{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T14:44:43Z","timestamp":1779201883105,"version":"3.51.4"},"reference-count":47,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2022,8,28]],"date-time":"2022-08-28T00:00:00Z","timestamp":1661644800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Data on the safety of paternal use of 5\u2010aminosalicylic acid (5\u2010ASA) prior to conception are lacking, and the safety of maternal use of 5\u2010ASA during pregnancy has not been examined in nationwide data.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>To examine offspring outcomes after paternal pre\u2010conception use of 5\u2010ASA, and after maternal use during pregnancy<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This nationwide cohort study was based on Danish health registries. The study population included live born singletons of patients with ulcerative colitis (UC) or Crohn's disease (CD). Paternal exposure included 2168 children fathered by men treated with 5\u2010ASA, and 7732 unexposed. Maternal exposure included 3618 children exposed <jats:italic>in utero<\/jats:italic> to 5\u2010ASA, and 7128 unexposed. The outcomes were pre\u2010term birth, small for gestational age (SGA), low Apgar score and major congenital abnormalities (CAs) according to EUROCAT guidelines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The vast majority of fathers and mothers used mesalazine. In children fathered by men with UC using 5\u2010ASA, we found no increased risk of pre\u2010term birth, SGA or low Apgar score. The hazard ratio (HR) of CAs was 1.30 (95% CI 0.92\u20131.85). In children of fathers with CD, the odds ratio (OR) of SGA was 1.52 (95% CI 0.65\u20133.55). After maternal 5\u2010ASA exposure, the OR of SGA in children of women with UC was 1.46 (95% CI: 0.93\u20132.30); for CAs in children of women with CD, HR was 1.44 (95% CI 0.84\u20132.47).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Paternal and maternal use of 5\u2010ASA was safe across offspring outcomes; none of the findings reached statistical significance. The safety of 5\u2010ASA formulations that are used infrequently cannot be settled here.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.17189","type":"journal-article","created":{"date-parts":[[2022,8,29]],"date-time":"2022-08-29T04:59:10Z","timestamp":1661749150000},"page":"1349-1360","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["The safety of paternal and maternal use of 5\u2010aminosalicylic acid during conception and pregnancy: a nationwide cohort study"],"prefix":"10.1111","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9514-3033","authenticated-orcid":false,"given":"Bente Mertz","family":"N\u00f8rg\u00e5rd","sequence":"first","affiliation":[{"name":"Center for Clinical Epidemiology Odense University Hospital  Odense C Denmark"},{"name":"Research Unit of Clinical Epidemiology, Department of Clinical Research University of Southern Denmark  Odense C Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2720-4404","authenticated-orcid":false,"given":"Sonia","family":"Friedman","sequence":"additional","affiliation":[{"name":"Center for Clinical Epidemiology Odense University Hospital  Odense C Denmark"},{"name":"Center for Crohn's and Colitis, Brigham and Women's Hospital, Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jens","family":"Kjeldsen","sequence":"additional","affiliation":[{"name":"Department of Medical Gastroenterology S Odense University Hospital  Odense C Denmark"},{"name":"Research Unit of Medical Gastroenterology, Department of Clinical Research University of Southern Denmark  Odense C Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan","family":"Nielsen","sequence":"additional","affiliation":[{"name":"Center for Clinical Epidemiology Odense University Hospital  Odense C Denmark"},{"name":"Research Unit of Clinical Epidemiology, Department of Clinical Research University of Southern Denmark  Odense C Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,8,28]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/MEG.0000000000001074"},{"issue":"3","key":"e_1_2_11_3_1","first-page":"768","article-title":"Sexual and reproductive issues for men with inflammatory bowel disease","volume":"104","author":"Feagins LA","year":"2009","journal-title":"Am J Gastroenterol"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40471-017-0098-8"},{"issue":"2","key":"e_1_2_11_5_1","first-page":"116","article-title":"Paternal drug exposure: effects on reproduction and progeny","volume":"6","author":"Joffe JM","year":"1982","journal-title":"Semin Perinatol"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0095-5108(18)31161-8"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.1254400"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/19396368.2016.1274791"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/bies.201300113"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/ibd.21120"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2021.04.045"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/ibd\/izac038"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(98)70628-6"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.52.2.243"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2007.11.010"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2007.01216.x"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jju006"},{"issue":"12","key":"e_1_2_11_18_1","first-page":"2201","article-title":"Safety of topical 5\u2010aminosalicylic acid in pregnancy","volume":"92","author":"Bell CM","year":"1997","journal-title":"Am J Gastroenterol"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/0016-5085(93)90949-D"},{"issue":"5","key":"e_1_2_11_20_1","first-page":"443","article-title":"Pentasa (mesalazine) and pregnancy","volume":"49","author":"Jonville\u2010Bera AP","year":"1994","journal-title":"Therapie"},{"issue":"2","key":"e_1_2_11_21_1","first-page":"75","article-title":"5\u2010Aminosalicylic acid in pregnancy: clinical report","volume":"26","author":"Trallori G","year":"1994","journal-title":"Ital J Gastroenterol"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S91125"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10654-018-0356-1"},{"issue":"4","key":"e_1_2_11_24_1","first-page":"441","article-title":"The Danish civil registration system. 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