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U.S. Department of Health and Human Services

Safety

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Eliquis (apixaban) 2.5 and 5 mg Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

August 2014

Summary View

BOXED WARNING

WARNING: PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS…

PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including Eliquis, increases the risk of thrombotic events. If anticoagulation with Eliquis is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant…

WARNINGS AND PRECAUTIONS

Increased Risk of Thrombotic Events after Premature Discontinuation
  • Premature discontinuation of any oral anticoagulant, including Eliquis, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Eliquis to warfarin in clinical trials in atrial fibrillation patients. If Eliquis is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

 

January 2014

Summary View

8 USE IN SPECIFIC POPULATIONS

8.6 End-Stage Renal Disease Patients Maintained with Hemodialysis
  • new subsection added


note: also changes to DOSAGE AND ADMINISTRATION, 2.7 Renal Impairment