lunedì 6 gennaio 2014

IMPORTANT DRUG WARNING ELIQUIS® (apixaban) tablets

Dear Healthcare Professional:

The purpose of this letter is to inform you of important safety information for ELIQUIS (apixaban). ELIQUIS is an oral, reversible factor Xa inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 
The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of ELIQUIS outweigh the potential risks in patients with nonvalvular atrial fibrillation including:

  • Increased risk of thrombotic events, including stroke, when discontinuing ELIQUIS without an adequate alternative anticoagulant
Please read the recommendations in the US Prescribing Information (USPI) on how to convert patients with nonvalvular atrial fibrillation from ELIQUIS to warfarin or other anticoagulants.
The ELIQUIS® labeling includes a BOXED WARNING to highlight the safety issue of increased risk of thrombotic events following discontinuation of ELIQUIS®

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