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An event is serious (FDA MedWatch definition) when the patient outcome is:
* congenital anomaly
* requires intervention to prevent permanent impairment or damage
In a retrospective review of 32 infants with posterior fossa, haemangioma, arterial lesions, cardiac abnormalities or aortic coarctation and eye abnormalities (PHACE syndrome), ten infants [sexes not stated] were identified after they developed various toxicities while receiving propranolol [times to reaction onsets not stated].
The infants, who had PHACE syndrome with cervical and intracranial arterial anomalies, were between 2 weeks and 19 months of age when they started receiving oral propranolol 1.0–3.0 mg/kg/day, divided either two or three times daily. The duration of propranolol treatment was 5–18 months. During therapy, two patients experienced sleep disturbance and one patient developed night terrors. Four patients experienced GI upset, asymptomatic h ...
Volume 1451, Issue 1 , p 41
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