{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T09:49:33Z","timestamp":1747216173947,"version":"3.40.5"},"reference-count":0,"publisher":"IOS Press","isbn-type":[{"type":"print","value":"9781643684567"},{"type":"electronic","value":"9781643684574"}],"license":[{"start":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T00:00:00Z","timestamp":1706140800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,1,25]]},"abstract":"<jats:p>The US FDA has given emergency use authorization to multiple Covid-19 drugs. We conducted disproportionality analysis to detect adverse reaction rates (ADRs) in the US FDA\u2019s Adverse Event Reporting System. We discovered not only severe ADRs but also unique ADRs and effectiveness that might be explained by pharmacokinetics. This shows that real-time safety reviews could be effective methods for comparing the safety and efficacy of fast-track authorized drugs.<\/jats:p>","DOI":"10.3233\/shti231256","type":"book-chapter","created":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T10:30:52Z","timestamp":1706178652000},"source":"Crossref","is-referenced-by-count":0,"title":["Is the Fast Track Safe? A Safety Evaluation of the COVID-19 Drugs with Real-World Data"],"prefix":"10.3233","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"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9150-3732","authenticated-orcid":false,"given":"Jeong-Hwa","family":"Yoon","sequence":"additional","affiliation":[{"name":"Institute of Health Policy and Management, Medical Research Center, Seoul National University, Seoul, Korea"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7593-7020","authenticated-orcid":false,"given":"Kyehwa","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Information Medicine, Asan Medical Center, Seoul, Korea"}]}],"member":"7437","container-title":["Studies in Health Technology and Informatics","MEDINFO 2023 \u2014 The Future Is Accessible"],"original-title":[],"link":[{"URL":"https:\/\/ebooks.iospress.nl\/pdf\/doi\/10.3233\/SHTI231256","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T10:30:54Z","timestamp":1706178654000},"score":1,"resource":{"primary":{"URL":"https:\/\/ebooks.iospress.nl\/doi\/10.3233\/SHTI231256"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,25]]},"ISBN":["9781643684567","9781643684574"],"references-count":0,"URL":"https:\/\/doi.org\/10.3233\/shti231256","relation":{},"ISSN":["0926-9630","1879-8365"],"issn-type":[{"type":"print","value":"0926-9630"},{"type":"electronic","value":"1879-8365"}],"subject":[],"published":{"date-parts":[[2024,1,25]]}}}