A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that
the benefits of a drug outweigh its risks. The FDA has required a REMS for ELIQUIS.
The purpose of the ELIQUIS REMS is to inform healthcare providers about:
- the increased risk of thrombotic events, including stroke, in patients with nonvalvular atrial fibrillation when discontinuing ELIQUIS without introducing an adequate alternative anticoagulant
- the importance of following the recommendations in the US Prescribing Information (USPI) on how to convert patients with nonvalvular atrial fibrillation from ELIQUIS to warfarin or other anticoagulants.