Cañamares Orbis I1, Tojo Thomas de Carranza T2, Fortea Sola A3, Gómez Cabezuelo Y4
1 Farmacéutica Especialista en Farmacia Hospitalaria. Subdirección General de Farmacia y Productos Sanitarios, Madrid (España)
2 Médico Especialista en Medicina Familiar y Comunitaria. Residencia de Mayores Goya, Agencia Madrileña de Atención Social, Madrid (España)
3 Fisioterapeuta. Residencia de Mayores Goya, Agencia Madrileña de Atención Social, Madrid (España)
4 Enfermera. Directora Residencia de Mayores Goya, Agencia Madrileña de Atención Social, Madrid (España)
Fecha de recepción: 27/04/2018 – Fecha de aceptación: 10/06/2018
Correspondencia: Iciar Cañamares Orbis w Subdirección General de Farmacia y Productos Sanitarios. Consejería de Sanidad. Servicio Madrileño de Salud w Plaza Carlos Trias Bertrán, 7. Edificio Sollube, 5ª planta w 28020 Madrid (España)
iciar.canamares@salud.madrid.org
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Summary
Rivaroxaban is a direct-acting oral anticoagulant (DOAC). It is a direct thrombin and factor Xa (activated factor X) inhibitor, approved for prevention and treatment of venous thromboembolism (VTE) after elective hip and knee replacement surgery. And has been approved for prevention of stroke in non-valvular atrial fibrillation. The main difference with K-vitamin derivatives is that it does not require INR periodic monitoring.
We present a case report of an 84 years old woman with history of atrial fibrillation in treatment with acenocoumarol (a vitamin K antagonist) having suboptimal INR control that meets criteria for changing to rivaroxaban. After 17 days of treatment start, the patient suffered an adverse drug reaction that requires hospitalization. Although hepatobiliary disorders appear as post-marketing observations in the summary of product characteristics, in our case a highly probable causal relationship was established.
Key words: Chemical and drug-induced liver injury, anticoagulants, rivaroxaban, adverse drug reaction, causality.
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