Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include 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.
Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. 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 postimplant clinician and patient information (see WARNINGS).
LIORESAL® INTRATHECAL (baclofen injection) is a muscle relaxant and antispastic.
LIORESAL INTRATHECAL (baclofen injection) is indicated for use in the management of
severe spasticity. Patients should first respond to a screening dose of
intrathecal baclofen prior to consideration for long term infusion via an
implantable pump. For spasticity of spinal cord origin, chronic infusion of
LIORESAL INTRATHECAL via an implantable pump should be reserved for patients
unresponsive to oral baclofen therapy, or those who experience intolerable CNS
side effects at effective doses. Patients with spasticity due to traumatic brain
injury should wait at least one year after the injury before consideration of
long term intrathecal baclofen therapy. LIORESAL INTRATHECAL is intended for use by the intrathecal route in single bolus test
doses (via spinal catheter or lumbar puncture) and, for chronic use, only in
implantable pumps approved by the FDA specifically for the administration of
LIORESAL INTRATHECAL into the intrathecal space.
Spasticity of Spinal Cord Origin: Evidence supporting
the efficacy of LIORESAL INTRATHECAL was obtained in randomized, controlled
investigations that compared the effects of either a single intrathecal dose or
a three day intrathecal infusion of LIORESAL INTRATHECAL to placebo in patients
with severe spasticity and spasms due to either spinal cord trauma or multiple
sclerosis. LIORESAL INTRATHECAL was superior to placebo on both principal
outcome measures employed: change from baseline in the Ashworth rating of
spasticity and the frequency of spasms.
Spasticity of Cerebral Origin: The efficacy of
LIORESAL INTRATHECAL was investigated in three controlled clinical trials; two
enrolled patients with cerebral palsy and one enrolled patients with spasticity
due to previous brain injury. The first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically
significant results; LIORESAL INTRATHECAL was superior to placebo in reducing
spasticity as measured by the Ashworth Scale. A second cross-over study was
conducted in 11 patients with spasticity arising from brain injury. Despite the
small sample size, the study yielded a nearly significant test statistic (p=0.066) and provided directionally favorable results. The last study, however,
did not provide data that could be reliably analyzed.
LIORESAL INTRATHECAL therapy may be considered an alternative to destructive
neurosurgical procedures. Prior to implantation of a device for chronic
intrathecal infusion of LIORESAL INTRATHECAL, patients must show a response to
LIORESAL INTRATHECAL in a screening trial (see Dosage and Administration).
Published Studies Related to Lioresal (Baclofen Intrathecal)
Baclofen for the Treatment of Alcohol Dependence and Possible Role of Comorbid
baclofen in the treatment of alcohol dependence... CONCLUSIONS: In spite of the small sample for a 3-arm clinical trial, this study
Randomised clinical trial: arbaclofen placarbil in gastro-oesophageal reflux
disease--insights into study design for transient lower sphincter relaxation
characteristics of patients who were responders... CONCLUSIONS: Arbaclofen placarbil was not superior to placebo in the primary
Baclofen reduces binge eating in a double-blind, placebo-controlled, crossover
Baclofen has shown promise in treating substance use disorders and also reduced
binge frequency in an open-label trial...
Defining the Role of Baclofen for the Treatment of Alcohol Dependence: A Systematic Review of the Evidence. [2011.12.06]
The pharmacological properties of baclofen, a GABA(B) receptor agonist, have led to investigation of its use for the off-label treatment of alcohol dependence. Literature examining the role of baclofen in alcohol dependence suggests that it may be a useful medication in the treatment armamentarium with an additional benefit of promoting abstinence and reducing alcohol-associated cravings and anxiety...
treating alcohol withdrawal with oral baclofen: a randomized, double-blind, placebo-controlled trial. [2011.10]
BACKGROUND: Abrupt cessation of alcohol intake causes habituated drinkers to experience symptoms of alcohol withdrawal syndrome (AWS). OBJECTIVE: To determine the effect of the gamma-aminobutyric acid (GABA)-B agonist baclofen on the course of acute symptomatic AWS... CONCLUSIONS: We found that the use of baclofen was associated with a significant reduction in the use of high doses of benzodiazepine (lorazepam) in the management of symptomatic AWS. The use of low-dose baclofen in the management of AWS deserves further study, as reduced dependence on high-dose benzodiazepines in AWS management could improve patient safety. Copyright (c) 2011 Society of Hospital Medicine.
Reports of Suspected Lioresal (Baclofen Intrathecal) Side Effects
Muscle Spasticity (125),
Drug Withdrawal Syndrome (82),
Condition Aggravated (71),
Implant Site Infection (61),
Implant Site Effusion (55),
Muscle Spasms (52),
Medical Device Complication (47),
Device Dislocation (44),
Overdose (44), more >>
Page last updated: 2014-11-30