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Dabigatran

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 (2.42.52.6) 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)].

FDA and Industry Communications

Index to FDA Drug Safety Information 

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Patient Medication Guide

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Dabigatran

Updated January 2018