{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T08:38:06Z","timestamp":1789202286229,"version":"build-2803163510"},"reference-count":47,"publisher":"American Medical Association (AMA)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"<jats:sec id=\"ab-zoi221590-4\"><jats:title>Importance<\/jats:title><jats:p>The rapid spread and mortality associated with COVID-19 emphasized a need for surveillance system development to identify adverse events (AEs) to emerging therapeutics. Bradycardia is a remdesivir infusion\u2013associated AE listed in the US Food and Drug Administration\u2013approved prescribing information.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi221590-5\"><jats:title>Objective<\/jats:title><jats:p>To evaluate the magnitude and duration of bradycardic events following remdesivir administration.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi221590-6\"><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>A multicenter cohort study of patients with recorded heart rate less than 60 beats per minute within 24 hours after administration of a remdesivir dose was conducted between November 23, 2020, and October 31, 2021. Participants included patients hospitalized with COVID-19 at 15 medical centers across the US. Patients excluded had AEs unrelated to bradycardia, AEs in addition to bradycardia, or first onset of bradycardia after 5 remdesivir doses.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi221590-7\"><jats:title>Exposures<\/jats:title><jats:p>Remdesivir administration.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi221590-8\"><jats:title>Main Outcomes and Measures<\/jats:title><jats:p>Linear mixed-effect models for the minimum HR before starting remdesivir and within 24 hours of each dose included doses as fixed effects. Baseline covariates were age (\u226565 years vs &amp;amp;lt;65 years), sex (male vs female), cardiovascular disease history (yes vs no), and concomitant use of bradycardia-associated medications. The interactions between variables and doses were considered fixed-effects covariates to adjust models.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi221590-9\"><jats:title>Results<\/jats:title><jats:p>A total of 188 patients were included in the primary analysis and 181 in the secondary analysis. The cohort included 108 men (57.4%); 75 individuals (39.9%) were non-Hispanic White and mean (SD) age was 61.3 (15.4) years. Minimum HR after doses 1 to 5 was lower than before remdesivir. Mean minimum HR was lowest after dose 4, decreasing by \u221215.2 beats per minute (95% CI, \u221217.4 to \u221213.1; <jats:italic>P<\/jats:italic>\u2009&amp;amp;lt;\u2009.001) compared with before remdesivir administration. Mean (SD) minimum HR was 55.6 (10.2) beats per minute across all 5 doses. Of 181 patients included in time-to-event analysis, 91 had their first episode of bradycardia within 23.4 hours (95% CI, 20.1-31.5 hours) and 91 had their lowest HR within 60.7 hours (95% CI, 54.0-68.3 hours). Median time to first bradycardia after starting remdesivir was shorter for patients aged 65 years or older vs those younger than 65 years (18.7 hours; 95% CI, 16.8-23.7 hours vs 31.5 hours; 95% CI, 22.7-39.3 hours; <jats:italic>P<\/jats:italic>\u2009=\u2009.04). Median time to lowest HR was shorter for men vs women (54.2 hours; 95% CI, 47.3-62.0 hours vs 71.0 hours; 95% CI, 59.5-79.6 hours; <jats:italic>P<\/jats:italic>\u2009=\u2009.02).<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi221590-10\"><jats:title>Conclusions and Relevance<\/jats:title><jats:p>In this cohort study, bradycardia occurred during remdesivir infusion and persisted. Given the widespread use of remdesivir, practitioners should be aware of this safety signal.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2022.55815","type":"journal-article","created":{"date-parts":[[2023,2,14]],"date-time":"2023-02-14T16:01:15Z","timestamp":1676390475000},"page":"e2255815","source":"Crossref","is-referenced-by-count":21,"title":["Identification of Bradycardia Following Remdesivir Administration Through the US Food and Drug Administration American College of Medical Toxicology COVID-19 Toxic Pharmacovigilance Project"],"prefix":"10.1001","volume":"6","author":[{"given":"Jason M.","family":"Devgun","sequence":"first","affiliation":[{"name":"Department of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rongmei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, 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