{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T15:44:10Z","timestamp":1787067850392,"version":"build-2736575974"},"reference-count":55,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2024,11,12]],"date-time":"2024-11-12T00:00:00Z","timestamp":1731369600000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003625","name":"Ministry of Health and Welfare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003625","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002701","name":"Ministry of Education","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002701","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The US Food and Drug Administration (US FDA) granted emergency use authorization (EUA) for multiple coronavirus disease 2019 (COVID\u201019) drugs as a medical countermeasure during the COVID\u201019 pandemic. Despite these drugs' fast\u2010track nature, concerns persist regarding their efficacy and potential adverse effects. Thus, the continuous surveillance and understanding of these drugs' safety profiles are crucial in such scenarios.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Using the FDA Adverse Event Reporting System (FAERS) database, we aimed to compare the adverse drug reactions (ADRs) of four fast\u2010track COVID\u201019 drugs to explore the potential of real\u2010world data for providing prompt feedback in clinical settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>To evaluate the post\u2010marketing safety of fast\u2010track COVID\u201019 drugs, we descriptively evaluated the ADRs of four COVID\u201019 drugs (bebtelovimab, molnupiravir, nirmatrelvir\/ritonavir, and remdesivir) using FAERS data reported from January 2020 to June 2022. We examined FAERS case records of COVID\u201019 drugs reported as the \u201cprimary suspect drug\u201d as a case group and the records of other drugs as the control. \u201cSerious adverse drug reactions (SADRs)\u201d were defined based on FDA guidelines. Using reporting odds ratios, disproportionality analysis was conducted to determine significant signals for ADRs related to each of the four drugs compared with those of others, both at the preferred term (PT) and system organ class (SOC) levels. To explore the occurrence of reporting each serious outcome reported to the four drugs, we fitted logistic regression models, adjusting for age and sex.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>During the study period, 5\u2009248\u2009221 cases were submitted to FAERS, including 17\u2009275 cases of the four COVID\u201019 drugs: bebtelovimab (532 cases), molnupiravir (1106 cases), nirmatrelvir\/ritonavir (9217 cases), and remdesivir (6420 cases). A total of 64, 46, 116, and 207 PTs with significant disproportionality were identified for each drug, respectively. \u201cInfusion\u2010related reaction\u201d (18.4%), \u201cdiarrhea\u201d (7.4%), \u201cdysgeusia\u201d (11.4%), and \u201cincreased alanine aminotransferase\u201d (14.5%) were the most frequently reported SADRs for bebtelovimab, molnupiravir, nirmatrelvir\/ritonavir, and remdesivir, respectively. Among the 27 SOCs, statistically significant signals were observed in 10, 3, 0, and 8 SOCs for bebtelovimab, molnupiravir, nirmatrelvir\/ritonavir, and remdesivir, respectively. Remdesivir showed a higher occurrence for the reporting of death or life\u2010threatening ADRs compared with the control (adjusted odds ratio (OR)\u2009=\u20092.44, 95% confidence interval (CI)\u2009=\u20092.23\u20132.59; adjusted OR\u2009=\u20091.82, 95% CI\u2009=\u20091.64\u20132.02, respectively).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>We identified potential ADRs associated with COVID\u201019 drugs and provided insights into their real\u2010world safety. This study demonstrated that real\u2010world data and real\u2010time safety reviews could be effective methods for the timely detection of ADR signals of drugs that have received fast\u2010track approval, as exemplified by COVID\u201019 drugs. These findings underscore the importance of the continued surveillance, efficient data processing, and establishment of automated pipelines for real\u2010time safety reviews.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70043","type":"journal-article","created":{"date-parts":[[2024,11,13]],"date-time":"2024-11-13T07:25:18Z","timestamp":1731482718000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Investigating the Safety Profile of Fast\u2010Track\n                    <scp>COVID<\/scp>\n                    \u201019 Drugs Using the\n                    <scp>FDA<\/scp>\n                    Adverse Event Reporting System Database: A Comparative Observational Study"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9555-0926","authenticated-orcid":false,"given":"Hyo Jung","family":"Kim","sequence":"first","affiliation":[{"name":"Department of Digital Health, Samsung Advanced Institute for Health Science and Technology Sungkyunkwan University  Seoul Korea"},{"name":"Center of Research Resource Standardization Research Institution for Future Medicine, Samsung Medical Center  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9150-3732","authenticated-orcid":false,"given":"Jeong\u2010Hwa","family":"Yoon","sequence":"additional","affiliation":[{"name":"Medical Big Data Research Center, Medical Research Center Seoul National University  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7593-7020","authenticated-orcid":false,"given":"Kye Hwa","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Information Medicine, Asan Medical Center  Seoul Korea"},{"name":"Department of Digital Medicine Ulsan University College of Medicine  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,11,12]]},"reference":[{"key":"e_1_2_14_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp2118468"},{"key":"e_1_2_14_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40290\u2010021\u201000397\u20106"},{"key":"e_1_2_14_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2021.7257"},{"key":"e_1_2_14_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2020.2402"},{"key":"e_1_2_14_6_1","unstructured":"U.S. Food and Drug Administration \u201cFDA Announces Bebtelovimab is Not Currently Authorized in Any US Region \u201d(2020) accessed March 16 2023 https:\/\/www.fda.gov\/drugs\/drug\u2010safety\u2010and\u2010availability\/fda\u2010announces\u2010bebtelovimab\u2010not\u2010currently\u2010authorized\u2010any\u2010us\u2010region."},{"key":"e_1_2_14_7_1","unstructured":"US Food and Drug Administration \u201cRequest for Emergency Use Authorization for Use of Chloroquine Phosphate or Hydroxychloroquine Sulfate Supplied From the Strategic National Stockpile for Treatment of 2019 Coronavirus Disease \u201d(2020) accessed July 23 2022 https:\/\/www.fda.gov\/media\/136534\/download."},{"key":"e_1_2_14_8_1","doi-asserted-by":"publisher","DOI":"10.7573\/dic.2020-4-14"},{"key":"e_1_2_14_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473\u20103099(20)30200\u20100"},{"key":"e_1_2_14_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2007016"},{"key":"e_1_2_14_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(20)31022\u20109"},{"issue":"23","key":"e_1_2_14_12_1","first-page":"2365","article-title":"Emergency Use Authorization of Remdesivir: The Need for a Transparent Distribution Process","volume":"323","author":"Ison M. 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