6ER-042 Reported drug induced acute kidney injury: a pharmacovigilance analysis

<h3>Background and Importance</h3> Acute Kidney Injury (AKI) is a condition that may result from various factors, including the exposure to nephrotoxic drugs, which can lead to hospital admission but can also occur during hospitalisation, extending its duration. The incidence of AKI among hospitalised patients varies, with underdiagnosis rates estimated to exceed 20% in developed countries and approximately 7% in developing countries. <h3>Aim and Objectives</h3> To identify the drugs most frequently reported to the Portuguese Nacional Pharmacovigilance Database associated with AKI in Portugal. <h3>Material and Methods</h3> A case/non-case study was conducted, analysing data pertaining to the period between 2009 and 2020. ‘Acute Renal Failure’ standardised MedDRA query was used to define cases, and a random sample of four matched non-cases was used to estimate the reporting odds ratio (ROR) at the ATC level 2. <h3>Results</h3> Our analysis focused on 53,505 reports, among which less than 1% were AKI cases (n=352). Nonetheless, nearly 10% of these led to death. Most frequently, AKI cases involved ≥2 ‘suspected’ medicines, among 559 medicines classified as ‘suspected’ and 11 considered to be potentially associated with the occurrence of AKI. The therapeutic subgroups with the highest ROR was that of antithrombotic agents (ROR, 6.72; 95% CI: 2.23–20.22), followed by systemic antivirals (ROR, 4.02; 95% CI: 2.76–5.87), and also significant was that of antineoplastic agents (ROR, 2.14; 95% CI: 1.48–3.11). <h3>Conclusion and Relevance</h3> This study underscores the importance of clinical pharmacy activities in closely monitoring the renal function of patients with known risk factors or those prescribed medications known to increase the risk of AKI. <h3>References and/or Acknowledgements</h3> Khadzhynov D, Schmidt D, Hardt J, Rauch G, Gocke P, Eckardt KU, <i>et al</i>. The incidence of acute kidney injury and associated hospital mortality. <i>Dtsch Arztebl Int</i>. 2019;<b>116</b>(22):397–404. Goh CY, Visvanathan R, Leong CT, <i>et al</i>. A prospective study of incidence and outcome of acute kidney injury among hospitalised patients in Malaysia (My-AKI). <i>Med J Malaysia</i>. 2023;<b>78</b>(6):733–42. Chawla LS, Eggers PW, Star RA, <i>et al</i>. Acute kidney injury and chronic kidney disease as interconnected syndromes. <i>N Engl J Med</i>. 2014;<b>371</b>(1):58–66. <h3>Conflict of Interest</h3> No conflict of interest

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Published
2025-03-01
DOI
https://doi.org/10.1136/ejhpharm-2025-eahp.486
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
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article

6ER-042 Reported drug induced acute kidney injury: a pharmacovigilance analysis

F Fernandez-Llimos, F Duarte-Ramos, F Alves Da Costa, C Da Luz Oliveira
Pharmacovigilance and Adverse Drug Reactions
article

6ER-042 Reported drug induced acute kidney injury: a pharmacovigilance analysis

F Fernandez-Llimos, F Duarte-Ramos, F Alves Da Costa, C Da Luz Oliveira
article en

Abstract

<h3>Background and Importance</h3> Acute Kidney Injury (AKI) is a condition that may result from various factors, including the exposure to nephrotoxic drugs, which can lead to hospital admission but can also occur during hospitalisation, extending its duration. The incidence of AKI among hospitalised patients varies, with underdiagnosis rates estimated to exceed 20% in developed countries and approximately 7% in developing countries. <h3>Aim and Objectives</h3> To identify the drugs most frequently reported to the Portuguese Nacional Pharmacovigilance Database associated with AKI in Portugal. <h3>Material and Methods</h3> A case/non-case study was conducted, analysing data pertaining to the period between 2009 and 2020. ‘Acute Renal Failure’ standardised MedDRA query was used to define cases, and a random sample of four matched non-cases was used to estimate the reporting odds ratio (ROR) at the ATC level 2. <h3>Results</h3> Our analysis focused on 53,505 reports, among which less than 1% were AKI cases (n=352). Nonetheless, nearly 10% of these led to death. Most frequently, AKI cases involved ≥2 ‘suspected’ medicines, among 559 medicines classified as ‘suspected’ and 11 considered to be potentially associated with the occurrence of AKI. The therapeutic subgroups with the highest ROR was that of antithrombotic agents (ROR, 6.72; 95% CI: 2.23–20.22), followed by systemic antivirals (ROR, 4.02; 95% CI: 2.76–5.87), and also significant was that of antineoplastic agents (ROR, 2.14; 95% CI: 1.48–3.11). <h3>Conclusion and Relevance</h3> This study underscores the importance of clinical pharmacy activities in closely monitoring the renal function of patients with known risk factors or those prescribed medications known to increase the risk of AKI. <h3>References and/or Acknowledgements</h3> Khadzhynov D, Schmidt D, Hardt J, Rauch G, Gocke P, Eckardt KU, <i>et al</i>. The incidence of acute kidney injury and associated hospital mortality. <i>Dtsch Arztebl Int</i>. 2019;<b>116</b>(22):397–404. Goh CY, Visvanathan R, Leong CT, <i>et al</i>. A prospective study of incidence and outcome of acute kidney injury among hospitalised patients in Malaysia (My-AKI). <i>Med J Malaysia</i>. 2023;<b>78</b>(6):733–42. Chawla LS, Eggers PW, Star RA, <i>et al</i>. Acute kidney injury and chronic kidney disease as interconnected syndromes. <i>N Engl J Med</i>. 2014;<b>371</b>(1):58–66. <h3>Conflict of Interest</h3> No conflict of interest

University of Lisbon (PT), Universidade do Porto (PT), Hospital Vila Franca de Xira (PT)
Good health and well-being
Openalex Percentile: Top 95%
Pharmacovigilance and Adverse Drug Reactions
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