{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T04:54:28Z","timestamp":1789016068613,"version":"build-2803163510"},"reference-count":15,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2020,12,16]],"date-time":"2020-12-16T00:00:00Z","timestamp":1608076800000},"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":["Basic Clin Pharma Tox"],"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Ondansetron is an effective antiemetic that is being widely used as a second\u2010line treatment option for severe nausea and vomiting of pregnancy in accordance with clinical guidelines. The safety of ondansetron during pregnancy has\u2014following publication of controversial and seemingly contradictory results\u2014been subject to considerable academic turmoil, specifically with respect to the risk of congenital cardiac malformations and oral cleft. In July 2019, the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) released an updated, comprehensive assessment report on the use of ondansetron in the first trimester. The ensuing Summary of Product Characteristics (SmPC) was updated in November 2019 with important changes to section on \u201cFertility, pregnancy and lactation.\u201d The SmPC now states that ondansetron should not be used in the first trimester of pregnancy. ENTIS, The European Network of Teratology Information Services, believes that the implementation of this regulatory step\u2014which has important clinical consequences\u2014is insufficiently substantiated and is not serving the interest of pregnant women with severe nausea and vomiting. Herein, we discuss the underlying evidence and argue the case against the EMA decision.<\/jats:p>","DOI":"10.1111\/bcpt.13541","type":"journal-article","created":{"date-parts":[[2020,12,4]],"date-time":"2020-12-04T14:57:52Z","timestamp":1607093872000},"page":"579-582","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Ondansetron in pregnancy revisited: Assessment and pregnancy labelling by the European Medicines Agency (EMA) &amp; Pharmacovigilance Risk Assessment Committee (PRAC)"],"prefix":"10.1111","volume":"128","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0591-7187","authenticated-orcid":false,"given":"Per","family":"Damkier","sequence":"first","affiliation":[{"name":"Department of Clinical Biochemistry &amp; Pharmacology Odense University Hospital Odense Denmark"},{"name":"Department of Clinical Research University of Southern Denmark Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yusuf Cem","family":"Kaplan","sequence":"additional","affiliation":[{"name":"Terafar \u2010 Izmir Katip Celebi University Teratology Information, Training and Research Center Izmir Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Svetlana","family":"Shechtman","sequence":"additional","affiliation":[{"name":"The Israeli Teratology Information Service Ministry of Health Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orna","family":"Diav\u2010Citrin","sequence":"additional","affiliation":[{"name":"The Israeli Teratology Information Service Ministry of Health, and the Hebrew University Hadassah Medical School Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matteo","family":"Cassina","sequence":"additional","affiliation":[{"name":"Clinical Genetics Unit Department of Women\u2019s and Children\u2019s Health University of Padua Padua Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corinna","family":"Weber\u2010Schoendorfer","sequence":"additional","affiliation":[{"name":"Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin Corporate Member of Freie Universit\u00e4t Berlin Humboldt\u2010Universit\u00e4t zu Berlin, and Berlin Institute of Health Pharmacovigilance Institute for Embryotoxicology Institute of Clinical Pharmacology and Toxicology Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,12,16]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"The Management of Nausea and Vomiting of Pregnancy and Hyperemesis Gravidarum (Green\u2010top Guideline No. 69)[Internet]. Royal College of Obstetricians & Gynaecologists. [cited 2020 Feb 25]. Available from:https:\/\/www.rcog.org.uk\/en\/guidelines\u2010research\u2010services\/guidelines\/gtg69\/"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.15662"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4185"},{"key":"e_1_2_6_5_1","doi-asserted-by":"crossref","unstructured":"Committee on Practice Bulletins\u2010Obstetrics.ACOG Practice Bulletin No. 189: Nausea And Vomiting Of Pregnancy. Obstet Gynecol. 2018;131:e15\u201330.","DOI":"10.1097\/AOG.0000000000002456"},{"key":"e_1_2_6_6_1","unstructured":"Updated Signal assessment report on birth defects following in\u2010utero exposure during the first trimester of pregnancy arising from recent publications with ondansetron[Internet]. 2019 [cited 2020 Feb 25]. Available from:https:\/\/www.ema.europa.eu\/en\/documents\/prac\u2010recommendation\/updated\u2010signal\u2010assessment\u2010report\u2010birth\u2010defects\u2010following\u2010utero\u2010exposure\u2010during\u2010first\u2010trimester_en.pdf"},{"key":"e_1_2_6_7_1","unstructured":"Ondansetron 4 mg film\u2010coated tablets \u2010 Summary of Product Characteristics (SmPC) \u2010 (emc)[Internet]. [cited 2020 Feb 25]. Available from:https:\/\/www.medicines.org.uk\/emc\/product\/5222\/smpc#PREGNANCY"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2019.03.001"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.18307"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2018.10.010"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-323-40139-5.00055-3"},{"key":"e_1_2_6_12_1","unstructured":"Affidavit of April Zambelli\u2010Weiner January 9 2019 (Doc. No. 1272). Available from:https:\/\/www.govinfo.gov\/content\/pkg\/USCOURTS\u2010mad\u20101_15\u2010md\u201002657\/pdf\/USCOURTS\u2010mad\u20101_15\u2010md\u201002657\u201016.pdfAccessed august 18 2020"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.18587"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyz255"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-319-40697-8_10"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamapediatrics.2020.1325"}],"container-title":["Basic &amp; Clinical Pharmacology &amp; Toxicology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcpt.13541","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bcpt.13541","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcpt.13541","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T05:22:07Z","timestamp":1693545727000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/bcpt.13541"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,16]]},"references-count":15,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2021,4]]}},"alternative-id":["10.1111\/bcpt.13541"],"URL":"https:\/\/doi.org\/10.1111\/bcpt.13541","archive":["Portico"],"relation":{"has-preprint":[{"id-type":"doi","id":"10.22541\/au.158465422.20540674","asserted-by":"object"}]},"ISSN":["1742-7835","1742-7843"],"issn-type":[{"value":"1742-7835","type":"print"},{"value":"1742-7843","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,16]]},"assertion":[{"value":"2020-09-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-11-30","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-16","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}