Kidney problems in COVID-19 Patients are not related to Remdesivir: European Regulator

The European medicines regulator announced on Friday that its Pharmacovigilance Risk Assessment Committee (PRAC) found no evidence that Gilead’s Remdesivir caused kidney problems in certain COVID-19 patients.

Remdesivir, which is sold under the brand name Veklury, was provisionally approved in July by the EU for the treatment of COVID-19 in adults and adolescents with pneumonia who require oxygen support.

The European Medicines Agency (EMA) said that, to reach this conclusion, the PRAC had evaluated data provided by the US drug manufacturer, as well as analyzes of recorded adverse reactions, trial data and published papers. on COVID-19 patients with acute kidney injury.

On the other hand, the PRAC also said that it was not yet clear if there is any connection between remdesivir and reports of sinus bradycardia (characterized by a slow heart rate) in patients with COVID-19, so it started a new study on the matter.

The PRAC had started an in-depth evaluation of all available data after the Italian regulator raised concerns about 11 cases of sinus bradycardia in patients who had been treated with remdesivir, according to the AEM.

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