- 116 Downloads
An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a study of patients with priapism reported to the programme 'Arzneimittelsicherheit in der Psychiatrie' (AMSP) between 1994 and 2016, 19 men (aged 24−53 years) were described, who developed priapism during treatment with aripiprazole, clozapine, fluphenazine, haloperidol, olanzapine, promazine, quetiapine, risperidone, thioridazine, trazodone or zuclopenthixol [not all routes, dosages, time to reactions onsets and outcomes stated].
A 30-year-old man, who had schizophrenia, received aripiprazole 15 mg/day for 6 days. Then, the dose was increased to 30 mg/day for 5 days, followed by 45 mg/day. However, 1 month following the initiation of aripiprazole, he developed priapism that lasted for 3 days. He was then found to have developed erectile dysfunction. Treatment with...