{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T05:11:41Z","timestamp":1777957901453,"version":"3.51.4"},"reference-count":27,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T00:00:00Z","timestamp":1775779200000},"content-version":"vor","delay-in-days":9,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004423","name":"World Health Organization","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004423","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100020521","name":"Uppsala Monitoring Centre","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100020521","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Clindamycin is a common \u03b2\u2010lactam substitute for surgical prophylaxis. Whether peri\u2010operative disturbances in consciousness are disproportionately reported with clindamycin in global pharmacovigilance data remains unclear. Using WHO VigiBase (up to January 27, 2025), we performed a de\u2010duplicated case\/non\u2010case disproportionality analysis of Individual Case Safety Reports (ICSRs) co\u2010reporting \u2265\u20091 anesthetic or sedative. Cases were defined by the MedDRA HLT \u201cDisturbances in consciousness NEC.\u201d We estimated RORs and aRORs for clindamycin versus cefazolin and other peri\u2010operative comparators (metronidazole, vancomycin, ampicillin), adjusting for age group, sex, and co\u2010reported medications. K\u2010modes clustering characterized co\u2010reporting patterns among clindamycin reports. Sensitivity analyses excluded sepsis\u2010related terms\/vasopressors and applied a narrower outcome definition excluding syncope\/presyncope. Of 3623 clindamycin ICSRs, 159 (4.4%) included a consciousness\u2010disturbance term. Versus cefazolin, clindamycin generated a disproportionality signal (ROR 2.59, 95% CI 2.07\u20133.24; aROR 2.23, 95% CI 1.70\u20132.91), with similar estimates after excluding sepsis\/vasopressors (aROR 2.21, 95% CI 1.64\u20132.98) and syncope\/presyncope (aROR 2.11, 95% CI 1.60\u20132.79). Clustering suggested co\u2010reporting patterns consistent with lidocaine\u2010enriched older\u2010age reports, sedative\/anesthetic\u2010enriched younger\u2010age reports, and opioid\u2010enriched reports with high\u2010acuity markers. In VigiBase, disproportionality analyses identified a reporting signal for disturbances in consciousness with clindamycin relative to cefazolin in surgical settings. Because spontaneous reports lack exposure denominators and are susceptible to residual confounding, these findings are hypothesis\u2010generating and do not estimate incidence or comparative risk. Evaluation in data sources with denominators and prospective clinical characterization is warranted.<\/jats:p>","DOI":"10.1111\/cts.70534","type":"journal-article","created":{"date-parts":[[2026,4,11]],"date-time":"2026-04-11T03:25:13Z","timestamp":1775877913000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Consciousness Disturbances Reported With Clindamycin Versus Cefazolin in Surgical Patients: A Global Pharmacovigilance Analysis Using\n                    <scp>VigiBase<\/scp>"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0367-8557","authenticated-orcid":false,"given":"Kazuki","family":"Nishida","sequence":"first","affiliation":[{"name":"Department of Biostatistics, School of Public Health Kyoto University  Kyoto Japan"},{"name":"Department of Biostatistics Nagoya University Graduate School of Medicine  Nagoya Aichi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7483-2489","authenticated-orcid":false,"given":"Basile","family":"Chr\u00e9tien","sequence":"additional","affiliation":[{"name":"International Medical Education Department Nagoya University Graduate School of Medicine  Nagoya Aichi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0299-040X","authenticated-orcid":false,"given":"Hiroshi","family":"Morioka","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases Nagoya University Hospital  Nagoya Aichi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-0877-7738","authenticated-orcid":false,"given":"Daigo","family":"Tamakoshi","sequence":"additional","affiliation":[{"name":"Department of Neurology Nagoya University Graduate School of Medicine  Nagoya Aichi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0134-2956","authenticated-orcid":false,"given":"Keita","family":"Hiraga","sequence":"additional","affiliation":[{"name":"Department of Neurology Nagoya University Graduate School of Medicine  Nagoya Aichi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8348-4092","authenticated-orcid":false,"given":"Tomoyuki","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Critical Care Medicine Fujita Health University School of Medicine  Toyoake Aichi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2983-1919","authenticated-orcid":false,"given":"Shigeyuki","family":"Matsui","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, School of Public Health Kyoto University  Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9453-9311","authenticated-orcid":false,"given":"Masahisa","family":"Katsuno","sequence":"additional","affiliation":[{"name":"Department of Neurology Nagoya University Graduate School of Medicine  Nagoya Aichi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7433-4359","authenticated-orcid":false,"given":"Yoshitaka","family":"Hara","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Critical Care Medicine Fujita Health University School of Medicine  Toyoake Aichi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,4,10]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2014.09.020"},{"key":"e_1_2_13_3_1","first-page":"105","volume-title":"Side Effects of Drugs Annual","author":"Shah M. 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