Baclofen-Induced Manic Symptoms: Case Report And Systematic Review

Psychosomatics (Impact Factor: 1.86). 02/2014; DOI: 10.1016/j.psym.2014.02.003


The gamma amino-butyric acid type-B (GABA-B) receptor agonist baclofen is approved for spasticity and is used off-label for diverse types of addictive disorders, notably alcohol dependence. Baclofen may induce numerous neuropsychiatric adverse drug reactions (ADRs), including behavioural disinhibition. However, this precise ADR has never been assessed using either a validated causality algorithm or a scale for manic symptoms.

We report the case of a 49-year-old male patient who exhibited de novo mania during treatment with baclofen for alcohol dependence. Symptoms were evaluated using the Young mania rating scale (YMRS), and the causality of baclofen was determined using Naranjo’s algorithm. This case was also compared with other cases of baclofen-induced mania through a systematic literature review.

The patient, at 180 mg/d, presented with mania and scored 24/44 on the YMRS, and the imputability of baclofen was ‘probable’ using Naranjo’s algorithm (8/13). Four other cases of baclofen-induced mania were reported in the literature. Three cases had a bipolar I disorder history. Baclofen-induced manic symptoms (BIMSs) occurred mostly during the dose-escalation phase.

BIMSs may appear in patients with or without bipolar disorder. Particular attention is required during the dose-increase phase and in patients with a prior history of mood disorders.

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Available from: Pierre Alexis Geoffroy, Apr 23, 2014
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    • "Therefore, many participants in the survey, including HDB prescribers, reported some concerns regarding the management of the drug. This seems congruent with the increasing number of reports of previously known baclofen-induced ADRs as well as those of new ADRs that have been more recently described in the literature regarding the use of HDB in AUDs [20]–[24]. "
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    ABSTRACT: Objective To evaluate, among alcohol specialists belonging to the Société Française d’Alcoologie (SFA), i.e., the French Alcohol Society, the proportion of physicians who prescribed off-label baclofen for alcohol use disorders (AUDs). The secondary objective was to depict the features of individual prescribing and monitoring practices. Methods On-line survey among 484 French alcohol specialists. Physicians were asked whether they prescribed baclofen for AUDs. If they did not, the reasons for this choice were investigated. If they did, the features of the physician’s prescribing practice were explored, including the number of patients treated, the mean and maximum doses, the monitoring precautions and the pharmacovigilance reporting. Participants were also asked about their empirical findings on HDB’s efficacy and safety. Results In total, 302 physicians (response rate of 62.4%) participated in the survey. Data from 296 participants were analysed, representing 59.4% of all active prescribing physicians belonging to the SFA. HDB use was declared by 74.6% of participants (mean dose 109.5±43.6 mg/d; maximum dose 188±93.3 mg/d). However, 79.2% of prescribers had treated less than 30 patients, and 67.8% used HDB as a second-line medication. Although HDB was perceived as more efficacious than approved drugs by 54.3% of prescribers, it was also declared less safe by 62.8%. Nonetheless, 79.7% of prescribers had never filed any pharmacovigilance report. Non-prescribers (25.6%) were primarily deterred by the current lack of scientific data and official regulation. Conclusion A majority of French alcohol specialists reported using HDB, although often on a limited number of their patients. HDB was considered efficacious but also potentially hazardous. Despite this, physicians reported minimal safety data to the health security system. While French health authorities are planning to draft a specific regulatory measure for framing off-label HDB prescribing practices, the sustained education of prescribers on spontaneous pharmacovigilance reporting should be enhanced.
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