Michael Rolfe
7 Sept 2022 · Coroner Paul Cooper · Lincolnshire
The coroner's concerns
1. inappropriate prescription of Rivaroxaban in liver impairment and renal dysfunction
“The deceased had liver impairment due to cirrhosis. He was prescribed the anticoagulant Rivaroxaban for presumed deep vein thrombosis. Within 48 hours he developed rectal bleeding. During his admission to hospital his INR was 1.8 indicating blood was thin. Renal function impaired with a GFR of 39 - baseline 46. Rivaroxaban is contradicted in liver impairment, low platelets and severe renal impairment .(Documented in the product literature and British National Formulary). Consequently, it is represented that the deceased should not have been prescribed Rivaroxaban due to the bleeding risk. Administration of Rivaroxaban to someone with impaired clotting and low platelets would exaggerate the anticoagulant effect and be responsible for the rectal bleed and cerebral haemorrhage that resulted. If accepted the potential inappropriate administration may have led to the cause of death and this has important safety implications that are in the public interest. An action plan to prevent future deaths may be needed.”
2. use of Rivaroxaban in contraindicated conditions
“Rivaroxaban is contradicted in liver impairment, low platelets and severe renal impairment”
3. liver impairment as risk factor for adverse drug reaction
“The deceased had liver impairment due to cirrhosis”
4. prescription of anticoagulant without confirming DVT
“He was prescribed the anticoagulant Rivaroxaban for presumed deep vein thrombosis”
5. fatal hemorrhage as direct result of medication error
“Within 48 hours he developed rectal bleeding”
6. severe renal impairment as risk factor
“Renal function impaired with a GFR of 39 - baseline 46”