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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 36-year-old man developed non-specific psychotic disorder and hypotension following the discontinuation of oxycodone/naloxone, which was administered for non-inflammatory chronic rachialgia.
The man, who had non-inflammatory chronic rachialgia, was hospitalised in the psychiatric unit with unspecific psychiatric disorder (delusions, hallucinations and aberrant behaviour), which was considered probably related to withdrawal of oxycodone/naloxone. He had been treated with pregabalin, diazepam, baclofen and oxycodone/naloxone 5/2.5mg every 12h [route not stated] for non-inflammatory chronic rachialgia. Ten days prior to admission, he had discontinued oxycodone/naloxone and developed delusions of being drugged and harmed, along with possible olfactory and kinesthetic...
- Casado-Espada NM, et al. Psychotic symptoms following oxycodone withdrawal, case report and update. European Review for Medical and Pharmacological Sciences 23: 6315-6320, No. 14, 2019. Available from: URL: http://doi.org/10.26355/eurrev_201907_18454 - Spain