Symposium ProceedingsCharacterizing Baclofen Withdrawal: A National Survey of Physician Experience
Introduction
When baclofen, a medication commonly used for the treatment of spasticity, is abruptly discontinued a withdrawal syndrome can ensue. This syndrome typically progresses over 24 to 72 hours and can include an increase in muscle tone, status epilepticus, hallucinations, neuroleptic malignant syndrome-like response, severe hyperthermia, and multiorgan failure.1 Baclofen withdrawal can be difficult to diagnose because its nonspecific presentation is similar to sepsis, serotonin syndrome, and withdrawal from drugs of abuse.1,2 A warning for this syndrome is included in the package inserts of the oral and intrathecal (IT) formulations.3,4
Abrupt discontinuation of oral baclofen can occur when a patient is unable to take medications by mouth, might occur with impaired consciousness, gastrointestinal illness, emergency surgery, prolonged anesthesia, lack of access to the medication, or simple nonadherence. Oral baclofen withdrawal may be anticipated due to elective surgeries that are expected to result in a postoperative ileus. Abrupt discontinuation of IT baclofen most commonly occurs due to catheter displacement or breakage, and also when the reservoir is not refilled, the pump motor stalls, or there is battery failure.5,6 Abrupt discontinuation can also result following urgent removal of the baclofen pump due to infection of the pump pocket or catheter track. Approximately 24% to 38% of patients experience an IT pump or catheter complication during the time that they are on this therapy.5, 6, 7, 8, 9, 10, 11, 12 Although anticipated interruption of IT baclofen is rare, it can be due to a planned intervention following detection of infection or requested pump explantation due to dissatisfaction with therapy.
A variety of drugs are used to manage the symptoms of baclofen withdrawal, but these have limited efficacy and can cause adverse events.13,14 Whenever possible, immediate resumption of baclofen administration is attempted, although this is not always feasible. An intravenous (IV) formulation of baclofen is being developed to provide an alternate route of administration, which might help to prevent or manage baclofen withdrawal.13,15
There is little information regarding the actual occurrences, causes, and management of baclofen withdrawal. Furthermore, there are no established guidelines for its prevention or treatment. The objective of this survey was to collect physicians’ opinions concerning clinical concerns, perceived severity, occurrence, and management of baclofen withdrawal and the potential role of IV baclofen in this clinical syndrome.
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Methods
Approval of exempt status for this study was obtained from the University of Minnesota Institutional Review Board. Using REDCap, a secure web-based application, a pilot, 24-question survey was distributed via e-link to the pediatric rehabilitation and central nervous system subsections of the American Academy of Physical Medicine and Rehabilitation. Despite no offered incentive, 30 physicians provided anonymous responses to one or more questions. Following analysis of the pilot results, the
Patient and physician demographics
A total of 110 physicians (response rate = 11.6%) returned the completed survey. Physical medicine and rehabilitation specialists comprised the largest percentage of respondents (50%) followed by anesthesiologists (19.1%), neurosurgeons (17.3%), neurologists (9.1%), orthopedists (2.7%), and others (1.8%). Forty-seven percent of respondents have been practicing for more than 21 years. Sixty-seven percent and 49% of participants manage greater than 50 patients on oral and IT baclofen,
Discussion
As indicated by the years of practice, number of patients on oral and IT baclofen, and number of baclofen withdrawal episodes observed, the physicians who completed this survey are very experienced in the management of baclofen withdrawal.
Although all physicians were concerned about the potential for possibly severe withdrawal episodes, 75.7% do not have established protocols for anticipated interruption of oral baclofen and 36% do not have established protocols for anticipated interruption of
Conclusions
Baclofen withdrawal from both oral and IT therapy is recognized as a major concern and has been observed by most of our survey respondents. Many sites lack established management protocols, particularly for preventing withdrawal from oral baclofen. The absence of guidelines may contribute to a delay in treating the withdrawal syndrome resulting in suboptimal care. The results of this survey, along with a systematic literature review and multidisciplinary stakeholder input, could contribute to
Acknowledgments
The authors gratefully acknowledge the contribution of Medtronic, Inc, who identified participants and distributed our survey.
I am grateful for the mentoring, counseling, and friendship of Dr Kenneth (Ken) Swaiman, who encouraged me to pursue a career in academic medicine. Ken strongly supported my academic promotions. He also advised and helped with the review, editing, submission, and publication of my manuscripts. Robert (Bob) L. Kriel, M.D.
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Treatment of spasticity
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The results of this investigation have been presented in part at annual meetings of the American Congress of Rehabilitation Medicine in Atlanta, GA, 2017 and the Association of Academic Physiatry in San Juan, Puerto Rico, 2019.
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
There was no funding for this study.
Author Disclosures: Drs Coles, Krach, Kriel, and Schmitz have nothing to disclose. Dr Schrogie reports personal fees from Allaysis, LLC. during the conduct of the study and outside of the submitted work. In addition, Dr Schrogie has a patent pending for IV baclofen. Dr Cloyd reports that the University of Minnesota has a licensing agreement with Allaysis LLC. related to the development of IV baclofen and will receive royalty payments should IV baclofen be commercialized.