Taking into account the report of the Pharmacovigilance Risk Assessment Committee (PRAC) based on the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing remdesivir, the Committee for Medicinal Products for Human Use (CHMP) reached the following conclusions.
Given the available data from spontaneous reports, including some cases with a close temporal relationship and a positive re-administration and repeat withdrawal (de-challenge) test, PRAC considers a causal relationship between remdesivir and the development of sinus bradycardia to be at least a reasonable possibility.
Since the average age of patients hospitalized with COVID-19 is about 70 years, and many of them have cardiovascular disease or hypertension and often take beta-blockers, which can also cause bradycardia, it is important that physicians are informed of all new risks. Based on this, the package leaflet of medicinal products containing remdesivir should be updated, namely: sinus bradycardia with the frequency "Not known" should be added to the "Adverse reactions" section.
CHMP agrees with the scientific conclusions of PRAC.
CHMP considers that the benefit-risk balance of medicinal products containing remdesivir remains unchanged provided that the instructions for medical use are updated with the relevant information.
List of medicinal products containing remdesivir and authorized for medical use in Ukraine (according to the State Register of Medicinal Products of Ukraine as of 28.09.2021). (11 KB) (Downloaded: 07.10.2021 12:24:18)
For the analysis of the published information, the applicant must use the original text available at the linkhttps://www.ema.europa.eu/en/documents/product-information/veklury-epar-product-information_en.pdf
