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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
A 52-year-old woman developed sinus bradycardia and deranged liver enzymes during treatment with favipiravir for COVID-19 pneumonia. Additionally, metoclopramide and off label treatment with dexamethasone also contributed to sinus bradycardia [routes and duration of treatments to reaction onsets not stated; not all dosages, indications and outcomes stated].
The woman, who was admitted with fever, cough and dyspnoea, was diagnosed with COVID-19 pneumonia. Subsequently, she received favipiravir at a loading dose of 1600mg twice a day and off-label dexamethasone for COVID-19 pneumonia. She also received metoclopramide [indication not stated]. Immediately, she developed asymptomatic and severe sinus bradycardia with a HR of 30 beats/minute.
The woman's treatment with dexamethasone and metoclopramide was stopped as they were suspected to have caused bradycardia. However, a minimal improvement was noted. She continued favipiravir at a maintenance dose of 600mg twice a day along with dexamethasone. On day 4, favipiravir was stopped due to the side-effect of deranged liver enzymes. Thereafter, her sinus bradycardia resolved and pulse rate improved. Favipiravir was also considered as the likely cause of sinus bradycardia with causality assessment as probable on Naranjo scale.
Reference
- Habib MB, et al. SEVERE SINUS BRADYCARDIA INDUCED BY FAVIPIRAVIR. Journal of the American College of Cardiology 77 (Suppl. 1): 2978, No. 18, 11 May 2021. Available from: URL: 10.1016/S0735-1097%2821%2904333-3 [abstract] [DOI]