Adverse events associated with the use of direct-acting oral anticoagulants in clinical practice: beyond bleeding complications.

Adverse events associated with the use of direct-acting oral anticoagulants in clinical practice: beyond bleeding complications. Pol Arch Med Wewn. 2016 Aug 25;126(7-8):552-61 Authors: Raschi E, Bianchin M, Ageno W, De Ponti R, De Ponti F Abstract Non-vitamin K oral anticoagulants, also known as direct oral anticoagulants (DOACs), have entered the market in 2008 with the expected breakthrough potential of circumventing limitations related to treatment with vitamin K antagonists (eg, warfarin) by virtue of their pharmacological properties. Although data derived from premarketing randomized clinical trials have largely demonstrated the clinical benefit of DOACs, especially in terms of reduced risk of intracranial bleeding, it is important to monitor the safety in the postmarketing phase, which better reflects real-world patients with comorbidities and polypharmacotherapy, in order to assess the actual risk-benefit profile. In this critical review, we aimed to evaluate the evidence on the latest debated safety issues. In the first section, we will discuss: 1) the need for pharmacovigilance (ie, the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems in the real-world setting), and 2) the importance of properly interpreting postmarketing data to avoid unnecessary alarm. In the second section, emerging and debated safety issues potenti...
Source: Polskie Archiwum Medycyny Wewnetrznej - Category: Internal Medicine Tags: Pol Arch Med Wewn Source Type: research