Risk of Congenital Ocular Anomaly After Prenatal Exposure to Medications: A EUROmediCAT Study

BackgroundIn Europe, the prevalence of congenital ocular anomaly (COA) is estimated at 3.7 per 10,000 births. While certain COAs have a genetic origin, the cause for most patients remains unknown. The role of medications administered during pregnancy in COA genesis in humans is unclear. ObjectiveTo...

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Detalhes bibliográficos
Autores: Cifuentes, EA, Beau, A, Caillet, A, Frémont, F, Neville, AJ, Ballardini, E, Dolk, H, Loane, M, Garne, E, Khoshnood, B, Lelong, N, Rissmann, A, O'Mahony, M, Pierini, A, Gatt, M, Bergman, JEH, Krawczynski, MR, Bielenska, AL, de Garibay, LJEG, Carbonell, CC, Addor, MC, Tucker, D, Jordan, S, Den Hond, E, Nelen, V, Barisic, I, Rouget, F, Randrianaivo, H, Hoareau, J, Perthus, I, Courtade-Saïdi, M, Damase-Michel, C, Dubucs, C
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Recursos:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:dnet:r-fisabio___::14f3f6c60480cb8077378c0e48bf568f
Acesso em linha:https://fisabio.portalinvestigacion.com/publicaciones/20946
Access Level:acceso abierto
Palavra-chave:congenital ocular anomaly
in utero exposure
medications
pharmacology
pregnancy
Descrição
Resumo:BackgroundIn Europe, the prevalence of congenital ocular anomaly (COA) is estimated at 3.7 per 10,000 births. While certain COAs have a genetic origin, the cause for most patients remains unknown. The role of medications administered during pregnancy in COA genesis in humans is unclear. ObjectiveTo investigate any association between fetal exposure in the first trimester of pregnancy to medications and the occurrence of COA. MethodsWe conducted a case-malformed-control study using data on 298,351 cases registered as having congenital anomalies (CA) from 19 registries and one healthcare database in 13 European countries. Two analyses were performed: (i) A signal confirmation analysis of signals from the literature, examining associations between COA and specific medications (nitrofurantoin, NSAIDs, opioids, alprazolam, antihypertensives, asthma medications, pyridoxine, and hydroxyethylrutoside). (ii) A signal detection analysis of all medications reported in the database. ResultsWe identified 4185 COA cases and 232,718 nongenetic and 38,409 genetic controls. We confirmed the association between prenatal opioid exposure and COA (aROR: 2.66, 95% CI: 1.18, 6.02, and 3.22, 95% CI: 1.35, 7.69, for nongenetic and genetic controls, respectively). Signal detection analysis revealed consistent associations for antiglaucoma preparations and miotics (p < 0.01) related to COA. Other associations included congenital cataracts and lens anomalies with desloratadine, congenital glaucoma with antiepileptics, and eyelid malformations with dermatological hydrocortisone. ConclusionsThis pharmacoepidemiological study in Europe analyzing COA following fetal medication exposure confirmed reported signals regarding opioids and COA and identified new associations. Validation in independent datasets is necessary to consolidate these findings.

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