Following a safety review, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended adding sinus bradycardia to the product label for remdesivir (Veklury) as an adverse reaction of “unknown frequency.”
At its February meeting, the safety committee announced that it has started a new “safety signal” procedure for remdesivir after the Italian Medicines Agency, AIFA, raised a signal regarding 11 cases of sinus bradycardia in patients taking the antiviral medication use to treat COVID-19, as reported by Medscape Medical News.
As part of its review, the committee examined all the available data on “rare” reported cases of bradycardia in patients who received the drug, as well as data 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 recommended a change in the product information to raise awareness among healthcare professionals about the potential risk of sinus bradycardia in patients taking remdesivir.
The PRAC also noted that the majority of events of sinus bradycardia resolved a few days after the treatment with remdesivir was stopped.