Rivaroxaban postmarketing risk of liver injury

Rivaroxaban postmarketing risk of liver injury.

BACKGROUND & AIMS Rivaroxaban is an oral direct factor Xa inhibitor that has been marketed worldwide since 2008 for the primary and secondary prevention and treatment of thromboembolic disorders. Although liver injury was observed in premarketing trials of rivaroxaban, there are no published postmarketing cases of liver injury associated with rivaroxaban. METHODS Report of 14 cases of liver i...

Postmarketing surveillance of injury countermeasures.

Symptomatic hepatocellular liver injury with hyperbilirubinemia in two patients treated with rivaroxaban.

IMPORTANCE Treatment with the new oral anticoagulant rivaroxaban can be associated with severe liver injury. OBSERVATIONS We report 2 patients with predominantly hepatocellular liver injury that had onset during treatment with rivaroxaban. Both were symptomatic, had massively elevated transaminase activity levels and hyperbilirubinemia, and fulfilled the criteria of Hy's law. Liver biopsy in ...

Postmarketing Evaluation of Drugs

Round table no. 2 was devoted to the postmarketing evaluation of drugs. The debates involved both the questions posed by postmarketing evaluation and the methods for responding to them. The major categories of questions likely to be posed are as follows: efficacy in actual situations; safety in actual situations; prognostic factors and patients responding; place in the therapeutic strategy; imp...

Drug-induced liver injury: Towards early prediction and risk stratification

Drug-induced liver injury (DILI) is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications and agents listed as causing liver damage (http://livertox.nih.gov/). As it was the case in the past decade with drug-induced QT prolongation/arrhythmia, there is an urgent unmet clinical need to develop tools for risk assessment and...