Dabigatran etexilate

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

A 51-year-old man developed cholestatic liver injury while receiving anticoagulant therapy with dabigatran etexilate.

The man, who had diabetes, presented with a 6-day history of fever, cough and myalgia on 8 July 2020. Based on the investigations, he was diagnosed with COVID-19 pneumonia. He was treated with off label ascorbic acid [vitamin-C], zinc supplements, esomeprazole, IV methylprednisolone and SC enoxaparin sodium [enoxaparin] for 3 days, resulting in clinical recovery and he was discharged on day 4 on methylprednisolone 16 mg/day for a week followed by 8 mg/day for a week, and an oral anticoagulant dabigatran etexilate [dabigatran] two times everyday for 4 weeks. On 30 July 2020, he presented again with a 5-day history of jaundice, poor appetite, pruritus and yellowish urine.

Dabigatran was stopped in the third week of August, and the man was admitted on 30 August 2020. At that time, he was deeply jaundiced and had intense pruritus. Laboratory investigations revealed the following: AST 36 U/L, ALT 41 U/L, bilirubin 39.1 g/dL, alkaline phosphatase 298 U/L, γ-glutamyl transferase 243 U/L, albumin 3.9 mg/dl and INR 1.2. Further abdominal ultrasound showed mild hepatomegaly. His COVID-19 IgG antibody has turned negative by then. A percutaneous liver biopsy revealed largely maintained lobular architecture with prominent centrilobular hepatocanalicular bilirubinostasis, mild lobular activity and hepatocellular ballooning. Based on the findings, he was diagnosed with dabigatran etexilate induced cholestatic liver injury. He was treated with cholestyramine for pruritus and a session of therapeutic plasma exchange. Subsequently, His clinical symptoms improved. Also, a reduction in jaundice was noted.