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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a prospective study of 7 men, 5 men aged between 63-90 years were described, who developed Torsades de pointes (TdP) while receiving treatment with spiramycin, sotalol, hydroxyzine, amiodarone, ciprofloxacin or fluconazole 1 [dosages, routes and durations of treatments to reactions onsets not stated].
Patient 1: A 72-year-old man, who had a history of hypertension, ischaemic cardiomyopathy, langerhans cell histiocytosis infiltrating multiple organs with BRAF mutation (ECD), lung infection and hypogonadism, was receiving treatment with spiramycin [dosage and route not stated] for lung infection. He developed respiratory distress and recurrent episodes of TdP with prolonged QT interval (QTc >550ms). Six cardioversions were required for post-TdP ventricular fibrillation. His...