Acute liver failure after initiation of rivaroxaban: A case report and review of the literature

Abstract

Context:Rivaroxaban is a direct factor Xa inhibitor approved for the prevention of thromboembolism. Drug induced liver injury has been increasingly reported with rivaroxaban recently, but actual liver failure has not been reported.Case Report:We present a case report on the probable occurrence of acute liver failure with rivaroxaban therapy. An 89 year old woman with history of atrial fibrillation was hospitalized for biventricular congestive heart failure with passive congestion of liver, which responded to furosemide. She was discharged home on rivaroxaban for prevention of thrombo-embolism. Liver function tests upon discharge returned to almost normal range. One week later, she presented with abdominal pain and was found to have highly elevated liver enzymes, elevated bilirubin, and an abnormal coagulation profile. A day later, she developed hepatic encephalopathy, suggesting liver failure.Conclusion:Liver enzymes declined rapidly with the discontinuation of all of her medications, however patient died because of multi-organ failure. The causality assessment in this patient was “probable” with rivaroxaban.

Rivaroxaban-induced hepatotoxicity: review of the literature and report of new cases

“…Twenty-six cases of acute or subacute liver damage following rivaroxaban exposure were retrieved from MEDLINE search between the years 2008 and 2016 (Table 1) [11,[16][17][18][19][20][21][22]. Fifteen (57.7%) patients were female and 11 (42.3%) male.…”

“…Recovery was generally observed, with the exception of two patients. One of 11 cases with predominantly hepatocellular injury (n = 11) resulted in death [18] from acute liver failure. Among the cholestatic cases (n = 7), one died of paralytic ileus [11].…”

“…Severe and even fatal cases of acute liver toxicity in patients treated with rivaroxaban have been reported in the literature [2,11,[16][17][18][19][20][21][22]. To date, rivaroxaban-induced liver injury events have been described in several case reports: in this study, we reviewed 26 published clinical reports and have added two new cases in which hepatotoxicity, assessed by RUCAM as 'probable' or 'highly probable', was the main adverse event.…”

“…In fact, in all the cases reviewed rivaroxaban was given at therapeutic doses. In addition, in some of the reports, older-aged patients were taking other medications that might have contributed to the liver injury [11,[16][17][18]20].…”

Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions

“…Some clinical trials described rare cases of DILI with DOACs; however, DOACs induced liver injury is considered an idiosyncratic reaction, therefore insufficient number of patients, exclusion criteria such as pre‐existing liver disease and short duration of treatment, make it difficult to provide reliable data in the premarketing phase . Case reports regarding rivaroxaban have been already published .…”