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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
* Drug interaction
A 75-year-old man developed acute pain crisis while receiving tramadol and remdesivir, concomitantly.
The man, who had various comorbidities, presented to the emergency department with respiratory symptoms. Initial findings were suggestive of COVID-19 pneumonia. He had been receiving tramadol 50mg four times a day for adequate pain control. Thereafter, he received remdesivir 200mg on day 1 followed by 100mg daily for COVID-19 pneumonia. He had also been receiving various concomitant drugs. On the second day of remdesivir initiation, he developed severe pain in his legs. Later, his dose with tramadol was increased to 100mg. However, he was unable to perform activities of daily living (ADLs) due to intense discomfort. Laboratory investigations showed osteolytic lesions in the lumbar spine consistent with disuse osteopenia related to his incomplete quadriplegia. Examination suggested he was in pain crisis and acutely distressed. Subsequently, he was diagnosed acute pain crisis due to pharmacokinetic interaction between tramadol and remdesivir.
The man was treated with IV fentanyl. Thereafter, treatment with tramadol was switched to oral hydromorphone, where he had complete relief of his pain. During hospitalisation, he received various medications before onset of pain. After hospitalisation, he was back on his home tramadol dosing and he returned to his baseline of adequate pain relief.