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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 59-year-old man developed an elevated ALT and sinus bradycardia during treatment with remdesivir for SARS-CoV-2 infection. He also received off-label convalescent-anti-SARS-CoV-2-plasma for SARS-CoV-2 infection [not all routes, dosages and duration of treatment to reactions onset stated].
The man presented to hospital with shortness of breath and cough. One week previously, he had been diagnosed with SARS-CoV-2 infection. His medical history was unremarkable, and he was not receiving any medications. Following examination, he started receiving dexamethasone and enoxaparin-sodium [enoxaparin] for prophylaxis of deep vein thrombosis along with oxygen therapy via nasal prong cannula. On day 2 of admission, he started receiving treatment with off-label convalescent-anti-SARS-CoV-2-plasma [convalescent plasma]. Additionally, he received IV remdesivir at a loading dose of 200mg on day 2, followed by 100mg IV on day 3 and daily thereafter for SARS-CoV-2 infection. After the third dose of remdesivir, on day 4, he experienced sinus bradycardia with an HR of 50 beats/min. He did not experience lightheadedness or unconsciousness but had fatigue, generalised weakness and headache with no signs of increased vagal tone, nausea, pain or constipation. Blood examination revealed elevated ALT, normal electrolytes, C-reactive protein and thyroid-stimulating hormone. A score of 6 was observed on the Naranjo Adverse Drug Reaction Probability Scale, suggesting a probable causative association between remdesivir and bradycardia.
The man's therapy with remdesivir was discontinued on day 5. After discontinuation of the drug, his HR began to increase, and on day 7, his HR returned to a normal rate. His ALT was noted to be 133 unit/L. He was discharged home, and the treatment with remdesivir was not restarted.
Reference
- Day LB, et al. Bradycardia associated with remdesivir therapy for COVID-19 in a 59-year-old man. CMAJ: Canadian Medical Association Journal 193: E612-E615, No. 17, 26 Apr 2021. Available from: URL: 10.1503/cmaj.210300 [DOI] [PMC free article] [PubMed]