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Multivariable logistic regression estimated reporting odds ratios (RORs) for serious ADRs, death, and thromboembolic events according to demographical and clinical covariates.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 1095 Individual Case Safety Reports (ICSRs) reporting idarucizumab (72%) or andexanet alfa (28%) as suspected\/interacting agents were collected. Most of the subjects were males (44.5%), with a median age of 78 years, and exposed to only one suspected\/interacting medication (73.6%). ADRs were defined as serious in 88.6% of cases, with a total of 614 (56.1%) fatal cases. Compared to patients without concomitant medications, probability of serious ADRs and death were both higher in those receiving\u2009\u2265\u20095 concomitant medications in the idarucizumab subgroup (ROR 4.04 and 1.66, respectively) and in those receiving 1\u20134 concomitant medications in the andexanet alfa subgroup (ROR 5.66 and 4.80, respectively). Moreover, the probability of thromboembolic events was significantly lower for subjects aged\u2009&gt;\u200975 years (ROR for 75\u201384 years 0.55; ROR for \u2265\u200985 years 0.50).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>In real-world, ADRs associated with idarucizumab and andexanet alfa use are generally serious, resulting in death in a high percentage of subjects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Clinicians should pay particular attention when managing individuals needing these drugs, especially if vulnerable and requiring polytherapy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s40520-025-03025-4","type":"journal-article","created":{"date-parts":[[2025,4,7]],"date-time":"2025-04-07T00:59:35Z","timestamp":1743987575000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Safety of direct oral anticoagulants reversal agents in older patients: an analysis of individual case safety reports of adverse drug reaction from VigiBase\u00ae"],"prefix":"10.1007","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1071-6120","authenticated-orcid":false,"given":"Giada","family":"Crescioli","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9666-0438","authenticated-orcid":false,"given":"Niccol\u00f2","family":"Lombardi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9778-1522","authenticated-orcid":false,"given":"Elena","family":"Arzenton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-2615-0756","authenticated-orcid":false,"given":"Nicoletta","family":"Luxi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6950-3875","authenticated-orcid":false,"given":"Stefano","family":"Fumagalli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9644-499X","authenticated-orcid":false,"given":"Roberto","family":"Bonaiuti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-3231-5273","authenticated-orcid":false,"given":"Costanza","family":"Cacini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8273-7377","authenticated-orcid":false,"given":"Guido","family":"Mannaioni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1147-7296","authenticated-orcid":false,"given":"Gianluca","family":"Trifir\u00f2","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5108-5807","authenticated-orcid":false,"given":"Ugo","family":"Moretti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5259-2026","authenticated-orcid":false,"given":"Alfredo","family":"Vannacci","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,4,7]]},"reference":[{"key":"3025_CR1","unstructured":"Dabigatran versus warfarin in patients with atrial fibrillation - PubMed https:\/\/pubmed.ncbi.nlm.nih.gov\/19717844\/. 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The information comes from a variety of sources, and the probability that the suspected adverse event is drug-related is not the same in all cases; the information does not represent the opinion of the UMC or WHO.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"UMC statement"}},{"value":"Over the last 3 years, Professor Gianluca Trifir\u00f2 has participated in advisory boards and seminars funded by Sanofi, MSD, Eli Lilly, Sobi, Celgene, Daichii Sankyo, Novo Nordisk, Gilead, and Amgen. He is the scientific coordinator of the academic spin-off \u201cINSPIRE srl\u201d, which has received funding from several pharmaceutical companies (i.e., PTC Pharmaceuticals, Kiowa Kirin, Shonogi, Shire, Novo Nordisk, and Daichii Sankyo) for conducting observational studies. Additionally, he is currently a consultant for Viatris in a legal case concerning an adverse reaction to sertraline. None of these listed activities are related to the topic of the article. All other authors have no conflicts of interest to disclose.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"120"}}