{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T08:56:16Z","timestamp":1791276976513,"version":"4.1.0"},"reference-count":26,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,2]],"date-time":"2026-08-02T00:00:00Z","timestamp":1785628800000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the risk of major congenital anomalies (MCAs) and other adverse outcomes following prenatal exposure to modafinil.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This retrospective cohort study used the French national healthcare database (SNDS) to include singleton children born between January 2009 and September 2024 of women aged 15\u201355\u2009years. Prenatal exposure to psychostimulants was defined as maternal dispensation during pregnancy. Children prenatally exposed to modafinil were compared with two control groups: children prenatally exposed to methylphenidate and children prenatally unexposed to any psychostimulant matched to the exposed group using propensity\u2010score matching (PSM). Outcomes included MCAs, neurodevelopmental disorders (NDs), and specialized consultations. Analyses included descriptive statistics, survival analysis, regression models, and dose\u2013response analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 10\u2009955\u2009766 included children, 865 were prenatally exposed to modafinil and 950 to methylphenidate. Exposure to modafinil during the first trimester of pregnancy was statistically associated with increased risk of MCA compared to methylphenidate, although the confidence interval was wide and close to the null (aRR\u2009=\u20091.77 [1.01\u20133.07]). Comparison with PS\u2010matched unexposed population indicated a possible modest increase in risk, albeit with a wide confidence interval crossing the null (aRR\u2009=\u20091.23 [0.76\u20131.99]), showing no clear association. Occurrence of NDs (aHR\u2009=\u20090.96 [0.56\u20131.65]), and specialized consultations (aHR\u2009=\u20091.08 [0.91\u20131.28]) were similar in the modafinil and PSM unexposed groups but were higher in the methylphenidate group (NDs: aHR\u2009=\u20090.48 [0.29\u20130.80]; specialized consultations: aHR\u2009=\u20090.71 [0.59\u20130.85]).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study shows no increase in neurodevelopmental risk, while a moderate MCA risk cannot be excluded.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70448","type":"journal-article","created":{"date-parts":[[2026,8,2]],"date-time":"2026-08-02T22:49:36Z","timestamp":1785710976000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Prenatal Exposure to Modafinil and the Risk of Major Congenital Anomalies and Other Adverse Neonatal and Pediatric Outcomes"],"prefix":"10.1002","volume":"35","author":[{"given":"Melinda","family":"Kanoun","sequence":"first","affiliation":[{"name":"Unit\u00e9 de Recherche Clinique Necker Cochin AP\u2010HP  Paris France"},{"name":"Universit\u00e9 Paris Cit\u00e9, Inserm, Pharmacologie et \u00e9valuations des th\u00e9rapeutiques chez l'enfant et la femme enceinte  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Na\u00efm","family":"Bouazza","sequence":"additional","affiliation":[{"name":"Unit\u00e9 de Recherche Clinique Necker Cochin AP\u2010HP  Paris France"},{"name":"Universit\u00e9 Paris Cit\u00e9, Inserm, Pharmacologie et \u00e9valuations des th\u00e9rapeutiques chez l'enfant et la femme enceinte  Paris France"},{"name":"CIC\u20101419 Inserm, Cochin\u2010Necker  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Marc","family":"Treluyer","sequence":"additional","affiliation":[{"name":"Unit\u00e9 de Recherche Clinique Necker Cochin AP\u2010HP  Paris France"},{"name":"Universit\u00e9 Paris Cit\u00e9, Inserm, Pharmacologie et \u00e9valuations des th\u00e9rapeutiques chez l'enfant et la femme enceinte  Paris France"},{"name":"CIC\u20101419 Inserm, Cochin\u2010Necker  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-2398-0396","authenticated-orcid":false,"given":"Mathis","family":"Collier","sequence":"additional","affiliation":[{"name":"Unit\u00e9 de Recherche Clinique Necker Cochin AP\u2010HP  Paris France"},{"name":"Universit\u00e9 Paris Cit\u00e9, Inserm, Pharmacologie et \u00e9valuations des th\u00e9rapeutiques chez l'enfant et la femme enceinte  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,2]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2004.03.002"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.nmd.2012.02.005"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.5664\/jcsm.26970"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40263\u2010025\u201001175\u20107"},{"key":"e_1_2_11_6_1","unstructured":"Government of Canada HC \u201cALERTEC (Modafinil) and the Risk of Congenital Anomalies\u2013Recalls Advisories and Safety Alerts\u2014Canada.Ca [Internet] \u201dGovernment of Canada Health Canada Marketed Health Products 2021 https:\/\/recalls\u2010rappels.canada.ca\/en\/alert\u2010recall\/alertec\u2010modafinil\u2010and\u2010risk\u2010congenital\u2010anomalies."},{"key":"e_1_2_11_7_1","unstructured":"European Medicines Agency \u201cPRAC Recommendations on 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