{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T18:14:32Z","timestamp":1789755272415,"version":"4.0.1"},"reference-count":76,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2024,9,25]],"date-time":"2024-09-25T00:00:00Z","timestamp":1727222400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Background\/Objectives: Monoclonal antibodies (mAbs) have revolutionized multiple myeloma (MM) treatment. However, post-marketing data on their neuropsychiatric safety are limited. This study aimed to evaluate neuropsychiatric adverse events (AEs) related to mAbs used for MM through a retrospective pharmacovigilance analysis using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database. Methods: Individual case safety reports (ICSRs) from 2015 to 2023 with at least one neuropsychiatric AE and one of the MM-approved mAbs as the suspected drug (i.e., daratumumab, elotuzumab, isatuximab, belantamab mafodotin, teclistamab, elranatamab, and talquentamab) were analyzed using descriptive and disproportionality approaches. Results: Unknown signals of disproportionate reporting (SDR) included the following: cerebral infarction for daratumumab (n = 45; reporting odds ratio (ROR) = 2.39, 95% confidence interval (CI) = 1.79\u20133.21; information component (IC) = 1.54, IC025\u2013IC075 = 1.05\u20131.9), elotuzumab (25; 7.61, 5.13\u201311.28; 3.03, 2.37\u20133.51), and isatuximab (10; 2.56, 1.38\u20134.76; 1.67, 0.59\u20132.4); mental status changes for daratumumab (40; 2.66, 1.95\u20133.63; 1.67, 1.14\u20132.04) and belantamab mafodotin (10; 4.23, 2.28\u20137.88; 2.3, 1.22\u20133.03); an altered state of consciousness for daratumumab (32; 1.97, 1.39\u20132.78; 1.32, 0.73\u20131.74) and belantamab mafodotin (6; 2.35, 1.05\u20135.23; 1.6, 0.19\u20132.52); Guillain-Barre syndrome (GBS) for daratumumab (23; 6.42, 4.26\u20139.69; 2.81, 2.11\u20133.3), isatuximab (8; 10.72, 5.35\u201321.48; 3.57, 2.35\u20134.37), and elotuzumab (3; 4.74, 1.53\u201314.7; 2.59, 0.52\u20133.8); and orthostatic intolerance for daratumumab (10; 12.54, 6.71\u201323.43; 3.75, 2.67\u20134.48) and elotuzumab (4; 28.31, 10.58\u201375.73; 5, 3.24\u20136.08). Conclusions: Our analysis highlighted several previously unacknowledged SDRs for MM-approved mAbs. Given the complex and not entirely understood etiology of some neuropsychiatric AEs, including GBS, further investigations are necessary.<\/jats:p>","DOI":"10.3390\/ph17101266","type":"journal-article","created":{"date-parts":[[2024,9,26]],"date-time":"2024-09-26T04:05:46Z","timestamp":1727323546000},"page":"1266","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Neuropsychiatric Adverse Events with Monoclonal Antibodies Approved for Multiple Myeloma: An Analysis from the FDA Adverse Event Reporting System"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8345-8679","authenticated-orcid":false,"given":"Giuseppe","family":"Cicala","sequence":"first","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-1681-1417","authenticated-orcid":false,"given":"Giulia","family":"Russo","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenza","family":"Santoro","sequence":"additional","affiliation":[{"name":"Department of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, 98125 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tindara","family":"Franchina","sequence":"additional","affiliation":[{"name":"Department of Human Pathology in Adulthood and Childhood Gaetano Barresi, University of Messina, 98125 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Silvestris","sequence":"additional","affiliation":[{"name":"Department of Human Pathology in Adulthood and Childhood Gaetano Barresi, University of Messina, 98125 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariacarmela","family":"Santarpia","sequence":"additional","affiliation":[{"name":"Department of Human Pathology in Adulthood and Childhood Gaetano Barresi, University of Messina, 98125 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2509-7449","authenticated-orcid":false,"given":"Edoardo","family":"Spina","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2019-4696","authenticated-orcid":false,"given":"Maria Antonietta","family":"Barbieri","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,9,25]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e538","DOI":"10.1016\/S1470-2045(14)70442-5","article-title":"International Myeloma Working Group Updated Criteria for the Diagnosis of Multiple Myeloma","volume":"15","author":"Rajkumar","year":"2014","journal-title":"Lancet Oncol."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Lapietra, G., Fazio, F., and Petrucci, M.T. 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