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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
The cases recorded in the AMSP Multicenter Drug Safety Surveillance Project described three patients (one male and two females) aged 57−73 years, who developed drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome during treatment with sertraline or clozapine and sertraline [routes not stated]. Additionally, in two of these three patients, it was noted that clozapine levels were in the toxic range despite normal dosages.
Case 1: A 73-year-old man, who was admitted to the psychiatric hospital for an acute exacerbation of a chronic paranoid schizophrenia, started receiving daily clozapine therapy [initial dose not stated], and the dose was subsequently increased up to 400 mg/day. He was also receiving few other concomitant medications. On day 20 of the...
- Sanader B, et al. Clozapine-Induced DRESS Syndrome: A Case Series From the AMSP Multicenter Drug Safety Surveillance Project. Pharmacopsychiatry 2018: 2018. Available from: URL: http://doi.org/10.1055/a-0586-8983 - Germany