• 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
• 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.

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.

FDA and Industry Communications

Black Box revision: Dear Health Professional Letter (April 2002)

Patient Counseling Information

• Kemstro

Package Inserts

Baclofen