Química Farmacéutica · 2019

Caracterización de eventos adversos y problemas relacionados con Rivaroxaban reportadas al prorama Mundial de Farmacovigilacia 2006-2018

Background: VTE represents an important health challenge that causes great impact to millions of people and the established anticoagulants used to prevent or treat the disease have significant limitations, including the need for parenteral administration, regular monitoring and lack of predictable response. Rivaroxaban was approved by the European authorities in 2008 for the prevention of venous thromboembolism (VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism) after elective hip or knee replacement. One of the main reasons for the importance of the discovery of this molecule called Rivaroxaban is its significant contribution to the treatment and prevention of venous thromboembolism (VTE). VTE represents an important health challenge that causes great impact to millions of people and the established anticoagulants used to prevent or treat the disease have significant limitations, including the need for parenteral administration, regular monitoring and lack of predictable response. The aim of the present study is to characterize the adverse events with Rivaroxaban reported to the World Pharmacovigilance Program in the period 2006-2018. Methods: Retrospective descriptive observational study, cases reported by the Uppsala Monitoring Center database worldwide. Results: During the period January 1st 2006 to November 20th 2018 was found 224.320 adverse events mostly, about (39%) related with hemhorrages, Mainly gastrointestinal bleeding is the most augmented adverse reaction for Rivaroxaban with no distinction of gender. Age is a risk factor for population >75 years old. América is the continent with more adverse reactions reported, this because of the active pharmacovigilance plans that this continent has. Some of the problem related with rivaroxaban being an anticoagulant are related with over-dosification or Quality problems like label, package where rivaroxaban is contained. Conclusions: Adverse events are most likely gastrointestinal disorders. The more are gastrointestinal bleeding, event which is a preoccupation for gastroenterologists. The pharmaceutical attention is a network whose strategy is being aware of the complications that the patient has when is prescribed with new anticoagulants with rivaroxaban. It has been made a proposal communicative piece in order to inform possible risks related with anticoagulant therapy.

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