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Remdesivir for COVID-19 and acute kidney injury: disproportionality analysis of data from the U.S. Food and Drug Administration Adverse Event Reporting System.
Li, Xiaotong; Zhou, Liyuan; Gaggl, Martina; Kinlaw, Alan C; Gou, Zhuoyue; Xu, Yang; Wei, Jingkai; Wang, Tiansheng.
  • Li X; School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA.
  • Zhou L; Institute for Drug Evaluation, Peking University Health Science Center, Beijing, China.
  • Gaggl M; Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
  • Kinlaw AC; Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria.
  • Gou Z; Division of Pharmaceutical Outcomes and Policy, University of North Carolina School of Pharmacy, Chapel Hill, NC, USA.
  • Xu Y; Institute for Drug Evaluation, Peking University Health Science Center, Beijing, China.
  • Wei J; Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.
  • Wang T; Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.
Int J Clin Pharm ; 45(2): 509-514, 2023 Apr.
Article in English | MEDLINE | ID: covidwho-2268881
ABSTRACT

BACKGROUND:

Evidence about remdesivir-associated acute kidney injury (AKI) among patients with novel coronavirus disease 2019 (COVID-19) was controversial.

AIM:

To investigate the signal of disproportionate reporting of remdesivir-related AKI in COVID-19 patients over time with data from US Food and Drug Administration Adverse Event Reporting System.

METHOD:

Adverse events in COVID-19 patients reported between April 2020 and September 2022 were included. Reporting odds ratios (RORs) of AKI and renal disorders (a more sensitive definition for AKI) were estimated to compare remdesivir with other medications prescribed in comparable situations of COVID-19.

RESULTS:

During the entire study period, significant signals were identified for remdesivir-related AKI (ROR 2.00, 95% CI 1.83-2.18) and renal disorder (ROR 2.35, 95% CI 2.17-2.54) when compared to all comparable drugs. However, in the third quarter of 2022 (the most recent quarter) signals disappeared as the ROR of AKI was 1.50 (95% CI 0.91-2.45) and ROR of renal disorder was 1.69 (95% CI 1.06-2.70). Number of signals in sensitivity analyses and the proportion of AKI in remdesivir-associated events decreased over time.

CONCLUSION:

In COVID-19 patients, we observed diminishing signals of remdesivir-associated AKI over time and no significant signal in the most recent quarter, suggesting remdesivir might not be nephrotoxic.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Drug-Related Side Effects and Adverse Reactions / Acute Kidney Injury / COVID-19 Type of study: Observational study / Prognostic study Limits: Humans Country/Region as subject: North America Language: English Journal: Int J Clin Pharm Year: 2023 Document Type: Article Affiliation country: S11096-023-01554-4

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Drug-Related Side Effects and Adverse Reactions / Acute Kidney Injury / COVID-19 Type of study: Observational study / Prognostic study Limits: Humans Country/Region as subject: North America Language: English Journal: Int J Clin Pharm Year: 2023 Document Type: Article Affiliation country: S11096-023-01554-4