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Assessment of adverse events associated with remdesivir use for coronavirus disease 2019 using real-world data.
Singh, Anika; Kamath, Ashwin.
  • Singh A; Department of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.
  • Kamath A; Department of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Expert Opin Drug Saf ; 20(12): 1559-1564, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1334105
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 health-care professionals for drugs that have received EUA or approved for the treatment of COVID-19 in the US were studied. Adisproportionality 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 asuspect 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Bradycardia / Adenosine Monophosphate / Alanine / Drug-Related Side Effects and Adverse Reactions / Acute Kidney Injury / COVID-19 / COVID-19 Drug Treatment / Liver Function Tests Type of study: Diagnostic study / Observational study / Prognostic study Topics: Long Covid Limits: Female / Humans / Male / Middle aged Country/Region as subject: North America Language: English Journal: Expert Opin Drug Saf Journal subject: Pharmacology / Drug Therapy Year: 2021 Document Type: Article Affiliation country: 14740338.2021.1962846

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Bradycardia / Adenosine Monophosphate / Alanine / Drug-Related Side Effects and Adverse Reactions / Acute Kidney Injury / COVID-19 / COVID-19 Drug Treatment / Liver Function Tests Type of study: Diagnostic study / Observational study / Prognostic study Topics: Long Covid Limits: Female / Humans / Male / Middle aged Country/Region as subject: North America Language: English Journal: Expert Opin Drug Saf Journal subject: Pharmacology / Drug Therapy Year: 2021 Document Type: Article Affiliation country: 14740338.2021.1962846