Following a safety review, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has advocated adding sinus bradycardia into the product label for remdesivir (Veklury) as a negative reaction of”unknown frequency.”
At its February meeting, the safety committee announced that it has established a new”safety signal” process of remdesivir following the Italian Medicines Agency, AIFA, increased a signal concerning 11 cases of sinus bradycardia in patients carrying the antifungal medication usage to deal with COVID-19, as reported by Medscape Medical News.
As a part of its evaluation, the committee examined all of the available data on”rare” reported instances of bradycardia in patients that received the drug, as well as information from clinical trials and the scientific literature.
At its June meeting, the PRAC concluded that a causal relationship between remdesivir and sinus bradycardia is”at least a reasonable possibility.”
Therefore, the committee advocated a change in the