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Dabigatran-etexilate Intracranial-haemorrhage, gastrointestinal haemorrhage and medication error: 4 case reports

In a case series study of 8-elderly patients conducted between July 2017 to January 2020, 4 male patients aged 67–90 years were described, who developed intracranial-haemorrhage or gastrointestinal haemorrhage during treatment with dabigatran-etexilate for portomesenteric vein thrombosis or atrial fibrillation (AF). Out of the 4 men, an 87-year old man received inappropriate dose of dabigatran-etexilate [route, duration of treatments to reactions onset not stated]. This report describes a 83-year-old man (case 3 from table 2): The man, had a history of chronic AF (CHA2DS2-VASc-score 5) and had been receiving treatment with dabigatran-etexilate [Dabigatran] 110mg every 12-hours. Currently, he was admitted with low blood pressure, gastrointestinal haemorrhage. Two days before current presentation, he had been discharged after admission for constrictive pericarditis requiring total pericardiectomy and had received unspecified corticosteroids, ibuprofen and colchicine. At current admission, resuscitation was performed with crystalloids, IV omeprazole, RBC transfusion and unspecified vasopressors. Upper gastrointestinal videoendoscopy (UGIVE) showed gastric ulcers. Video-colonoscopy (VC) findings were consistent with ischaemic colitis without evidence of active bleeding. Laboratory results showed fall in haematocrit levels. However, he had developed hypovolaemic shock due to GI bleeding. As a result, he was treated with idarucizumab on the day 7 of admission for reversal of dabigatran-etexilate effect. Subsequently, adequate control of bleeding was achieved post reversal within 24 hours along with restoration of haemodynamic stability. Unfortunately, 9 days after reversion he died due to hospital-acquired pneumonia. This report describes a 90-year-old man (case 6 from table 2): The man, had history of ischaemic heart disease with severe ventricular dysfunction, a transient ischaemic attack 12-years ago and AF (CHA2DS2-VASc-score 7). He had been receiving treatment with dabigatran-etexilate 110mg every 12-hours for AF. Concomitantly, he received diclofenac. However, he was admitted with gastrointestinal haemorrhage from 4 days. UGIVE findings revealed haematologic debris and giant ulcer. Subsequently, he developed hypovolaemic shock due to GI bleeding. Thus, he required orotracheal intubation, crystalloid resuscitation, IV omeprazole, tranexamic acid and unspecified inotropes along with two units of RBCs were transfused and idarucizumab was administered resulting in haemodynamic stability and recovery of renal failure. He was successfully extubated on the day 5 and without any new bleeding related complications. Unfortunately, he died after 60 days of admission due to hospitalacquired pneumonia. This report describes a 87-year-old man (case 7 from table 2): The man, had history of AF (CHA2DS2-VASc-score 5) and received inappropriate dose (medication error) of dabigatran-etexilate 150mg every 12-hours ins