Black Box Warning

Spinal or epidural hematomas may occur in patients treated with dabigatran who undergo spinal procedures, including spinal puncture. These hematomas may result in long-term or permanent paralysis. Factors that can increase the risk of developing a spinal or epidural hematoma in these patients include the use of indwelling epidural catheters, concomitant use of other drugs that affect hemostasis (e.g., NSAIDs, platelet inhibitors, other anticoagulants), and traumatic or repeated epidural or spinal punctures. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is required.