{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T12:17:16Z","timestamp":1783426636879,"version":"3.54.6"},"reference-count":23,"publisher":"MDPI AG","issue":"13","license":[{"start":{"date-parts":[[2026,6,28]],"date-time":"2026-06-28T00:00:00Z","timestamp":1782604800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Bilastine is a long-acting, nonsedating antihistamine used to treat allergic conditions. Human pregnancy experience with bilastine remains limited. Objectives: The primary aim was to evaluate the risk of major anomalies following first-trimester bilastine exposure. Secondary endpoints included additional pregnancy outcomes. Methods: This observational, prospective cohort study included women counseled by the Israeli Teratology Information Service regarding first-trimester bilastine exposure between July 2019 and June 2023. Participants were contacted by telephone for follow-up using a structured questionnaire. Pregnancy outcomes were compared with fexofenadine-exposed pregnancies. The data analysis, comparison, and presentation followed the recommendations of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guide. Results: Follow-up was obtained for 36 pregnancies with at least first-trimester bilastine exposure. The median daily bilastine dose was 20 mg, with treatment discontinued at a median gestational age of 5 + 6 weeks. First-trimester bilastine exposure was not associated with an increased risk of major anomalies [bilastine: 2\/33, 6.1% vs. fexofenadine: 2\/27, 7.4%; crude OR 0.81, 95% CI 0.11\u20136.14]. No pattern of malformations was observed. Rates of live-birth, miscarriage, and pregnancy termination were 91.7%, 5.6%, and 2.8% in the bilastine group, and 72.2%, 19.4%, and 8.3% in the fexofenadine group, respectively. Conclusions: This cohort study, although small, provides preliminary reassurance for counseling regarding inadvertent early pregnancy exposure to bilastine. Larger studies are needed to validate these findings.<\/jats:p>","DOI":"10.3390\/jcm15135035","type":"journal-article","created":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T08:45:20Z","timestamp":1782722720000},"page":"5035","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pregnancy Outcome Following First-Trimester Exposure to Bilastine: A Comparative Observational Cohort Study from the Israeli Teratology Information Service"],"prefix":"10.3390","volume":"15","author":[{"given":"Reem","family":"Hegla-Murad","sequence":"first","affiliation":[{"name":"The Israeli Teratology Information Service, Ministry of Health, Jerusalem 9446724, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Svetlana","family":"Shechtman","sequence":"additional","affiliation":[{"name":"The Israeli Teratology Information Service, Ministry of Health, Jerusalem 9446724, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orna","family":"Diav-Citrin","sequence":"additional","affiliation":[{"name":"The Israeli Teratology Information Service, Ministry of Health, Jerusalem 9446724, Israel"},{"name":"Department of Medical Neurobiology, The Hebrew University and Hadassah Medical School, Jerusalem 9112102, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,6,28]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s12948-015-0008-x","article-title":"Bilastine: New insight into antihistamine treatment","volume":"13","author":"Ridolo","year":"2015","journal-title":"Clin. Mol. Allergy"},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Mizuguchi, H., Wakugawa, T., Sadakata, H., Kamimura, S., Takemoto, M., Nakagawa, T., Yabumoto, M., Kitamura, Y., Takeda, N., and Fukui, H. (2020). Elucidation of Inverse Agonist Activity of Bilastine. Pharmaceutics, 12.","DOI":"10.3390\/pharmaceutics12060525"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"371","DOI":"10.2165\/00126839-200506060-00005","article-title":"Preclinical pharmacology of bilastine, a new selective histamine H1 receptor antagonist: Receptor selectivity and in vitro antihistaminic activity","volume":"6","author":"Labeaga","year":"2005","journal-title":"Drugs R&D"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1185\/03007995.2011.648263","article-title":"Establishing the place in therapy of bilastine in the treatment of allergic rhinitis according to ARIA: Evidence review","volume":"28","author":"Bousquet","year":"2012","journal-title":"Curr. Med. Res. Opin."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1011","DOI":"10.1007\/s40261-016-0447-2","article-title":"Pharmacokinetics, Pharmacodynamics and Population Pharmacokinetic\/Pharmacodynamic Modelling of Bilastine, a Second-Generation Antihistamine, in Healthy Japanese Subjects","volume":"36","author":"Togawa","year":"2016","journal-title":"Clin. Drug Investig."},{"key":"ref_6","unstructured":"Aralez Pharmaceuticals Trading DAC (2026, April 19). BLEXTEN\u00ae Product Monograph. Available online: https:\/\/searchlightpharma.com\/wp-content\/uploads\/2023\/10\/Blexten-PM-ENG-Aug2021.pdf."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"25","DOI":"10.3109\/01480545.2012.682652","article-title":"Preclinical toxicity profile of oral bilastine","volume":"35","author":"Lucero","year":"2012","journal-title":"Drug Chem. Toxicol."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"e12130","DOI":"10.1002\/clt2.12130","article-title":"Worldwide prevalence of rhinitis in adults: A review of definitions and temporal evolution","volume":"12","author":"Bousquet","year":"2022","journal-title":"Clin. Transl. Allergy"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"950","DOI":"10.1016\/j.jaip.2024.12.032","article-title":"Biological sex differences in rhinitis prevalence among adults in the United States: An \u201cAll of Us\u201d Research Program database analysis","volume":"13","author":"Lee","year":"2025","journal-title":"J. Allergy Clin. Immunol. Pract."},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Ventura, M.T., Giuliano, A.F.M., Boni, E., Brussino, L., Buquicchio, R., Conte, M., Costantino, M.T., Crivellaro, M.A., Giuliani, I.M.R., and Losa, F. (2025). Gender and allergy: Mechanisms, clinical phenotypes, and therapeutic response\u2014A position paper from the Societ\u00e0 Italiana di Allergologia, Asma ed Immunologia Clinica (SIAAIC). Int. J. Mol. Sci., 26.","DOI":"10.3390\/ijms26199605"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"3133","DOI":"10.1111\/all.14950","article-title":"Effects of pregnancy on chronic urticaria: Results of the PREG-CU UCARE study","volume":"76","author":"Krause","year":"2021","journal-title":"Allergy"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"e201316","DOI":"10.1001\/jamapediatrics.2020.1316","article-title":"Association between fexofenadine use during pregnancy and fetal outcomes","volume":"174","author":"Andersson","year":"2020","journal-title":"JAMA Pediatr."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1016\/j.reprotox.2008.05.064","article-title":"Using observational cohort data for studying drug effects on pregnancy outcome\u2014Methodological considerations","volume":"26","author":"Schaefer","year":"2008","journal-title":"Reprod. Toxicol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"331","DOI":"10.1016\/j.reprotox.2005.03.012","article-title":"Post-marketing surveillance system for drugs in pregnancy\u201415 years experience of ENTIS","volume":"20","author":"Schaefer","year":"2005","journal-title":"Reprod. Toxicol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/j.reprotox.2020.11.005","article-title":"Pregnancy outcome following in-utero exposure to ondansetron: A prospective comparative observational study","volume":"99","author":"Sakran","year":"2021","journal-title":"Reprod. Toxicol."},{"key":"ref_16","unstructured":"EUROCAT Central Registry (2022). EUROCAT Guide 1.5: Instructions for the Registration of Congenital Anomalies, University of Ulster. Available online: https:\/\/eu-rd-platform.jrc.ec.europa.eu\/eurocat\/data-collection\/guidelines-for-data-registration_en."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"805","DOI":"10.1097\/EDE.0b013e3181577511","article-title":"Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and elaboration","volume":"18","author":"Vandenbroucke","year":"2007","journal-title":"Epidemiology"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1667","DOI":"10.1517\/14740338.2014.970164","article-title":"Antihistamines and birth defects: A systematic review of the literature","volume":"13","author":"Gilboa","year":"2014","journal-title":"Expert Opin. Drug Saf."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"115","DOI":"10.3233\/JRS-2001-263","article-title":"Monitoring of maternal drug use and infant congenital malformations. Does loratadine cause hypospadias?","volume":"14","year":"2001","journal-title":"Int. J. Risk Saf. Med."},{"key":"ref_20","first-page":"106","article-title":"No increased risk of infant hypospadias after maternal use of loratadine in early pregnancy","volume":"3","author":"Olausson","year":"2006","journal-title":"Int. J. Med. Sci."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"950","DOI":"10.1016\/j.jaci.2017.03.050","article-title":"Allergic rhinitis and its impact on asthma (ARIA) guidelines\u20142016 revision","volume":"140","author":"Bousquet","year":"2017","journal-title":"J. Allergy Clin. Immunol."},{"key":"ref_22","unstructured":"Pawankar, R., Canonica, G.W., Holgate, S.T., Lockey, R.F., and Blaiss, M. (2013). WAO White Book on Allergy: Update 2013, World Allergy Organization."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"445","DOI":"10.1080\/03007995.2019.1681134","article-title":"Bilastine: A lifetime companion for the treatment of allergies","volume":"36","author":"Church","year":"2020","journal-title":"Curr. Med. Res. Opin."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/15\/13\/5035\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T11:40:07Z","timestamp":1783424407000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/15\/13\/5035"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,28]]},"references-count":23,"journal-issue":{"issue":"13","published-online":{"date-parts":[[2026,7]]}},"alternative-id":["jcm15135035"],"URL":"https:\/\/doi.org\/10.3390\/jcm15135035","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,28]]}}}