{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T12:13:07Z","timestamp":1773058387728,"version":"3.50.1"},"reference-count":28,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2020,5,6]],"date-time":"2020-05-06T00:00:00Z","timestamp":1588723200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2020,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Safety data on clozapine use during pregnancy are limited. The aim of this study was to determine disproportionality in case safety reports on adverse pregnancy outcomes between clozapine and other antipsychotics (OAP) used during pregnancy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We included all reports of suspected adverse drug reactions (ADRs) to antipsychotics registered in the World Health Organization global individual case safety report (ICSR) database (VigiBase) in children younger than 2\u2009years and women aged 12\u201045\u2009years. A case\/non\u2010case approach was used to evaluate the association between several pregnancy\u2010related ADRs and clozapine exposure during pregnancy, using 2\u00d72 contingency tables to investigate disproportionality and Standard MedDRA Queries to select cases. Clozapine exposure was defined as all ICSR\u2010ADR combinations with clozapine as (one of) the suspected drug(s). Non\u2010exposure was defined as all ICSR\u2010ADR combinations with OAP as (one of) the suspected drug(s).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We identified 42\u2009236 unique ICSR\u2010ADR combinations related with clozapine exposure and 170\u2009710 with OAP exposure. Of these, 494 and 4645 ICSR\u2010ADR combinations involved adverse pregnancy outcomes related with clozapine exposure and OAP exposure respectively. Overall, no signal of disproportionate reporting associating clozapine with the studied adverse pregnancy outcomes was found compared with OAP exposure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Based on global pharmacovigilance data, we did not find any evidence that clozapine is less safe during pregnancy than OAP. Although this is not automatically equivalent to the relative safety of clozapine during pregnancy, these findings add to the convergence of proofs to allow final conclusions and decisions regarding the treatment of pregnant women with clozapine.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5016","type":"journal-article","created":{"date-parts":[[2020,5,7]],"date-time":"2020-05-07T03:55:25Z","timestamp":1588823725000},"page":"725-735","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Safety of clozapine use during pregnancy: Analysis of international pharmacovigilance data"],"prefix":"10.1002","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3070-3626","authenticated-orcid":false,"given":"Marieke M.","family":"Beex\u2010Oosterhuis","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacy Albert Schweitzer Hospital  Dordrecht The Netherlands"},{"name":"Department of General Practice and Elderly Care Medicine, EMGO Institute for Health and Care Research VU University Medical Center  Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amadou","family":"Samb","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eibert R.","family":"Heerdink","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands"},{"name":"Department of Clinical Pharmacy Utrecht University Medical Center  Utrecht The Netherlands"},{"name":"Research Group Innovation of Pharmaceutical Care University of Applied Sciences Utrecht  Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick C.","family":"Souverein","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arthur R.","family":"Van Gool","sequence":"additional","affiliation":[{"name":"Emergis  Goes The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronald H. 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