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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series, 4 patients [2 men and 2 women] aged 35−51 years were described, who developed confusion, lethargy, slurred speech, appeared unsteady, swaying, bad driving, difficult time while following instruction, extreme impairment, unusual behaviour, hallucination, talkativeness, violent body tremors, horizontal gaze nystagmus (HGN), aberrant behaviour, lack of smooth pursuit, white frothing at mouth and teeth grinding while receiving buprenorphine, buprenorphine/naloxone, dextromethorphan, diphenhydramine, methylphenidate, nicotine or zolpidem [duration of treatments to reactions onsets and outcomes not stated; not all dosages, routes and indications stated].
Case 1: A 39-year-old man 1was found unconscious by a civilian witness after vehicle stuck in a snow bank at a...