Evidence map›Paper›PMID 41995784›Full record

ArticleDrug safety2026

Risk of Fetal Exposure to Teratogenic Medications: Development of Evidence for the Teratogenic Risk Impact and Mitigation (TRIM) Tool.

Yanning Wang, Celeste L Y Ewig, Nicole E Smolinski, Gita A Toyserkani, Cynthia LaCivita, Esther H Zhou, Gerald J Dal Pan, Thuy Nhu Thai, Judith C Maro, Sonja A Rasmussen and 1 more

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Article in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

11 authors.

Yanning WangDepartment of Pharmaceutical Outcomes and Policy, University of Florida, 1889 Museum Road, Gainesville, FL, 32611, USA.
Celeste L Y EwigDepartment of Pharmaceutical Outcomes and Policy, University of Florida, 1889 Museum Road, Gainesville, FL, 32611, USA.
Nicole E SmolinskiDepartment of Pharmaceutical Outcomes and Policy, University of Florida, 1889 Museum Road, Gainesville, FL, 32611, USA.
Gita A ToyserkaniCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Cynthia LaCivitaIndependent, Potomac, MD, USA.
Esther H ZhouCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Gerald J Dal PanCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Thuy Nhu ThaiDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Judith C MaroDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Sonja A RasmussenDepartment of Genetic Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Almut G WintersteinDepartment of Pharmaceutical Outcomes and Policy, University of Florida, 1889 Museum Road, Gainesville, FL, 32611, USA. almut@ufl.edu.ORCID http://orcid.org/0000-0002-6518-5961

Funding

U.S. Food and Drug Administration HHS75F40121C00188
6 · The paper itself

Abstract

introductionPreventing fetal exposure to teratogenic medications is a public health priority. The Teratogenic Risk Impact Mitigation (TRIM) tool has been developed to support regulatory decisions regarding risk mitigation programs. One of the explicit TRIM criteria requires medication-specific quantification of fetal exposure risk.

objectiveTo develop and compare population-based estimates of fetal exposure risk for medications with known teratogenicity.

methodsThis retrospective US population-based cohort study used claims data from Medicaid and MarketScan

resultsAmong 59,815,213 female enrollees (31,905,714 Medicaid; 27,909,499 MarketScan), 12,819,073 used ≥ 1 teratogenic medication. Fetal exposure rates ranged from 0-1512 per 1000 user-years (tertiles: 2.9 and 11.5), with higher rates observed in Medicaid. Medications that exhibited high rates included fluconazole (1512/1000 user-years, 95% CI 1504.5-1518.6) and sulfamethoxazole/trimethoprim (295, 95% CI 233.6-492.2), vedolizumab (53, 95% CI 46.7-60.2) and several anticonvulsants. Two medications, phentermine-topiramate, with a current risk mitigation program, and fingolimod, with a released risk management program, were also ranked in the highest tertile. Fetal exposures to medications prescribed for acute conditions occurred more frequently through initiation during pregnancy, while those for chronic medications occurred mostly because of conception during treatment.

conclusionsFetal exposure risks differed across medications and populations, influenced by treatment chronicity, relevant teratogenic risk periods, and patient demographics, which can inform the development of risk mitigation programs. Data gleaned from this analysis will be used as an ordinal "fetal exposure risk" criterion score in our development of the TRIM decision tool.

Indexed as

Abnormalities, Drug-InducedTeratogensAdolescentAdultChildCohort StudiesDatabases, FactualFemaleHumansMiddle AgedPregnancyPrenatal Exposure Delayed EffectsRetrospective StudiesRisk AssessmentRisk Evaluation and MitigationUnited StatesTeratogens

Identifiers

PMID41995784
PMCPMC13225234

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