Severe Drug-Induced Skin and Liver Injury from Rivaroxaban
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Rivaroxaban, a direct factor Xa (FXa) inhibitor, is a new oral anticoagulant approved for use in the USA in 2011 for the prevention of deep vein thrombosis in patients undergoing knee and hip replacement surgery. Direct FXa inhibitors generated $2.1 billion in 2013, with rivaroxaban accounting for 93.6 % of sales due to label expansion to cover for additional indications [1, 2]. Concern for drug-induced liver injury (DILI) from new oral anticoagulants has lingered ever since the termination of the ximelagatran development program . Recent recognition of several spontaneous reports in the pharmacovigilance systems has unfortunately rekindled this concern . A careful analysis of an individual case of suspected DILI from rivaroxaban is therefore very important as the causality assessment in these spontaneous reports is not very robust due to lack of complete information.
Objective and Methods
The objective was to describe an individual who developed jaundice with...
KeywordsAdverse drug reaction Hepatotoxicity Drug-induced skin reaction DRESS
Conflict of interest
- 1.FDA expands use of Xarelto to treat, reduce recurrence of blood clots. 2012. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm326654.htm. Accessed on 9/2/2014.
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