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PRESCRIBED
NOAC IN THE US*1
†2-13
BEYOND EXTENSIVE RANDOMIZED CLINICAL TRIALS,
PUBLISHED SAFETY OUTCOMES FROM OBSERVATIONAL STUDIES
OF REAL-WORLD PATIENTS†2-13
NOAC = non-vitamin K antagonist oral anticoagulant.
*Among Factor Xa inhibitors and direct thrombin inhibitors.
Based on the following registries, claims databases, and studies: Optum Labs=16,253; IMS Health LifeLink=1,649; Truven Health=5,563; Danish registry=1,303;
XAMOS=8,778; Symphony=3,654; ORTHO-TEP=1,043; Japanese registry=1,035; Dresden NOAC=1,776; XALIA=2,505; DOD database=27,467; XANTUS=6,784.
†
IMPORTANT SAFETY INFORMATION
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO®
INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/
EPIDURAL HEMATOMA
A. PREMATURE DISCONTINUATION OF XARELTO INCREASES
THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant,
including XARELTO®, increases the risk of thrombotic
events. If anticoagulation with XARELTO® is
discontinued for a reason other than pathological
bleeding or completion of a course of therapy, consider
coverage with another anticoagulant.
®
B. SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas have occurred in patients
treated with XARELTO® who are receiving neuraxial
anesthesia or undergoing spinal puncture. These
hematomas may result in long-term or permanent
paralysis. Consider these risks when scheduling patients
for spinal procedures. Factors that can increase the risk
of developing epidural or spinal hematomas in these
patients include:
Use of indwelling epidural catheters
Concomitant use of other drugs that affect hemostasis,
such as non-steroidal anti-inflammatory drugs
(NSAIDs), platelet inhib