Remdesivir-related acute kidney injury in patients with COVID-19
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Remdesivir-related acute kidney injury in patients with COVID-19 The European Medicines Agency (EMA) has announced that its Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing a safety signal after reports of acute kidney injury (AKI) in patients receiving remdesivir [Veklury] for the treatment of COVID-19. Remdesivir was granted conditional marketing authorisation in the EU for the treatment of COVID-19 in severely ill patients 12 years of age and over who have pneumonia and require supplemental oxygen. More evidence on the benefits and safety of remdesivir in these patients is required to be submitted in the post-authorisation phase. Enhanced safety monitoring is being conducted to identify adverse reactions in remdesivir-treated patients, and AKI is being monitored as an adverse event of special interest in monthly summary safety reports. Product information for remdesivir currently advises doctors to monitor patients for renal impairment before and during treatment, and advises that the drug should not be initiated in patients with decreased renal function. A causal relationship between remdesivir and AKI has not yet been determined, but if a causal relationship is confirmed or considered likely, regulatory action may be necessary and the summary of product characteristics and the package leaflet will be updated. The EMA will communicate further on this issue after the PRAC’s review has been completed. EMA. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October 2020. Internet Document : 2 Oct 2020. Available from: 803507713 URL: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-september-1-october-2020
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Reactions 17 Oct 2020 No. 1826
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