{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,4]],"date-time":"2025-10-04T08:07:37Z","timestamp":1759565257518,"version":"3.40.5"},"reference-count":23,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,7,2]],"date-time":"2021-07-02T00:00:00Z","timestamp":1625184000000},"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":[[2021,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The present case describes in detail a 55\u2010year\u2010old woman diagnosed with acute liver injury 3\u2009days after completion of the first treatment course with ulipristal acetate (UPA), 5\u00a0mg\/day orally for uterine fibroids causing persistent bleeding (treatment duration of 109\u2009days). Liver transplantation was performed approximately 6\u00a0weeks after UPA suspension, and a photograph of the explanted liver is presented. Of note, other common causes of acute liver injury, such as history of alcohol or other psychoactive substances abuse, viral hepatitis and autoimmune hepatitis or preexisting liver disease were all excluded. This case was reported to the European Medicines Agency (EMA) and contributed to the final recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) disclosed in January 2021. The causality assessment considered a probable case of drug\u2010induced liver injury as a consequence of UPA treatment, and the Roussel Uclaf Causality Assessment Method (RUCAM) was scored as unlikely. Although further studies are needed aiming to avoid confounding factors, this case suggests that liver function tests should be monitored during treatment with UPA.<\/jats:p>","DOI":"10.1111\/bcpt.13631","type":"journal-article","created":{"date-parts":[[2021,6,30]],"date-time":"2021-06-30T01:44:50Z","timestamp":1625017490000},"page":"278-282","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Acute liver failure requiring transplantation: A possible link to ulipristal acetate treatment?"],"prefix":"10.1111","volume":"129","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7430-6297","authenticated-orcid":false,"given":"Ricardo Jorge","family":"Dinis\u2010Oliveira","sequence":"first","affiliation":[{"name":"TOXRUN \u2013 Toxicology Research Unit, University Institute of Health Sciences Advanced Polytechnic and University Cooperative (CESPU), CRL  Gandra Portugal"},{"name":"Department of Public Health and Forensic Sciences, and Medical Education, Faculty of Medicine University of Porto  Porto Portugal"},{"name":"UCIBIO\u2010REQUIMTE, Laboratory of Toxicology, Department of Biological Sciences, Faculty of Pharmacy University of Porto  Porto Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7366-6765","authenticated-orcid":false,"given":"Duarte Nuno","family":"Vieira","sequence":"additional","affiliation":[{"name":"Faculty of Medicine University of Coimbra  Coimbra Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,7,2]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1103182"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijgo.12868"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2016.02.018"},{"key":"e_1_2_8_5_1","article-title":"Medical therapy for fibroids: what next for ulipristal acetate?","author":"Ekanem E","year":"2020","journal-title":"Adv Ther"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2018.06.044"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinre.2020.02.008"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/03602532.2021.1917599"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000000756"},{"key":"e_1_2_8_10_1","unstructured":"European Medicines Agency.Ulipristal acetate 5\u2009mg.https:\/\/www.ema.europa.eu\/en\/documents\/referral\/ulipristal-acetate-5mg-medicinal-products-article-31-referral-chmp-scientific-conclusions-prac_en.pdf. Amsterdam: European Medicines Agency;2020. Accessed 15 Jun 2021."},{"key":"e_1_2_8_11_1","unstructured":"European Medicines Agency.Ulipristal acetate 5\u2009mg.https:\/\/www.ema.europa.eu\/en\/medicines\/human\/referrals\/ulipristal\u2010acetate\u20105mg\u2010medicinal\u2010products. Amsterdam: European Medicines Agency;2021. Accessed 15 Jun 2021."},{"key":"e_1_2_8_12_1","unstructured":"European Medicines Agency.Esmya Article\u201020 Procedure \u2010 PRAC Assessment Report.https:\/\/www.ema.europa.eu\/en\/documents\/referral\/esmya-article-20-procedure-prac-assessment-report_en.pdf. London: European Medicines Agency;2018. Accessed 15 Jun 2021."},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23696"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms17010014"},{"key":"e_1_2_8_15_1","unstructured":"NCBI.LiverTox: clinical and research information on drug\u2010induced liver injury. Roussel Uclaf Causality Assessment Method (RUCAM) in drug induced liver injury. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; updated 4 May 2019.https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK548272\/. Accessed 15 Jun 2021."},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-020-00960-1"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.28323"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13256-016-1123-0"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-020-01004-4"},{"key":"e_1_2_8_20_1","article-title":"Ulipristal acetate and liver\u2010injuries: while Esmya is revoked, EllaOne is allowed in repeated self\u2010administrations possibly exceeding UPA toxic\u2010dosing with Esmya","author":"Mozzanega B","year":"2020","journal-title":"J Hepatol"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-020-00975-8"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.109.162651"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinre.2020.03.020"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/jcpt.12065"}],"container-title":["Basic &amp; Clinical Pharmacology &amp; Toxicology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcpt.13631","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bcpt.13631","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcpt.13631","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T21:01:41Z","timestamp":1693342901000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/bcpt.13631"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,2]]},"references-count":23,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021,9]]}},"alternative-id":["10.1111\/bcpt.13631"],"URL":"https:\/\/doi.org\/10.1111\/bcpt.13631","archive":["Portico"],"relation":{},"ISSN":["1742-7835","1742-7843"],"issn-type":[{"type":"print","value":"1742-7835"},{"type":"electronic","value":"1742-7843"}],"subject":[],"published":{"date-parts":[[2021,7,2]]},"assertion":[{"value":"2021-05-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-06-24","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-07-02","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}