Evidence map›Paper›PMID 38415446›Full record

ArticleCurrent pharmaceutical design2024

Safety Profile of Paxlovid in the Treatment of COVID-19.

Bing Lv, Xin Gao, Guoqiang Zeng, Hui Guo, Faping Li

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Article in Current pharmaceutical design, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Bing LvDepartment of Emergency, The First Hospital of Jilin University, Changchun 130021, Jilin Province, China.
Xin GaoDepartment of Urology, The First Hospital of Jilin University, Changchun 130021, Jilin Province, China.
Guoqiang ZengDepartment of Urology, The First Hospital of Jilin University, Changchun 130021, Jilin Province, China.
Hui GuoDepartment of Urology, The First Hospital of Jilin University, Changchun 130021, Jilin Province, China.
Faping LiDepartment of Urology, The First Hospital of Jilin University, Changchun 130021, Jilin Province, China.ORCID 0000-0003-3016-5159

Funding

Natural Science Foundation of China 52203166
6 · The paper itself

Abstract

backgroundWith 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.

methodsIndividual 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.

resultsAs 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.

conclusionThis 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.

Indexed as

Antiviral AgentsCOVID-19 Drug TreatmentAdultAdverse Drug Reaction Reporting SystemsAgedCOVID-19FemaleHumansMaleMiddle AgedSARS-CoV-2United StatesUnited States Food and Drug AdministrationAntiviral Agentsadverse eventsantiviral drugCOVID-19diarrhea.FAERSPaxlovid

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.