Lioresal® Intrathecal Underdose/Withdrawal In the U.S., emergency technical support is available 24 hours/day for clinicians managing patients with Medtronic SynchroMed® Infusion System implants: 800-707-0933. In other world areas, contact your Medtronic representative. E M E r g E n c y P r o c E d U r E
The physician experienced with ITB Therapy should expeditiously attempt device troubleshooting. This may include, but is not limited to:
Symptoms of Underdose Return of baseline spasticity, pruritus, hypotension, paresthesias, fever, and altered mental state.
• interrogation of the pump status using the Medtronic pump programmer
Symptoms of Intrathecal Baclofen Withdrawal
• radiologic examination of the pump and catheter system
High fever, altered mental status, exaggerated rebound spasticity and muscle rigidity that in rare cases has advanced to rhabdomyolysis, multiple organ system failure and death.
• a pump refill procedure with the appropriate concentration of baclofen
The condition may resemble autonomic dysreflexia, sepsis, malignant hyperthermia, and neuroleptic-malignant syndrome.
• system troubleshooting procedures to determine the cause of ITB Therapy interruption
Medtronic SynchroMed Infusion System
• surgical repair, revision, or replacement of system components
The SynchroMed Infusion System consists of an implantable programmable pump, intraspinal catheter and
pump programmer. The pump is implanted in the lower abdomen and dispenses medication from its
reservoir through the catheter to the intrathecal or epidural space. Some pumps are equipped with a cath-
eter access port that bypasses the pump reservoir, permitting direct catheter access to the intrathecal or
Baclofen withdrawal has been identified during post-approval use of Lioresal® Intrathecal
(baclofen injection). Because this reaction is reported spontaneously from a population of
Suggested Treatment for Intrathecal Baclofen Underdose/Withdrawal
uncertain size, it is not possible to reliably estimate the frequency.
Abrupt withdrawal of intrathecal baclofen, regardless of the cause, has, in rare cases,
resulted in a life-threatening syndrome that included high fever, altered mental status,
exaggerated rebound spasticity and muscle rigidity that progressed to rhabdomyolysis,
multiple organ-system failure, and death.
If a patient receiving ITB TherapySM (Intrathecal Baclofen Therapy) presents with the signs and
symptoms suggestive of baclofen withdrawal (above), the following approach is consistent with
that suggested by a panel of therapy-experienced clinicians convened to explore this issue:1
All patients receiving ITB Therapy are potentially at risk. Some clinical characteristics
of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic
1. Immediately contact a physician experienced in ITB Therapy, preferably the physician manag-
dysreflexia, or infection (sepsis), malignant hyperthermia, neuroleptic-malignant
ing the therapy for the patient in question; follow the recommendations of this physician. This
syndrome, and other conditions associated with a hypermetabolic state or widespread
step is important even if the patient’s signs and symptoms seem mild.
rhabdomyolysis. A rapid and accurate diagnosis is important in an emergency room
2. If an ITB Therapy physician is unavailable, consider instituting one or more of the following
or intensive care setting before initiating treatment in order to prevent the potentially
options, unless otherwise contraindicated:
life-threatening central nervous and systemic effects of intrathecal baclofen withdrawal.
• restoration of intrathecal baclofen infusion
• intravenous benzodiazepines by continuous or intermittent infusion, titrating the dosage
until the desired therapeutic effect is achieved
*Note: Oral baclofen should not be relied upon as the sole treatment for intrathecal baclofen
Name: ______________________________ Phone: ____________________________
City: ______________________________ State: ____________________________
Report incident to Medtronic, Inc. In the U.S. call 1-800-707-0933.
In other world areas contact your Medtronic representative.
Refer to the drug manufacturer’s package insert for a complete list of indications, contraindications, warnings, precautions, adverse events, and dosage and administration information. 1Coffey RJ, Edgar TS, Francisco GE, et al. Abrupt withdrawal from intrathecal baclofen: recognition and management of a potentially life-threatening syndrome. Arch Phys Med Rehabil: Vol. 83. June, 2002. pp735-41Lioresal® is a registered trademark of Medtronic, Inc.
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