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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
* Drug overdose
* Drug interaction
In a case series, four men were described, who developed decreased anticoagulant activity during concomitant administration of ledipasvir/sofosbuvir and warfarin; of these four men, one man developed upper gastrointestinal bleeding secondary to increased anticoagulant activity during treatment with warfarin, and one man developed increased anticoagulant activity following an accidental overdose of warfarin [routes not stated; not all dosages and not all durations of treatments to reactions onsets stated].
Patient one: A 64-year-old man with chronic hepatitis C, started receiving 24 weeks treatment with ledipasvir/sofosbuvir in late 2015. Additionally, he was receiving warfarin since 2011 for atrial fibrillation, with...