{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T18:45:21Z","timestamp":1791225921726,"version":"4.1.0"},"reference-count":43,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2015,5,20]],"date-time":"2015-05-20T00:00:00Z","timestamp":1432080000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2015,8]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>We assessed the hepatic safety of novel oral anticoagulants (NOACs) analyzing the publicly available US\u2010FDA adverse event reporting system (FAERS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We extracted reports of drug\u2010induced liver injury (DILI) associated with NOACs, including acute liver failure (ALF) events. Based on US marketing authorizations, we performed disproportionality analyses, calculating reporting odds ratios (RORs) with 95% confidence interval (CI), also to test for event\u2010 and drug\u2010related competition bias, and case\u2010by\u2010case evaluation for concomitant medications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>DILI reports represented 3.7% (<jats:italic>n<\/jats:italic> = 146) and 1.7% (<jats:italic>n<\/jats:italic> = 222) of all reports for rivaroxaban and dabigatran, respectively. No statistically significant association was found for dabigatran, in primary and secondary analyses. Disproportionality signals emerged for rivaroxaban in primary analysis (ALF: <jats:italic>n<\/jats:italic> = 25, ROR = 2.08, 95% CI 1.34, 3.08). In a large proportion of DILI reports concomitant hepatotoxic and\/or interacting drugs were recorded: 42% and 37% (rivaroxaban and dabigatran, respectively), especially statins, paracetamol and amiodarone. Among ALF reports, fatal outcome occurred in 49% of cases (44% and 51%, rivaroxaban and dabigatran, respectively), whereas rapid onset of the event (&lt;1 week) was detected in 46% of patients (47% and 44%, respectively).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The disproportionality signal for rivaroxaban calls for further comparative population\u2010based studies to characterize and quantify the actual DILI risk of NOACs, taking into account drug\u2010 and patient\u2010related risk factors. As DILI is unpredictable, our findings strengthen the role of (a) timely pharmacovigilance to detect post\u2010marketing signals of DILI through FAERS and other data sources, (b) clinicians to assess early, on a case\u2010by\u2010case basis, the potential responsibility of NOACs when they diagnose a liver injury.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.12611","type":"journal-article","created":{"date-parts":[[2015,2,16]],"date-time":"2015-02-16T07:44:57Z","timestamp":1424072697000},"page":"285-293","source":"Crossref","is-referenced-by-count":70,"title":["Liver injury with novel oral anticoagulants: assessing post\u2010marketing reports in the US Food and Drug Administration adverse event reporting system"],"prefix":"10.1111","volume":"80","author":[{"given":"Emanuel","family":"Raschi","sequence":"first","affiliation":[{"name":"Department of Medical and Surgical Sciences University of Bologna  Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabetta","family":"Poluzzi","sequence":"additional","affiliation":[{"name":"Department of Medical and Surgical Sciences University of Bologna  Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ariola","family":"Koci","sequence":"additional","affiliation":[{"name":"Department of Medical and Surgical Sciences University of Bologna  Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Salvo","sequence":"additional","affiliation":[{"name":"University of Bordeaux, U657  F33000 Bordeaux France"},{"name":"INSERM U657  F33000 Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoine","family":"Pariente","sequence":"additional","affiliation":[{"name":"University of Bordeaux, U657  F33000 Bordeaux France"},{"name":"INSERM U657  F33000 Bordeaux France"},{"name":"CIC Bordeaux CIC1401  F33000 Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurizio","family":"Biselli","sequence":"additional","affiliation":[{"name":"Department of Medical and Surgical Sciences University of Bologna  Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ugo","family":"Moretti","sequence":"additional","affiliation":[{"name":"Department of Public Health and Community Medicine University of Verona  Verona Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1212-2817","authenticated-orcid":false,"given":"Nicholas","family":"Moore","sequence":"additional","affiliation":[{"name":"University of Bordeaux, U657  F33000 Bordeaux France"},{"name":"INSERM U657  F33000 Bordeaux France"},{"name":"CIC Bordeaux CIC1401  F33000 Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrizio","family":"De Ponti","sequence":"additional","affiliation":[{"name":"Department of Medical and 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