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Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration
Yankun Liang1,2, Lin Ma3, Yuting Wang2
1Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China.
Abstract:
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.
Insights
Molnupiravir, used for COVID-19, shows fewer serious adverse events than remdesivir in younger patients. However, elderly patients (65+) require close safety monitoring due to increased risks.
Area of Science:
- Pharmacovigilance
- Drug Safety
- COVID-19 Therapeutics
Background:
- Molnupiravir is an antiviral medication approved for treating Coronavirus Disease 2019 (COVID-19).
- Post-marketing surveillance is crucial for understanding drug safety profiles in real-world settings.
Purpose of the Study:
- To identify and analyze adverse event (AE) signals associated with molnupiravir using the FAERS database.
- To provide data for ongoing post-marketing safety monitoring of molnupiravir.
Main Methods:
- Extracted individual case safety reports (ICSRs) for molnupiravir in COVID-19 patients from the FAERS database.
- Conducted descriptive analysis and disproportionality analyses (ROR method) stratified by age and gender.
Main Results:
- Analyzed 2,285 ICSRs where molnupiravir was the primary suspect drug.
- Higher proportions of molnupiravir ICSRs were reported in individuals aged 65+ (70.07%) and women (54.06%).
- Gastrointestinal and skin disorders were the most frequent AEs; elderly patients showed increased risk for cardiac, hepatobiliary, renal, and vascular disorders.
Conclusions:
- Molnupiravir demonstrated a lower risk of serious adverse events compared to remdesivir in patients under 65.
- Close safety monitoring is essential for elderly patients (65+) using molnupiravir.
- Further research is needed to assess molnupiravir's long-term safety, especially in high-risk populations.
