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Med."],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec id=\"S0033291722002859_sec_a1\"><jats:title>Background<\/jats:title><jats:p>Evidence on neonatal withdrawal syndrome following antidepressant intrauterine exposure is limited, particularly for antidepressants other than selective serotonin reuptake inhibitor (SSRIs).<\/jats:p><\/jats:sec><jats:sec id=\"S0033291722002859_sec_a2\" sec-type=\"methods\"><jats:title>Methods<\/jats:title><jats:p>In our case\/non-case pharmacovigilance study, based on VigiBase<jats:sup>\u00ae<\/jats:sup>, the WHO database of suspected adverse drug reactions, we estimated reporting odds ratio (ROR) and the Bayesian information component (IC) with 95% confidence\/credibility intervals (CI) as measures of disproportionate reporting of antidepressant-related neonatal withdrawal syndrome. Antidepressants were first compared to all other medications, then to methadone, and finally within each class of antidepressants: SSRIs, tricyclics (TCA) and other antidepressants. Antidepressants were ranked in terms of clinical priority, based on semiquantitative score ratings. Serious <jats:italic>v.<\/jats:italic> non-serious reports were compared.<\/jats:p><\/jats:sec><jats:sec id=\"S0033291722002859_sec_a3\" sec-type=\"results\"><jats:title>Results<\/jats:title><jats:p>A total of 406 reports of neonatal withdrawal syndrome in 379 neonates related to 15 antidepressants were included. Disproportionate reporting was detected for antidepressants as a group as compared to all other drugs (ROR: 6.18, 95% CI 5.45\u20137.01, IC: 2.07, 95% CI 1.92\u20132.21). Signals were found for TCAs (10.55, 95% CI 8.02\u201313.88), followed by other antidepressants (ROR: 5.90, 95% CI 4.74\u20137.36) and SSRIs (ROR: 4.68, 95% CI 4.04\u20135.42). Significant disproportionality emerged for all individual antidepressants except for bupropion, whereas no disproportionality for any antidepressant was detected <jats:italic>v.<\/jats:italic> methadone. Eleven antidepressants had a moderate clinical priority score and four had a weak one. Most frequent symptoms included respiratory symptoms (<jats:italic>n<\/jats:italic> = 106), irritability\/agitation (<jats:italic>n<\/jats:italic> = 75), tremor (<jats:italic>n<\/jats:italic> = 52) and feeding problems (<jats:italic>n<\/jats:italic> = 40).<\/jats:p><\/jats:sec><jats:sec id=\"S0033291722002859_sec_a4\" sec-type=\"conclusions\"><jats:title>Conclusions<\/jats:title><jats:p>Most antidepressants are associated with moderate signals of disproportionate reporting for neonatal withdrawal syndrome, which should be considered when prescribing an antidepressant during pregnancy, irrespective of class.<\/jats:p><\/jats:sec>","DOI":"10.1017\/s0033291722002859","type":"journal-article","created":{"date-parts":[[2022,9,21]],"date-time":"2022-09-21T06:11:05Z","timestamp":1663740665000},"page":"5645-5653","update-policy":"https:\/\/doi.org\/10.1017\/policypage","source":"Crossref","is-referenced-by-count":20,"title":["Neonatal withdrawal syndrome following in utero exposure to antidepressants: a disproportionality analysis of VigiBase, the WHO spontaneous reporting database"],"prefix":"10.1017","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7257-2962","authenticated-orcid":false,"given":"C.","family":"Gastaldon","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9778-1522","authenticated-orcid":false,"given":"E.","family":"Arzenton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0487-7996","authenticated-orcid":false,"given":"E.","family":"Raschi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7902-9014","authenticated-orcid":false,"given":"O.","family":"Spigset","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6482-8593","authenticated-orcid":false,"given":"D.","family":"Papola","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2248-9524","authenticated-orcid":false,"given":"G.","family":"Ostuzzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5108-5807","authenticated-orcid":false,"given":"U.","family":"Moretti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Trifir\u00f2","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1073-9282","authenticated-orcid":false,"given":"C.","family":"Barbui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3851-4117","authenticated-orcid":false,"given":"G.","family":"Schoretsanitis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2022,9,21]]},"reference":[{"key":"S0033291722002859_ref40","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)17865-9"},{"key":"S0033291722002859_ref35","doi-asserted-by":"publisher","DOI":"10.1007\/s10549-020-06001-w"},{"key":"S0033291722002859_ref18","doi-asserted-by":"crossref","first-page":"385","DOI":"10.2165\/00002018-200629050-00003","article-title":"Under-reporting of adverse drug reactions: A systematic review","volume":"29","author":"Hazell","year":"2006","journal-title":"Drug Safety"},{"key":"S0033291722002859_ref6","doi-asserted-by":"publisher","DOI":"10.1080\/13651501.2022.2057331"},{"key":"S0033291722002859_ref32","doi-asserted-by":"publisher","DOI":"10.1248\/yakushi.15-00224-5"},{"key":"S0033291722002859_ref49","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0069-z"},{"key":"S0033291722002859_ref55","doi-asserted-by":"publisher","DOI":"10.1159\/000516031"},{"key":"S0033291722002859_ref58","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2022.891336"},{"key":"S0033291722002859_ref33","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200730100-00007"},{"key":"S0033291722002859_ref37","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-020-00928-1"},{"key":"S0033291722002859_ref52","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1157"},{"key":"S0033291722002859_ref22","doi-asserted-by":"publisher","DOI":"10.1111\/acps.13367"},{"key":"S0033291722002859_ref43","doi-asserted-by":"publisher","DOI":"10.1016\/j.jogc.2020.09.026"},{"key":"S0033291722002859_ref31","doi-asserted-by":"publisher","DOI":"10.1111\/aogs.13872"},{"key":"S0033291722002859_ref11","doi-asserted-by":"publisher","DOI":"10.1136\/gpsych-2019-100183"},{"key":"S0033291722002859_ref51","unstructured":"Uppsala Monitoring Centre, U. 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