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Safety Monitoring of Oral Antiviral COVID-19 Treatment Using Korea Adverse Event Reporting System (KAERS) Database

Choe et al., Pharmacoepidemiology and Risk Management, doi:10.56142/perm.24.0006
Mar 2024  
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Safety analysis of paxlovid and molnupiravir. Disproportionality analysis found significant signals for paxlovid with sensory abnormalities, interactions, fecal abnormalities, and signals not on the label including olfactory nerve disorders, appetite disorders, hallucinations and urinary adverse events. For molnupiravir, significant signals were found for cardiovascular adverse events not on the label like heart rate and vascular tests.
Concerns have been raised that the mutagenic mechanism of action may create dangerous variants or cause cancer1-9. Multiple analyses have identified variants potentially created by molnupiravir10-13.
Study covers paxlovid and molnupiravir.
Choe et al., 31 Mar 2024, peer-reviewed, 7 authors.
This PaperMolnupiravirAll
Safety Monitoring of Oral Antiviral COVID-19 Treatment Using Korea Adverse Event Reporting System (KAERS) Database
Ju-Young Shin, Yunju Choe, Se Jung Park, Ju Hwan Kim, Dongwon Yoon, Dong Yoon Kang, Jae Hoon, 항바이러스제 약물감시, 연구 최윤주, 박세정, 성균관대학교 바이오헬스규제과학과, 성균관대학교 약학과, 울산대학교 의과대학, 울산대학교병원 예방의학과, 가천대학교 예방의학과, 성균관대학교 임상연구설계평가학과
Objective: This study aimed to evaluate the association between nirmatrelvir/ritonavir, molnupiravir and adverse events and identify safety signals not previously known. Methods: To identify major adverse events and safety signals associated with nirmatrelvir/ritonavir and molnupiravir, we conducted pharmacovigilance study using drug-related adverse events reported to KIDS KAERS DB (2305A0011). Disproportionality analysis were performed using reporting odds ratio (ROR) and information component (IC) method to detected new safety signals not listed in drug label. Results: Adverse events related to nirmatrelvir/ritonavir and molnupiravir were frequently reported in women and person aged ≥ 65, and mostly reported as not serious. Following nirmatrelvir/ritonavir administration, 'sensory abnormalities' (20.18%), 'diarrhoea' (13.76%), and 'nausea and vomiting symptoms' (9.87%) were most commonly reported, while for molnupiravir, 'nausea and vomiting symptoms' (15.92%), 'neurological signs and symptoms' (15.92%), 'urticarias' (10.45%) were predominantly reported. Disproportionality analysis revealed a significant association of nirmatrelvir/ritonavir with 'sensory abnormalities' (ROR [95% CI] = 223.74 [207.24-241.55]), 'interactions' (ROR [95% CI] = 37. 35 [15.10-92.35]), 'faecal abnormalities' (ROR [95% CI] = 32. 33 [18.68-56.36]). Adverse events not listed on drug label included 'olfactory nerve disorders', 'appitite disorder', 'hallucinations' and urinary adverse events. For molnupiravir, strong association were observed with cardiovascular adverse events such as 'heart rate and pulse investigations' (ROR [95% CI] = 58. 60 [18.96-181.16]) and 'vascular tests' (ROR [95% CI] = 10.97 [4.09-29.47]), which were not included in drug label. Conclusion: Adverse events following the use of nirmatrelvir/ritonavir and molnupiravir were generally not serious, but some safety signals not listed on drug label were newly detected and warranted attention. We expected this study to provide basic data of safety for oral antivirals of COVID-19 and may contribute to the development of future drug safety guidelines. (PeRM 2024;16:65-78)
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