Premature Discontinuation Increases the Risk of Thrombotic Events; Spinal/Epidural Hematoma

Premature Discontinuation Increases Risk of Thrombotic Events

• Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.4, 2.5, 2.6) and Warnings and Precautions (5.1)]. 

Spinal/Epidural Hematoma

• Epidural or spinal hematomas may occur in patients treated with PRADAXA 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:?
            a. use of indwelling epidural catheters
            b. concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants 
            c. a history of traumatic or repeated epidural or spinal punctures
            d. a history of spinal deformity or spinal surgery
            e. optimal timing between the administration of PRADAXA and neuraxial procedures is not known[see Warnings and Precautions (5.3)].
• Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.3)].
• Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions (5.3)].