Abstract
Background: With the urgent and widespread application of Paxlovid, a novel antiviral drug for Coronavirus Disease 2019 (COVID-19) in clinical practice, concerns regarding its actual efficacy and safety have emerged. In order to provide more evidence to support its clinical application, we sought to perform a descriptive analysis of cases who experienced at least one Paxlovid-related adverse event (AEs) and reported to the FDA Adverse Event Reporting System (FAERS) in the post-marketing period.
Methods: Individual adverse event reports between January 1, 2022 and September 30, 2022, were downloaded from the FAERS website. We completed a descriptive study about the safety of Paxlovid in the treatment of COVID-19. Further, we also analyzed the onset time of Paxlovid-related AEs.
Results: As of 30 September 2022, 16,529 de-duplicated cases were submitted to the FDA, and 5,860 (35.45%) were female. The average age was 58.38 years (S.D. 15.50). Most reports (12,390, 74.96%) were submitted by consumers and 1,436 (8.68%) concerned serious outcomes. The most frequently reported AEs were disease recurrence (7,724, 16.23%), dysgeusia (2,877, 6.05%), and diarrhoea (1,448, 3.04%). The median onset time of Paxlovid-related AEs was 8 days (interquartile range,1-10 days), and most of the cases (2,629, 19.12%) occurred on the day after Paxlovid initiation.
Conclusion: This study indicates that the most common AEs reported with Paxlovid in post-marketing experience are consistent with the safety assessment of antiviral drugs. Even without emerging apparent safety concerns, the incidence of serious outcomes was unexpectedly high, and a few cases of potential new AEs occurred.
[http://dx.doi.org/10.1007/s40257-021-00636-1] [PMID: 34495491]
[http://dx.doi.org/10.1111/imm.13443] [PMID: 34957554]
[http://dx.doi.org/10.1093/femsre/fuac042] [PMID: 36323404]
[http://dx.doi.org/10.3201/eid2704.210016] [PMID: 33522478]
[http://dx.doi.org/10.3389/fimmu.2021.809244] [PMID: 35046961]
[http://dx.doi.org/10.1080/08830185.2022.2079642] [PMID: 35635216]
[http://dx.doi.org/10.1016/j.cell.2022.12.018] [PMID: 36580913]
[http://dx.doi.org/10.1183/13993003.00673-2021] [PMID: 34210790]
[http://dx.doi.org/10.7150/thno.78164] [PMID: 36593971]
[http://dx.doi.org/10.1002/advs.202001435] [PMID: 35403380]
[http://dx.doi.org/10.2147/JBM.S397722] [PMID: 36855559]
[http://dx.doi.org/10.1002/jmv.28592] [PMID: 36806030]
[PMID: 36345404]
[http://dx.doi.org/10.1016/j.biopha.2023.114367] [PMID: 37018987]
[http://dx.doi.org/10.1038/s41392-020-0178-y] [PMID: 32388537]
[http://dx.doi.org/10.3390/v15091970] [PMID: 37766376]
[http://dx.doi.org/10.1097/MD.0000000000020391] [PMID: 32481426]
[http://dx.doi.org/10.1016/j.cmi.2022.04.015] [PMID: 35545195]
[http://dx.doi.org/10.3390/ijms23179866] [PMID: 36077262]
[http://dx.doi.org/10.1016/S2352-3018(19)30336-4] [PMID: 31740348]
[PMID: 37153311]
[http://dx.doi.org/10.3390/vaccines11010107] [PMID: 36679952]
[http://dx.doi.org/10.7759/cureus.35489] [PMID: 36999105]
[http://dx.doi.org/10.1016/j.drup.2021.100794] [PMID: 34991982]
[http://dx.doi.org/10.1016/j.jtocrr.2022.100452] [PMID: 36568522]
[http://dx.doi.org/10.1016/j.taap.2023.116695] [PMID: 37739321]
[http://dx.doi.org/10.1007/s00467-022-05712-0] [PMID: 35982345]
[http://dx.doi.org/10.1007/s13181-022-00922-2] [PMID: 36536192]
[http://dx.doi.org/10.1007/s11095-023-03538-5] [PMID: 37231296]
[http://dx.doi.org/10.1016/j.amjmed.2022.12.017] [PMID: 36608747]
[http://dx.doi.org/10.1001/jama.2023.9925] [PMID: 37285173]
[http://dx.doi.org/10.1056/NEJMoa2118542] [PMID: 35172054]
[http://dx.doi.org/10.1136/bmj.n2713] [PMID: 34750163]
[http://dx.doi.org/10.1038/s41392-022-01249-8] [PMID: 36464706]
[http://dx.doi.org/10.1111/odi.14312] [PMID: 35830268]
[http://dx.doi.org/10.1016/j.jneuroim.2023.578245] [PMID: 37992586]
[http://dx.doi.org/10.1093/cid/ciac180] [PMID: 35245942]
[PMID: 36577095]
[http://dx.doi.org/10.1016/j.cmi.2022.06.029] [PMID: 35792281]
[http://dx.doi.org/10.1101/2022.06.16.22276392]
[http://dx.doi.org/10.1002/jmv.28441] [PMID: 36576379]
[http://dx.doi.org/10.1101/2023.05.30.23290747]
[PMID: 37775486]
[http://dx.doi.org/10.1016/j.therap.2023.03.001] [PMID: 37012153]
[http://dx.doi.org/10.1111/bcp.14868] [PMID: 33871897]
[http://dx.doi.org/10.1002/jmv.28732] [PMID: 37183808]
[http://dx.doi.org/10.1016/j.lanwpc.2023.100694] [PMID: 36777445]
[PMID: 36126225]
[http://dx.doi.org/10.1136/bjophthalmol-2019-313907] [PMID: 31079057]
[http://dx.doi.org/10.1177/1352458520964778] [PMID: 33104449]
[http://dx.doi.org/10.3390/jcm11195731] [PMID: 36233599]
[http://dx.doi.org/10.1007/s10549-020-06029-y] [PMID: 33392835]
[http://dx.doi.org/10.3389/fimmu.2021.758294] [PMID: 34938287]
[http://dx.doi.org/10.1002/jcph.2058] [PMID: 35394079]
[http://dx.doi.org/10.1007/s40265-022-01692-5] [PMID: 35305258]
[http://dx.doi.org/10.1002/jmv.28418] [PMID: 36541710]
[http://dx.doi.org/10.1056/NEJMoa2204919] [PMID: 36001529]
[http://dx.doi.org/10.1093/cid/ciac443] [PMID: 35653428]
[http://dx.doi.org/10.7326/M22-2141] [PMID: 36508742]
[http://dx.doi.org/10.3390/jcm12010034] [PMID: 36614834]
[http://dx.doi.org/10.15585/mmwr.mm7125e2] [PMID: 35737591]
[http://dx.doi.org/10.1101/2022.06.14.22276393]
[http://dx.doi.org/10.1186/s40545-022-00469-1] [PMID: 36274169]
[http://dx.doi.org/10.1002/ohn.278] [PMID: 36821807]
[http://dx.doi.org/10.1016/j.bbrc.2023.10.001] [PMID: 37806252]
[http://dx.doi.org/10.1002/jcla.24880] [PMID: 37088868]
[http://dx.doi.org/10.1002/jmv.29082] [PMID: 37671852]
[http://dx.doi.org/10.1308/rcsann.2021.0012] [PMID: 34767472]
[http://dx.doi.org/10.1007/s40121-022-00729-2] [PMID: 36441485]
[http://dx.doi.org/10.1016/j.ajem.2022.01.028] [PMID: 35121478]
[http://dx.doi.org/10.1002/art.42062] [PMID: 35118829]
[PMID: 35171899]
[http://dx.doi.org/10.1038/s41398-021-01636-9] [PMID: 34615850]
[http://dx.doi.org/10.1016/j.ijmedinf.2022.104950] [PMID: 36508752]