Cited by 266Pregnancy and Medication ImpactPharmacological Effects and Toxicity StudiesCardiovascular Issues in Pregnancy

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Lithium Use in Pregnancy and the Risk of Cardiac Malformations

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Patorno, Elisabetta, Huybrechts, Krista F., Bateman, Brian T., Cohen, Jacqueline M., Desai, Rishi J., Mogun, Helen, Cohen, Lee S., Hernandez-Diaz, Sonia·2017·New England Journal of Medicine

DOI 10.1056/nejmoa1612222PMC PMC5667676

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Abstract

BACKGROUND: There has been concern that exposure to lithium early in pregnancy may be associated with a marked increase in the risk of Ebstein's anomaly (a right ventricular outflow tract obstruction defect) in infants and overall congenital cardiac defects, but data are conflicting and limited. METHODS: We conducted a cohort study involving 1,325,563 pregnancies in women who were enrolled in Medicaid and who delivered a live-born infant between 2000 and 2010. We examined the risk of cardiac malformations among infants exposed to lithium during the first trimester as compared with unexposed infants and, in secondary analyses, with infants exposed to another commonly used mood stabilizer, lamotrigine. Risk ratios and 95% confidence intervals were estimated with control for psychiatric and medical conditions, medications, and other potential confounders. RESULTS: Cardiac malformations were present in 16 of the 663 infants exposed to lithium (2.41%), 15,251 of the 1,322,955 nonexposed infants (1.15%), and 27 of the 1945 infants exposed to lamotrigine (1.39%). The adjusted risk ratio for cardiac malformations among infants exposed to lithium as compared with unexposed infants was 1.65 (95% confidence interval [CI], 1.02 to 2.68). The risk ratio was 1.11 (95% CI, 0.46 to 2.64) for a daily dose of 600 mg or less, 1.60 (95% CI, 0.67 to 3.80) for 601 to 900 mg, and 3.22 (95% CI, 1.47 to 7.02) for more than 900 mg. The prevalence of right ventricular outflow tract obstruction defects was 0.60% among lithium-exposed infants versus 0.18% among unexposed infants (adjusted risk ratio, 2.66; 95% CI, 1.00 to 7.06). Results were similar when lamotrigine-exposed infants were used as the reference group. CONCLUSIONS: Maternal use of lithium during the first trimester was associated with an increased risk of cardiac malformations, including Ebstein's anomaly; the magnitude of this effect was smaller than had been previously postulated. (Funded by the National Institute of Mental Health.).

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Authors: Patorno, E., Huybrechts, K. F., Bateman, B. T., Cohen, J. M., Desai, R. J., Mogun, H., Cohen, L. S., & Hernandez-Diaz, S.
Affiliations: Brigham and Women's Hospital (US)
ORCID: Patorno, Elisabetta
Huybrechts, Krista F.
Bateman, Brian T.
Cohen, Jacqueline M.
Desai, Rishi J.
Cohen, Lee S.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2017-06-08
Volume: 376
Issue: 23
Pages: 2245-2254
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1612222
PMC: PMC5667676
OpenAlex: W2621713722
Cited by: 265
References: 42
Citations by year: 2026: 19 · 2025: 18 · 2024: 44 · 2023: 23 · 2022: 23 · 2021: 24 · 2020: 33 · 2019: 41 · 2018: 28 · 2017: 12
FWCI: 29.23
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Institute of Mental Health (R01MH100216, K01MH099141)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmacological Effects and Toxicity Studies
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Issues in Pregnancy
Keywords: lithium, pregnancy, cardiac anomalies, Ebstein's anomaly, right ventricular outflow tract obstruction, lamotrigine, mood stabilizers, first trimester exposure, congenital heart disease, maternal medication use, dose-response relationship, bipolar disorder in pregnancy, antipsychotic safety in pregnancy, prenatal drug exposure, live birth
MeSH terms: Lamotrigine, Adult, Anticonvulsants, Antidepressive Agents, Bipolar Disorder, Female, Heart Defects, Congenital, Humans, Infant, Infant, Newborn, Pregnancy, Pregnancy Complications, Pregnancy Trimester, First, Triazines, Cohort Studies, Prevalence, Lithium Compounds, Antimanic Agents, Young Adult

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