Anika Singh1, Ashwin Kamath1. 1. Department of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal India.
Abstract
BACKGROUND: Remdesivir has been used for treating patients with moderate to severe coronavirus disease 2019 (COVID-19) although there is conflicting evidence regarding its usefulness. Data regarding its safety largely come from the clinical trials conducted to support its emergency use authorization (EUA). This study aimed to identify the adverse events of remdesivir with disproportionately high reporting using real-world data. RESEARCH DESIGN AND METHODS: The adverse event reports submitted to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) by healthcare professionals for drugs that have received EUA or approved for the treatment of COVID-19 in the US were studied. A disproportionality analysis was performed to determine adverse events more frequently reported with remdesivir compared with other COVID-19 drugs in the database. RESULTS: Elevated liver enzymes, acute kidney injury, raised blood creatinine levels, bradycardia, cardiac arrest, and death had disproportionately higher reporting with remdesivir as a suspect drug compared with other drugs. There is no significant difference in the reporting of these events based on patient sex or age. CONCLUSIONS: Our study confirms the drug label information regarding liver enzyme elevation. The renal and cardiac safety signals identified necessitate reevaluation for potential drug-labeling changes.
BACKGROUND:Remdesivir has been used for treating patients with moderate to severe coronavirus disease 2019 (COVID-19) although there is conflicting evidence regarding its usefulness. Data regarding its safety largely come from the clinical trials conducted to support its emergency use authorization (EUA). This study aimed to identify the adverse events of remdesivir with disproportionately high reporting using real-world data. RESEARCH DESIGN AND METHODS: The adverse event reports submitted to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) by healthcare professionals for drugs that have received EUA or approved for the treatment of COVID-19 in the US were studied. A disproportionality analysis was performed to determine adverse events more frequently reported with remdesivir compared with other COVID-19 drugs in the database. RESULTS: Elevated liver enzymes, acute kidney injury, raised blood creatinine levels, bradycardia, cardiac arrest, and death had disproportionately higher reporting with remdesivir as a suspect drug compared with other drugs. There is no significant difference in the reporting of these events based on patient sex or age. CONCLUSIONS: Our study confirms the drug label information regarding liver enzyme elevation. The renal and cardiac safety signals identified necessitate reevaluation for potential drug-labeling changes.
Authors: Carlos K H Wong; Ivan C H Au; Wing Yiu Cheng; Kenneth K C Man; Kristy T K Lau; Lung Yi Mak; Sing Leung Lui; Matthew S H Chung; Xi Xiong; Eric H Y Lau; Benjamin J Cowling Journal: Aliment Pharmacol Ther Date: 2022-03-22 Impact factor: 9.524