{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T20:47:49Z","timestamp":1788814069583,"version":"build-2803163510"},"reference-count":26,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T00:00:00Z","timestamp":1748476800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:p>Tyrosine kinase inhibitors (TKIs) targeting BCR::ABL1 have greatly improved the survival of patients with chronic myeloid leukemia (CML), and their teratogenicity appears as an important factor for individuals of childbearing potential. This study aims to investigate pregnancy and fetal\/newborn adverse outcomes resulting from exposure to BCR::ABL1\u2010TKIs during pregnancy. For this disproportionality analysis, we used the WHO's global VigiBase up to January 2024, and included reports involving pregnancy, antineoplastic treatment during pregnancy, and cancer. The exposure group consisted of reports mentioning BCR::ABL1\u2010TKIs at any time during pregnancy. The primary outcome was the reporting odds ratio (ROR) of maternal\u2010fetal complications in the BCR::ABL1\u2010TKIs group compared to other anticancer treatments. The analysis included 3,389 reports (TKI\u2009=\u2009969; other\u2009=\u20092,420). In the BCR::ABL1\u2010TKI\u2010exposed group, the mean age was 28.9\u2009years, and 724 patients (92.2%) were treated for CML. BCR::ABL1\u2010TKIs were mainly imatinib (<jats:italic>n<\/jats:italic>\u2009=\u2009642, 66.3%), nilotinib (<jats:italic>n<\/jats:italic>\u2009=\u2009218, 22.5%), and dasatinib (<jats:italic>n<\/jats:italic>\u2009=\u2009127, 13.1%) reported without other non\u2010TKI anticancer agents(92.3%). Compared to other anticancer drugs, overreported outcomes with TKIs included hydrops fetalis (ROR\u2009=\u200913 [95%CI\u2009=\u20091.5\u2013110], <jats:italic>P<\/jats:italic>\u2009=\u20090.009), polyhydramnios (ROR\u2009=\u20095 [1.3\u201320], <jats:italic>P<\/jats:italic>\u2009=\u20090.02), and threatened preterm labor (ROR\u2009=\u200910 [1.1\u201390], <jats:italic>P<\/jats:italic>\u2009=\u20090.03). When analyzing specific molecule effects, hydrops fetalis (ROR\u2009=\u200927 [5.4\u2013130], <jats:italic>P<\/jats:italic>\u2009=\u20090.001) and polyhydramnios (ROR\u2009=\u200913 [3.3\u201354], <jats:italic>P<\/jats:italic>\u2009=\u20090.004) were overreported with dasatinib. In this large cohort of 969 individuals exposed to TKIs during pregnancy, dasatinib use was associated with most BCR::ABL1\u2010TKI\u2010specific toxicities and should be avoided during pregnancy. Fewer or no adverse events were overreported with imatinib and nilotinib.<\/jats:p>","DOI":"10.1002\/cpt.3730","type":"journal-article","created":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T23:23:57Z","timestamp":1748561037000},"page":"705-714","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["<scp>BCR<\/scp>::<scp>ABL1<\/scp> Tyrosine Kinase Inhibitors During Pregnancy, a Disproportionality Analysis of Vigibase"],"prefix":"10.1002","volume":"118","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6064-3783","authenticated-orcid":false,"given":"Aur\u00e9lie","family":"Cabannes\u2010Hamy","sequence":"first","affiliation":[{"name":"Hematology Centre Hospitalier de Versailles Site Andr\u00e9 Mignot  Le Chesnay\u2010Rocquencourt France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5165-9743","authenticated-orcid":false,"given":"Rayan","family":"Kabirian","sequence":"additional","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory RT2Lab, INSERM, U932 Immunity and Cancer, Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5009-3936","authenticated-orcid":false,"given":"Floriane","family":"Jochum","sequence":"additional","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory RT2Lab, INSERM, U932 Immunity and Cancer, Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Department of Gynecology Strasbourg University Hospital  Strasbourg France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6797-0237","authenticated-orcid":false,"given":"Kevin","family":"Bihan","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Institut National de la Sant\u00e9 et de la Recherche M\u00e9dicale (INSERM), Assistance Publique \u2013 H\u00f4pitaux de Paris (AP\u2010HP), Clinical Investigation Center (CIC\u20101901), Sorbonne Universit\u00e9 Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital  Paris France"},{"name":"Paris Piti\u00e9\u2010St Antoine Regional Pharmacovigilance Center, Medical Pharmacology Department APHP Sorbonne University Hospital Group  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7877-719X","authenticated-orcid":false,"given":"Elise","family":"Dumas","sequence":"additional","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory RT2Lab, INSERM, U932 Immunity and Cancer, Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Department of Mathematics \u00c9cole Polytechnique F\u00e9d\u00e9rale de Lausanne  Lausanne Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6443-8883","authenticated-orcid":false,"given":"Florence","family":"Coussy","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3875-4011","authenticated-orcid":false,"given":"Enora","family":"Laas","sequence":"additional","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory RT2Lab, INSERM, U932 Immunity and Cancer, Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Department of Breast, Gynecological and Reconstructive Surgery Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3238-4494","authenticated-orcid":false,"given":"Philippe","family":"Rousselot","sequence":"additional","affiliation":[{"name":"Hematology Centre Hospitalier de Versailles Site Andr\u00e9 Mignot  Le Chesnay\u2010Rocquencourt France"},{"name":"University of Versailles Paris\u2010Saclay  Versailles France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvain","family":"Choquet","sequence":"additional","affiliation":[{"name":"Department of Hematology Assistance Publique \u2013 H\u00f4pitaux de Paris (AP\u2010HP), Sorbonne Universit\u00e9, Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5254-3483","authenticated-orcid":false,"given":"Madalina","family":"Uzunov","sequence":"additional","affiliation":[{"name":"Department of Hematology Assistance Publique \u2013 H\u00f4pitaux de Paris (AP\u2010HP), Sorbonne Universit\u00e9, Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0627-4347","authenticated-orcid":false,"given":"Laurent","family":"Salomon","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Surgery, Fetal Medicine and Imaging H\u00f4pital Necker\u2010Enfants Malades  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2318-3589","authenticated-orcid":false,"given":"Fabien","family":"Reyal","sequence":"additional","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory RT2Lab, INSERM, U932 Immunity and Cancer, Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Department of Breast, Gynecological and Reconstructive Surgery Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Department of Surgical Oncology Institut Godinot  Reims France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4430-3022","authenticated-orcid":false,"given":"Anne\u2010Sophie","family":"Hamy","sequence":"additional","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory RT2Lab, INSERM, U932 Immunity and Cancer, Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Department of Medical Oncology Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3064-7043","authenticated-orcid":false,"given":"Paul","family":"Gougis","sequence":"additional","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory RT2Lab, INSERM, U932 Immunity and Cancer, Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Department of Pharmacology, Institut National de la Sant\u00e9 et de la Recherche M\u00e9dicale (INSERM), Assistance Publique \u2013 H\u00f4pitaux de Paris (AP\u2010HP), Clinical Investigation Center (CIC\u20101901), Sorbonne Universit\u00e9 Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital  Paris France"},{"name":"Department of Medical Oncology, Sorbonne Universit\u00e9 Assistance Publique \u2013 H\u00f4pitaux de Paris (AP\u2010HP), Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital, Institut Universitaire de Canc\u00e9rologie  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,5,29]]},"reference":[{"key":"e_1_2_11_1_1","doi-asserted-by":"publisher","DOI":"10.1067\/S0002-9378(03)00537-4"},{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2002-0279"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2015.73"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1182\/hematology.2019000050"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2017.253"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2007-10-114900"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.24186"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2022.826703"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.2217\/ijh-2020-0004"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/1756-8722-2-42"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2019-0109"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm11071801"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjh.19491"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.therap.2020.02.022"},{"key":"e_1_2_11_15_1","unstructured":"EMA.Guideline on Good Pharmacovigilance Practices (GVP) \u2013 Product\u2010 or Population\u2010Specific Considerations III: Pregnant and Breastfeeding Women(2019)."},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.39934"},{"key":"e_1_2_11_17_1","doi-asserted-by":"crossref","unstructured":"Gougis P. Hamy A.\u2010S. Jochum F. Bihan K.&Abbar B.Immune Checkpoint Inhibitor Use During Pregnancy and Outcomes in Pregnant Individuals and Newborns(2024).","DOI":"10.1001\/jamanetworkopen.2024.5625"},{"key":"e_1_2_11_18_1","unstructured":"https:\/\/www.equator\u2010network.org\/reporting\u2010guidelines\/strobe\/."},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12687-018-0384-2"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1080\/10428194.2020.1849672"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopha.2020.111134"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1097\/CAD.0b013e328352a8fe"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1177\/1078155217745710"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.01096-2017"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2011.04037.x"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1001"}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.3730","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,15]],"date-time":"2025-08-15T05:58:25Z","timestamp":1755237505000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.3730"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,29]]},"references-count":26,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,9]]}},"alternative-id":["10.1002\/cpt.3730"],"URL":"https:\/\/doi.org\/10.1002\/cpt.3730","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,29]]},"assertion":[{"value":"2024-12-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-13","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-29","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}