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Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system

Molnupiravir, an urgently approved drug during the Coronavirus Disease 2019 (COVID-19) pandemic, serves as the basis for our study, which relies on the Food and Drug Administration Adverse Event Reporting System (FAERS). The objective is to extract adverse event (AE) signals associated with molnupir...

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Autores principales: Liang, Yankun, Ma, Lin, Wang, Yuting, Zheng, Jingping, Su, Ling, Lyu, Jun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10644225/
https://www.ncbi.nlm.nih.gov/pubmed/38026949
http://dx.doi.org/10.3389/fphar.2023.1253799
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author Liang, Yankun
Ma, Lin
Wang, Yuting
Zheng, Jingping
Su, Ling
Lyu, Jun
author_facet Liang, Yankun
Ma, Lin
Wang, Yuting
Zheng, Jingping
Su, Ling
Lyu, Jun
author_sort Liang, Yankun
collection PubMed
description Molnupiravir, an urgently approved drug during the Coronavirus Disease 2019 (COVID-19) pandemic, serves as the basis for our study, which relies on the Food and Drug Administration Adverse Event Reporting System (FAERS). The objective is to extract adverse event (AE) signals associated with molnupiravir from the FAERS database, thereby providing a reference for post-marketing monitoring of adverse events. Specifically, we extracted individual case safety reports (ICSRs) from the database, focusing on cases with COVID-19 indications and molnupiravir identified as the primary suspect drug. Descriptive analysis of the extracted data was performed, followed by four disproportionality analyses using the reporting odds ratio (ROR) method. These analyses were conducted across four levels, encompassing overall data, reports by health professionals, as well as age and gender differentiations, ensuring the robustness of the analysis results. In total, 116,576 ICSRs with COVID-19 indications and 2,285 ICSRs with molnupiravir as the primary suspect were extracted. Notably, after excluding cases with unknown age or gender, a higher proportion of molnupiravir-related ICSRs were observed among individuals aged 65 years and older (70.07%) and women (54.06%). The most frequently reported adverse events and AE signals were associated with gastrointestinal disorders, as well as skin and subcutaneous tissue disorders. Moreover, individuals aged 65 years and older exhibited a higher risk of cardiac disorders, hepatobiliary disorders, renal and urinary disorders, and vascular disorders. In conclusion, this study found molnupiravir demonstrated a lower risk of serious adverse events compared to other RNA antiviral drugs like remdesivir in patients under 65 years old. However, close monitoring of its safety is still necessary for elderly patients aged 65 years and above. Further studies are warranted to continuously assess the safety profile of molnupiravir as its usage increases, especially in high risk populations.
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spelling pubmed-106442252023-10-31 Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system Liang, Yankun Ma, Lin Wang, Yuting Zheng, Jingping Su, Ling Lyu, Jun Front Pharmacol Pharmacology Molnupiravir, an urgently approved drug during the Coronavirus Disease 2019 (COVID-19) pandemic, serves as the basis for our study, which relies on the Food and Drug Administration Adverse Event Reporting System (FAERS). The objective is to extract adverse event (AE) signals associated with molnupiravir from the FAERS database, thereby providing a reference for post-marketing monitoring of adverse events. Specifically, we extracted individual case safety reports (ICSRs) from the database, focusing on cases with COVID-19 indications and molnupiravir identified as the primary suspect drug. Descriptive analysis of the extracted data was performed, followed by four disproportionality analyses using the reporting odds ratio (ROR) method. These analyses were conducted across four levels, encompassing overall data, reports by health professionals, as well as age and gender differentiations, ensuring the robustness of the analysis results. In total, 116,576 ICSRs with COVID-19 indications and 2,285 ICSRs with molnupiravir as the primary suspect were extracted. Notably, after excluding cases with unknown age or gender, a higher proportion of molnupiravir-related ICSRs were observed among individuals aged 65 years and older (70.07%) and women (54.06%). The most frequently reported adverse events and AE signals were associated with gastrointestinal disorders, as well as skin and subcutaneous tissue disorders. Moreover, individuals aged 65 years and older exhibited a higher risk of cardiac disorders, hepatobiliary disorders, renal and urinary disorders, and vascular disorders. In conclusion, this study found molnupiravir demonstrated a lower risk of serious adverse events compared to other RNA antiviral drugs like remdesivir in patients under 65 years old. However, close monitoring of its safety is still necessary for elderly patients aged 65 years and above. Further studies are warranted to continuously assess the safety profile of molnupiravir as its usage increases, especially in high risk populations. Frontiers Media S.A. 2023-10-31 /pmc/articles/PMC10644225/ /pubmed/38026949 http://dx.doi.org/10.3389/fphar.2023.1253799 Text en Copyright © 2023 Liang, Ma, Wang, Zheng, Su and Lyu. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Liang, Yankun
Ma, Lin
Wang, Yuting
Zheng, Jingping
Su, Ling
Lyu, Jun
Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system
title Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system
title_full Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system
title_fullStr Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system
title_full_unstemmed Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system
title_short Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system
title_sort adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10644225/
https://www.ncbi.nlm.nih.gov/pubmed/38026949
http://dx.doi.org/10.3389/fphar.2023.1253799
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