An event is serious (FDA MedWatch definition) when the patient outcome is:
* congenital anomaly
* requires intervention to prevent permanent impairment or damage
A 16-year-old girl developed neuropsychiatric effects due to chloroquine intoxication which were prolonged during treatment with benzatropine, diphenhydramine, olanzapine, fluoxetine, risperidone and rivastigmine [not all routes and dosages stated].
The girl, while volunteering in Honduras, became ill during her ninth week of chloroquine prophylaxis 250mg weekly. She developed insomnia, paranoia and confusion which progressed in severity over the next 2 days. Following a dose of diphenhydramine to aid sleep, her symptoms progressed to hallucinations, irrational guilt, self persecution, suicidal ideation and catatonic features. Upon repatriation to the US 2 days later, she was admitted to the emergency room of local hospital where she received...