BlackBoxRX
 
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Baclofen (Intrathecal)

Abrupt Discontinuation

  • Abrupt discontinuation has resulted in high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity that in rare cases advances to rhabdomyolysis, multiple organ system failure and death.
  • Careful attention to proper programming and monitoring of infusion system, refill schedules and procedures, and pump alarms to avoid abrupt withdrawal
  • Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be
    educated on the early symptoms of baclofen withdrawal
  • Special attention should be given to patients at apparent risk(e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).
  • Consult the technical manual of the implantable infusion system for additional post implant clinician and patient information.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Careful attention to proper programming and monitoring of infusion system, refill schedules and procedures, and pump alarms to avoid abrupt withdrawal
  • Advise patient and caregivers of compliance importance
  • Black box data added April 2002
  • Special attention should be given to patients at apparent risk(e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).
  • Consult the technical manual of the implantable infusion system for additional post implant clinician and patient information.

Patient Counseling Information

Package Inserts

Baclofen

Gablofen

Additional Information

Updated January 2018