التفاصيل البيبلوغرافية
العنوان: |
Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database |
المؤلفون: |
Silva, Nayara Aparecida de Oliveira, Zara, Ana Laura de Sene Amâncio, Figueras, Albert, Melo, Daniela Oliveira de |
المصدر: |
Cadernos de Saúde Pública. January 2021 37(10) |
بيانات النشر: |
Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz, 2021. |
سنة النشر: |
2021 |
مصطلحات موضوعية: |
Coronavirus Infections, Pharmacovigilance, Adverse Drug Reaction Reporting Systems, Drug-Related Side Effects and Adverse Reactions |
الوصف: |
The U.S. Food and Drug Administration (FDA) has stated that the prescription of remdesivir should be cautious for patients with estimated glomerular filtration rate (eGFR) < 30 and some studies reported risk of adverse renal events. The available information on the renal safety profile for remdesivir is limited, thus we analyzed the renal and urinary adverse reactions attributed to remdesivir reported in a large open pharmacovigilance database. We obtained reports of remdesivir and other drugs used to treat COVID-19 (tocilizumab, hydroxychloroquine, lopinavir/ritonavir) registered by September 30 2020, from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). We analyzed the reporting odds ratios (RORs) for reports of adverse renal and urinary events for remdesivir and other drugs. We found 2,922 reports with remdesivir registered in FAERS for COVID-19. Among these, 493 renal and urinary adverse effects (16.9%) were reported. The most frequent events were acute kidney injury (338; 11.6%), renal impairment (86; 2.9%), and renal failure (53; 1.8%). Versus hydroxychloroquine, lopinavir/ritonavir, or tocilizumab, the use of remdesivir was associated with an increased chance of reporting renal and urinary disorders regardless of gender and age of patients (2.53; 95%CI: 2.10-3.06). The ROR remained significant when we restricted the analysis to hydroxychloroquine (4.31; 95%CI: 3.25-5.71) or tocilizumab (3.92; 95%CI: 2.51-6.12). Our results reinforce this already reported signal, emphasizing that it could be extremely useful for health professionals who prescribe this new antiviral to treat COVID-19, mainly knowing its low efficacy. |
نوع الوثيقة: |
article |
وصف الملف: |
text/html |
اللغة: |
English |
تدمد: |
0102-311X |
DOI: |
10.1590/0102-311x00077721 |
URL الوصول: |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0102-311X2021001005024 |
Rights: |
info:eu-repo/semantics/openAccess |
رقم الانضمام: |
edssci.S0102.311X2021001005024 |
قاعدة البيانات: |
SciELO |