Adverse Events of SARS-CoV-2 Therapy: A Pharmacovigilance Study of the FAERS Database

Viraaj Pannu; Ndausung Udongwo; Steven Imburgio; Anmol Johal; Anton Mararenko; Helen Pozdniakova; Tasnuva Amin; Swapnil Patel; Mohammad Hossain; Arman Mushtaq; Edward Liu; Jose M. Fune; Joseph Heaton

doi:10.1177/10600280231169256

Adverse Events of SARS-CoV-2 Therapy: A Pharmacovigilance Study of the FAERS Database

Viraaj Pannu, Ndausung Udongwo, Steven Imburgio, Anmol Johal, Anton Mararenko, Helen Pozdniakova, Tasnuva Amin, Swapnil Patel, Mohammad Hossain, Arman Mushtaq, Edward Liu, Jose M. Fune, Joseph Heaton

School of Medicine

Hackensack Meridian School of Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

Background: Over the past 2 years of the several strategies recommended to help fight COVID-19, nirmatrelvir/ritonavir is a novel drug shown in the EPIC-HR phase 2 to 3 clinical trial to lower COVID-19-related death or hospitalization at day 28 when compared with placebo. Objective: Our study’s aim was to explore the reported adverse events (AEs) associated with nirmatrelvir/ritonavir use for COVID-19. Method: We conducted a retrospective analysis using the FDA Adverse Event Reporting System (FAERS) database for AEs, listing nirmatrelvir/ritonavir as the primary drug between January and June 2022. The primary outcome was the incidence of reported AEs associated with nirmatrelvir/ritonavir. The OpenFDA database was queried using Python 3.10 to collect the AEs and Stata 17 was used to analyze the database. Adverse events were analyzed by associated medication, with “Covid-19” excluded. Results: A total of 8098 reports were identified between January and June 2022. Most reported complaints in the AE system were COVID-19 and disease recurrence. The most common symptomatic AEs were dysgeusia, diarrhea, cough, fatigue, and headache. Event rates significantly rose between April and May. Disease recurrence and dysgeusia were the most commonly reported complaints for the top 8 concomitant drugs identified. Cardiac arrest, tremor, akathisia, and death were reported in 1, 3, 67, and 5 cases, respectively. Conclusions and Relevance: This is the first retrospective study done on reported AEs associated with nirmatrelvir/ritonavir use for COVID-19. COVID-19 and disease recurrence were the most reported AEs. Further monitoring of the FAERS database is warranted to periodically reassess the safety profile of this medication.

Original language	English
Pages (from-to)	105-109
Number of pages	5
Journal	Annals of Pharmacotherapy
Volume	58
Issue number	2
DOIs	https://doi.org/10.1177/10600280231169256
State	Published - Feb 2024

ASJC Scopus subject areas

Pharmacology (medical)

Keywords

COVID-19
FAERS
adverse events
antivirals
nirmatrelvir/ritonavir

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1177/10600280231169256

Cite this

@article{e9be418fd279477ca6302940c111ec9a,

title = "Adverse Events of SARS-CoV-2 Therapy: A Pharmacovigilance Study of the FAERS Database",

abstract = "Background: Over the past 2 years of the several strategies recommended to help fight COVID-19, nirmatrelvir/ritonavir is a novel drug shown in the EPIC-HR phase 2 to 3 clinical trial to lower COVID-19-related death or hospitalization at day 28 when compared with placebo. Objective: Our study{\textquoteright}s aim was to explore the reported adverse events (AEs) associated with nirmatrelvir/ritonavir use for COVID-19. Method: We conducted a retrospective analysis using the FDA Adverse Event Reporting System (FAERS) database for AEs, listing nirmatrelvir/ritonavir as the primary drug between January and June 2022. The primary outcome was the incidence of reported AEs associated with nirmatrelvir/ritonavir. The OpenFDA database was queried using Python 3.10 to collect the AEs and Stata 17 was used to analyze the database. Adverse events were analyzed by associated medication, with “Covid-19” excluded. Results: A total of 8098 reports were identified between January and June 2022. Most reported complaints in the AE system were COVID-19 and disease recurrence. The most common symptomatic AEs were dysgeusia, diarrhea, cough, fatigue, and headache. Event rates significantly rose between April and May. Disease recurrence and dysgeusia were the most commonly reported complaints for the top 8 concomitant drugs identified. Cardiac arrest, tremor, akathisia, and death were reported in 1, 3, 67, and 5 cases, respectively. Conclusions and Relevance: This is the first retrospective study done on reported AEs associated with nirmatrelvir/ritonavir use for COVID-19. COVID-19 and disease recurrence were the most reported AEs. Further monitoring of the FAERS database is warranted to periodically reassess the safety profile of this medication.",

keywords = "COVID-19, FAERS, adverse events, antivirals, nirmatrelvir/ritonavir",

author = "Viraaj Pannu and Ndausung Udongwo and Steven Imburgio and Anmol Johal and Anton Mararenko and Helen Pozdniakova and Tasnuva Amin and Swapnil Patel and Mohammad Hossain and Arman Mushtaq and Edward Liu and Fune, {Jose M.} and Joseph Heaton",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2023.",

year = "2024",

month = feb,

doi = "10.1177/10600280231169256",

language = "English",

volume = "58",

pages = "105--109",

journal = "Annals of Pharmacotherapy",

issn = "1060-0280",

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TY - JOUR

T1 - Adverse Events of SARS-CoV-2 Therapy

T2 - A Pharmacovigilance Study of the FAERS Database

AU - Pannu, Viraaj

AU - Udongwo, Ndausung

AU - Imburgio, Steven

AU - Johal, Anmol

AU - Mararenko, Anton

AU - Pozdniakova, Helen

AU - Amin, Tasnuva

AU - Patel, Swapnil

AU - Hossain, Mohammad

AU - Mushtaq, Arman

AU - Liu, Edward

AU - Fune, Jose M.

AU - Heaton, Joseph

PY - 2024/2

Y1 - 2024/2

N2 - Background: Over the past 2 years of the several strategies recommended to help fight COVID-19, nirmatrelvir/ritonavir is a novel drug shown in the EPIC-HR phase 2 to 3 clinical trial to lower COVID-19-related death or hospitalization at day 28 when compared with placebo. Objective: Our study’s aim was to explore the reported adverse events (AEs) associated with nirmatrelvir/ritonavir use for COVID-19. Method: We conducted a retrospective analysis using the FDA Adverse Event Reporting System (FAERS) database for AEs, listing nirmatrelvir/ritonavir as the primary drug between January and June 2022. The primary outcome was the incidence of reported AEs associated with nirmatrelvir/ritonavir. The OpenFDA database was queried using Python 3.10 to collect the AEs and Stata 17 was used to analyze the database. Adverse events were analyzed by associated medication, with “Covid-19” excluded. Results: A total of 8098 reports were identified between January and June 2022. Most reported complaints in the AE system were COVID-19 and disease recurrence. The most common symptomatic AEs were dysgeusia, diarrhea, cough, fatigue, and headache. Event rates significantly rose between April and May. Disease recurrence and dysgeusia were the most commonly reported complaints for the top 8 concomitant drugs identified. Cardiac arrest, tremor, akathisia, and death were reported in 1, 3, 67, and 5 cases, respectively. Conclusions and Relevance: This is the first retrospective study done on reported AEs associated with nirmatrelvir/ritonavir use for COVID-19. COVID-19 and disease recurrence were the most reported AEs. Further monitoring of the FAERS database is warranted to periodically reassess the safety profile of this medication.

AB - Background: Over the past 2 years of the several strategies recommended to help fight COVID-19, nirmatrelvir/ritonavir is a novel drug shown in the EPIC-HR phase 2 to 3 clinical trial to lower COVID-19-related death or hospitalization at day 28 when compared with placebo. Objective: Our study’s aim was to explore the reported adverse events (AEs) associated with nirmatrelvir/ritonavir use for COVID-19. Method: We conducted a retrospective analysis using the FDA Adverse Event Reporting System (FAERS) database for AEs, listing nirmatrelvir/ritonavir as the primary drug between January and June 2022. The primary outcome was the incidence of reported AEs associated with nirmatrelvir/ritonavir. The OpenFDA database was queried using Python 3.10 to collect the AEs and Stata 17 was used to analyze the database. Adverse events were analyzed by associated medication, with “Covid-19” excluded. Results: A total of 8098 reports were identified between January and June 2022. Most reported complaints in the AE system were COVID-19 and disease recurrence. The most common symptomatic AEs were dysgeusia, diarrhea, cough, fatigue, and headache. Event rates significantly rose between April and May. Disease recurrence and dysgeusia were the most commonly reported complaints for the top 8 concomitant drugs identified. Cardiac arrest, tremor, akathisia, and death were reported in 1, 3, 67, and 5 cases, respectively. Conclusions and Relevance: This is the first retrospective study done on reported AEs associated with nirmatrelvir/ritonavir use for COVID-19. COVID-19 and disease recurrence were the most reported AEs. Further monitoring of the FAERS database is warranted to periodically reassess the safety profile of this medication.

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KW - FAERS

KW - adverse events

KW - antivirals

KW - nirmatrelvir/ritonavir

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U2 - 10.1177/10600280231169256

DO - 10.1177/10600280231169256

M3 - Article

C2 - 37144730

SN - 1060-0280

VL - 58

SP - 105

EP - 109

JO - Annals of Pharmacotherapy

JF - Annals of Pharmacotherapy

IS - 2

ER -

Adverse Events of SARS-CoV-2 Therapy: A Pharmacovigilance Study of the FAERS Database

Abstract

ASJC Scopus subject areas

Keywords

UN SDGs

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