Pharmacovigilance for Novel Oral Anticoagulants: Why is It So Crucial?

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Pharmacovigilance for Novel Oral Anticoagulants: Why is It So Crucial?

Novel oral anticoagulants (NOACs) inhibit key enzymes in the coagulation cascade namely thrombin and activated factor X (FXa). NOACs already approved are the thrombin inhibitor dabigatran etexilate and the FXa inhibitors rivaroxaban and apixaban. These drugs have been licensed for the treatment of deep vein thrombosis and for the treatment of non valvular atrial fibrillation. Non-valvular atrial fibrillation is a quite common arrhythmia and its prevalence increases with age. According to epidemiological data, non valvular atrial fibrillation is more common in people older than 80 years old. People suffering from atrial fibrillation have increased risk of embolic stroke. Chronic treatment with oral anticoagulants reduces the risk of stroke. Oral anticoagulation therapy is recommended for patients with two or more risk factors for thromboembolism in addition to atrial fibrillation. Patients with atrial fibrillation and a single additional risk factor should be evaluated on an individual basis for the possible need of anticoagulant treatment. Anticoagulant treatment is not recommended for people with atrial fibrillation and no other risk factors. Until recently, patients with atrial fibrillation were treated with warfarin or closely related vitamin K antagonists. However, these medicines need tight coagulation monitoring as their pharmacokinetics cannot be predicted.

Citation: Yiannakopoulou ECh (2015) Pharmacovigilance for Novel Oral Anticoagulants: Why is It So Crucial?. J Pharmacovigilance 3:e135.

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