1. Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database
- Author
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Marine Muzzone, Vincent L.M. Esnault, Audrey Fresse, Fanny Rocher, Audrey Laurain, Milou-Daniel Drici, Nadège Parassol, and Alexandre Gérard
- Subjects
World Health Organization ,computer.software_genre ,Antiviral Agents ,030226 pharmacology & pharmacy ,Pharmacovigilance ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Tocilizumab ,Odds Ratio ,Humans ,Medicine ,Pharmacology (medical) ,Summary of Product Characteristics ,Pharmacology ,Alanine ,Database ,SARS-CoV-2 ,business.industry ,Hydroxychloroquine ,Lopinavir ,Odds ratio ,Acute Kidney Injury ,Adenosine Monophosphate ,Confidence interval ,COVID-19 Drug Treatment ,Clinical trial ,chemistry ,030220 oncology & carcinogenesis ,business ,computer ,medicine.drug - Abstract
Remdesivir is approved for emergency use by the US Food and Drug Administration (FDA) and authorized conditionally by the European Medicines Agency (EMA) for patients with coronavirus disease 2019 (COVID-19). Its benefit-risk ratio is still being explored because data in the field are rather scant. A decrease of the creatinine clearance associated with remdesivir has been inconstantly reported in clinical trials with unclear relevance. Despite these uncertainties, we searched for a potential signal of acute renal failure (ARF) in pharmacovigilance postmarketing data. An analysis of the international pharmacovigilance postmarketing databases (VigiBase) of the World Health Organization (WHO) was performed, using two disproportionality methods. Reporting odds ratio (ROR) compared the number of ARF cases reported with remdesivir, with those reported with other drugs prescribed in comparable situations of COVID-19 (hydroxychloroquine, tocilizumab, and lopinavir/ritonavir). The combination of the terms "acute renal failure" and "remdesivir" yielded a statistically significant disproportionality signal with 138 observed cases instead of the 9 expected. ROR of ARF with remdesivir was 20-fold (20.3; confidence interval 0.95 [15.7-26.3], P
- Published
- 2021
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