inguinal hernia, and undescended testes). RESULTS: After screening 5305 titles and abstracts, 642 potentially relevant full-text articles, and 17 studies from scanning reference lists, 96 studies were eligible (n = 58,461 patients). Across all major CMs, many AEDs were associated with higher risk compared to control. For major CMs, ethosuximide (OR, 3.04; 95% CrI, 1.23-7.07), valproate (OR, 2.93; 95% CrI, 2.36-3.69), topiramate (OR, 1.90; 95% CrI, 1.17-2.97), phenobarbital (OR, 1.83; 95% CrI, 1.35-2.47), phenytoin (OR, 1.67; 95% CrI, 1.30-2.17), carbamazepine (OR, 1.37; 95% CrI, 1.10-1.71), and 11 polytherapies were significantly more harmful than control, but lamotrigine (OR, 0.96; 95% CrI, 0.72-1.25) and levetiracetam (OR, 0.72; 95% CrI, 0.43-1.16) were not. CONCLUSION: The newer generation AEDs, lamotrigine and levetiracetam, were not associated with significant increased risks of CMs compared to control, and were significantly less likely to be associated with children experiencing cardiac malformations than control. However, this does not mean that these agents are not harmful to infants/children exposed in utero. Counselling is advised concerning teratogenic risks when the prescription is written for a woman of childbearing age and before women continue with these agents when considering pregnancy, such as switching from polytherapy to monotherapy with evidence of lower risk and avoiding AEDs, such as valproate, that are consistently associated with CMs. These decisions must be balanced against the need for seizure control. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014008925.
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Anti-epileptic drugs, given at young age or during pregnancy, can have major neurodevelopmental implications.
“Important is also that the anti-epileptic drugs, given at young age or during pregnancy, can have major neurodevelopmental implications as well.”
From Development of prefrontal cortex (2022) · cites this paper as [392]
The Discussion reports congenital malformations and delayed physical development after exposure in utero, not neurodevelopmental effects. The Results (Literature search; page unavailable) explicitly say studies reporting neurological outcomes were excluded and reported in another paper. Our copy therefore does not establish neurodevelopmental implications from AEDs given during pregnancy or at a young age. (LLM, conf=0.78)
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- Authors
- Veroniki, A. A., Cogo, E., Rios, P., Straus, S. E., Finkelstein, Y., Kealey, R., Reynen, E., Soobiah, C., Thavorn, K., Hutton, B., Hemmelgarn, B. R., Yazdi, F., D’Souza, J., MacDonald, H., & Tricco, A. C.
- Affiliations
- St. Michael's Hospital (CA)
- University of Toronto (CA)
- University of Ottawa (CA)
- University of Calgary (CA)
- Corresponding author
- Tricco, Andrea C.
- ORCID
- Venue
- BMC Medicine
- Published
- 2017-05-05
- Volume
- 15
- Issue
- 1
- Pages
- 95-95
- ISSN
- 1741-7015 (ISSN-L)
- PMC
- PMC5418725
- OpenAlex
- W2611218072
- Cited by
- 339
- References
- 54
- Citations by year
- 2026: 23 · 2025: 33 · 2024: 50 · 2023: 45 · 2022: 39 · 2021: 46 · 2020: 44 · 2019: 31 · 2018: 22 · 2017: 4 · 2014: 1
- FWCI
- 5.17
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- BMC Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- TSpace (University of Toronto) (submittedVersion, cc-by)
- Libraries and Cultural Resources (University of Calgary) (submittedVersion)
- uO Research (University of Ottawa) (submittedVersion, public-domain)
- Spiral (Imperial College London) (submittedVersion, cc-by)
- Funders
- Canadian Institutes of Health Research (Banting Postdoctoral Fellowship Program, New Investigator Award in Knowledge Synthesis)
- Tier 1 Canada Research Chair in Knowledge Translation
- Alberta Heritage Foundation for Medical Research (CA)
- Tier 2 Canada Research Chair in Knowledge Synthesis
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmacological Effects and Toxicity Studies
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Health Sciences › Medicine › Psychiatry and Mental health › Epilepsy research and treatment
- Keywords
- antiepileptic drugs, pregnancy, congenital malformations, prenatal outcomes, drug safety, epilepsy in pregnancy, valproic acid, ethosuximide, topiramate, phenytoin, carbamazepine, phenobarbital, lamotrigine, cardiac anomalies, hypospadias, cleft lip and palate, clubfoot
- MeSH terms
- Abnormalities, Drug-Induced, Network Meta-Analysis, Adult, Anticonvulsants, Bayes Theorem, Child, Epilepsy, Female, Humans, Infant, Pregnancy, Pregnancy Complications, Pregnancy Outcome, Young Adult
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