Baclofen Self-Poisoning in the Era of Changing Indication: Multicentric Reports to a French Poison Control Centre (original) (raw)

Baclofen and Alcohol-dependent Patients: A Real Risk of Severe Self-Poisoning

Basic & clinical pharmacology & toxicology, 2017

Baclofen is often prescribed in high doses to fight cravings experienced by alcohol-dependent patients. Such an increase in the availability of baclofen is concerning. This study aimed to determine the change in number and profile of self-poisoning with baclofen over time, since baclofen has become increasingly popular, in order to describe the severity of self-poisoning with baclofen and to focus on co-existing alcohol use disorders and psychiatric illnesses determine predictors of severity. This was a retrospective study of self-poisoning with baclofen as reported by the western France Poison Control Center (PCC), which represents a population of more than 12 million people from January 2008 to March 2014. 111 cases of self-poisoning with baclofen were reported to the western France PCC (62 males and 49 females; average age 39±12). Poisoning severities were: "null" (9 cases), "minor" (37 cases), "moderate" (19 cases) and "high" (46 cases, in...

High doses of Baclofen as suicide attempt in patients with alcohol use disorders – A serious concern

Asian Journal of Psychiatry, 2015

A c c e p t e d M a n u s c r i p t  Baclofen is often prescribed off-label in ADS patients who fail approved drugs.  Lack of proper recommendations on dosage has important safety implications.  Two patients reported had serious complications after acute self-inflicted overdose.  This includes CNS suppression, cardiac conduction and autonomic disturbances.  Benefit/risk should be assessed in all patients with co-morbid psychiatric disorder.

Risk of hospitalisation and death related to baclofen for alcohol use disorders: Comparison with nalmefene, acamprosate, and naltrexone in a cohort study of 165 334 patients between 2009 and 2015 in France

Pharmacoepidemiology and Drug Safety, 2018

Purpose: Baclofen is widely used off-label for alcohol use disorders (AUD) in France, despite its uncertain efficacy and safety, particularly at high doses. This study was designed to evaluate the safety of this off-label use compared to the main approved drugs for AUD (acamprosate, naltrexone, nalmefene). Methods: This cohort study from the French Health Insurance claims database included patients, aged 18 to 70 years, with no serious comorbidity (assessed by the Charlson score) initiating baclofen or approved drugs for AUD between 2009 and 2015. The risk of hospitalisation or death associated with baclofen, at variable doses over time (from low doses <30 mg/day to high doses ≥180 mg/day), compared to approved drugs, was evaluated by a Cox model adjusted to sociodemographic and medical characteristics. Results: The cohort included 165 334 patients, 47 614 of whom were exposed to baclofen. Patients exposed to baclofen differed from those treated with approved drugs in terms of sociodemographic and medical characteristics (more females, higher socioeconomic status, fewer hospitalisations for alcohol-related problems), but these differences tended to fade at higher doses of baclofen. Baclofen exposure was significantly associated with hospitalisation (hazard ratio [HR] = 1.13 [95%CI: 1.09-1.17]) and death (HR = 1.31 [95%CI: 1.08-1.60]). The risk increased with dose, reaching 1.46 [1.28-1.65] for hospitalisation and 2.27 [1.27-4.07] for death at high doses. Similar results were in patients with a history of hospitalisation for alcohol-related problems. Conclusions: This study raises concerns about the safety of baclofen for AUD, particularly at high doses, with higher risks of hospitalisation and mortality than approved drugs.

Baclofen overdose: Defining the spectrum of toxicity

Emergency Medicine Australasia, 2006

Objectives: To describe the spectrum of toxicity of baclofen in overdose, and investigate dose-related clinical effects. Methods: Consecutive baclofen overdoses were identified from a prospective database of all poisoning admissions presenting to a regional toxicology service. Ingestion was corroborated on more than one occasion and from multiple sources. Demographic, clinical and outcome variables were extracted for each presentation for a retrospective review, and the data sets were divided into high dose (≥ 200 mg) and low dose (< 200 mg) groups for comparison of clinical effects. Results: There were 23 presentations, of which eight patients ingested baclofen alone. Seizures were reported in four cases, a decreased level of consciousness (GCS < 9) occurred in eight patients and delirium was recorded in eight patients. Five patients had miosis and seven patients had dilated pupils, 13 patients had absent or depressed reflexes. The only arrhythmias were sinus bradycardia in six patients and sinus tachycardia in five. Hypertension occurred in 13 patients and hypotension in one. The reported total ingested dose of baclofen was known in 19 patients (Mean 630 mg, SD 730 mg; 80-2500 mg). A higher ICU admission rate, rate of mechanical ventilation and prolonged length of stay occurred in those ingesting 200 mg or more. Coma, delirium and seizures occurred only with doses of 200 mg or more, and hypertension was more common with higher doses. Conclusions: Baclofen overdose causes mainly neurological effects and excepting hypertension cardiovascular effects were uncommon. Doses greater than 200 mg were predictive of patients developing delirium, coma and seizures, requiring long hospital admissions and ICU admission.

A prescription guide for baclofen in Alcohol Use Disorder- For use by physicians and patients

Journal of Addiction Medicine and Therapeutic Science, 2017

Since the discovery by Olivier Ameisen that high-dose baclofen can produce a state of indifference towards alcohol in those with Alcohol Use Disorders (AUD), the prescription of baclofen in AUD patients has exponentially increased. There are currently hundreds of thousands of patients with AUD who benefi t from this treatment in France. However, the prescription of baclofen is diffi cult in many ways. First, the treatment, which consists in a slow progressive increase of doses, must be individually adapted, some patients needing low doses to achieve a state of indifference, while others need high or very high doses. Second, baclofen produces many adverse effects that can be very uncomfortable for patients, and may sometimes be dangerous. The third is that the patients must be strongly engaged in the management of the treatment, as they are the ones who will have to fi nd the best way to target the moments of cravings and determine the distribution of the doses over the day to limit the occurrence of adverse effects. The doctor: patient therapeutic alliance is therefore a crucial element in the management of baclofen treatment. The present article is a guide written by both doctors and cured patients ("expert patients") for the prescription of baclofen in AUD.

Clinical Experience with Baclofen in the Management of Alcohol-Dependent Patients with Psychiatric Comorbidity: A Selected Case Series

Alcohol and Alcoholism, 2011

Aims: To illustrate the potential indications for, and adverse effects of, baclofen pharmacotherapy for alcohol dependence in patients with co-existing psychiatric illness. Methods: Audit of the files of alcohol-dependent patients treated for comorbid non-psychotic psychiatric illness in a specialist detoxification unit with integrated outpatient treatment. Files were selected of patients who had been offered treatment with baclofen because other alcohol pharmacotherapies had previously been unsuccessful in preventing relapse or were contraindicated. Results: Of the 21 selected patients, 13 attended for outpatient treatment, with follow-up periods ranging from 4 days to 27 months, and the outcomes could be rated. Prescribed baclofen doses ranged from 30 to 275 mg daily. Common side effects at lower doses included tiredness and sedation; one patient on 120 mg/day developed reversible severe back pain, and a patient taking up to 275 mg/day developed somnolence, dizziness and incontinence. Seven patients maintained significant periods of abstinence, and one patient reduced daily consumption to non-problematic levels. Two patients consumed an overdose of other central nervous system (CNS) depressants, while taking baclofen in the first week of treatment, were briefly unwell, were given emergency monitoring, but made a full recovery. Conclusion: While more than half the patients reported significant reduction in alcohol use, it is not possible to draw definite conclusions about the effectiveness of baclofen, given that it was combined with other psychiatric and alcohol treatments, and because there was no control or comparison group. We recommend caution when offering baclofen to patients with a history of recurrent overdosing or a history of other substance misuse. When prescribing in conjunction with other medications with CNS depressant action, close monitoring is recommended at initiation and during dose escalation. PATIENTS AND METHODS All patients described in this case series required admission to a 15-bed inpatient withdrawal ('detoxification') unit, which provides a Statewide service for patients with a comprehensive range of substance use disorders.

An intoxication mimicking brain death: baclofen

Acta Neurologica Belgica, 2018

Baclofen is a derivative of gamma-aminobutyric acid, used mainly for the treatment of muscle spasticity. Baclofen overdose can result in severe respiratory depression, autonomic disturbances, seizures and coma. Here we report a 15-year-old girl who was found unresponsive, intubated and admitted to the PICU. On initial presentation, her Glasgow Coma Score was 3, with fixed dilated pupils. EEG revealed cerebral bioelectric activity and ground amplitudes significantly lower than normal. Supportive treatments were administered. On the 2nd PICU day, she regained consciousness and was able to follow commands. She was extubated and discharged on hospital day 3. Conclusively emergency physicians should consider baclofen overdose in children presenting with acute loss of consciousness, flaccidity, and hyporeflexia.

Correlation between the single, high dose of ingested baclofen and clinical symptoms

Annals of Agricultural and Environmental Medicine, 2017

Introduction and Objectives. Baclofen is a drug used mainly to treat muscle spasticity. Its overdose can lead to lifethreatening clinical symptoms, including acute respiratory failure requiring mechanical ventilation. The aim of this study was to assess the prevalence of selected clinical symptoms associated with baclofen poisoning comparing to an ingested dose. Materials and method. 60 cases of oral baclofen poisoning were analyzed. Gender, age distribution, and correlation between the dose of ingested baclofen were studied, as well as and following clinical parameters: degree of altered consciousness, heart rate, blood pressure, presence of acute respiratory failure, duration of mechanical ventilation, and presence of psychotic symptoms. Results. The study found statistically significant correlations between dosage of ingested baclofen and presence of acute respiratory failure, as well as duration of mechanical ventilation. No statistically significant correlations were found between the dose of ingested baclofen and presence of hypertension, bradycardia, acute psychotic symptoms, or level of consciousness disturbance. However, it was found that patients who suffered from hypertension, bradycardia, and altered mental status ingested a larger dose of baclofen. Conclusions. There is a statistically significant correlation between the dose of ingested baclofen and the presence of acute respiratory failure, and duration of mechanical ventilation. Patients who have taken a single dose of baclofen of 200 mg, or higher, should be managed in centres able to provide continuous monitoring of life functions. Those with a higher level of a single dose of baclofen ingestion (>500 mg), should be hospitalized in a Toxicology Unit or Intensive Care Unit able to provide airway support and mechanical ventilation.

Accidental Intoxication with 60 mg Intrathecal Baclofen: Survived

Neurocritical Care, 2012

Background Intrathecal baclofen (ITB) is an effective and well-tolerated treatment for patients with severe spasticity. Intoxications are rare and usually iatrogenic, with reported intrathecal boluses varying between 0.050 and 30 mg. Methods We here report the case of a 47-year-old woman with severe spastic paraplegia due to multiple sclerosis who, during a routine filling procedure, accidentally received a bolus of 60 mg ITB because of injection into the side-port instead of the reservoir of her ITB pump (Archimedes Ò , Codman, Germany). Results After a short period of dizziness, she lost consciousness and stopped breathing. She was immediately intubated, mechanically ventilated, and admitted to the intensive care unit. As specific treatment, she received cerebrospinal fluid drainage through a newly implanted lumbar catheter. A series of generalized and complex partial seizures were treated with levetiracetam and lacosamide. Acute autonomic dysfunction with episodic arterial hypo-and hypertensions was controlled by catecholamines and clonidine, respectively. Recurrent hyperthermia, however, responded neither to drugs nor to physical treatment. After 3 weeks, the patient was discharged without any relevant new neurologic signs or symptoms. Conclusions This case demonstrates that even excessive doses of ITB can let the patients survive without sequelae if treated promptly and offensively. A pertinent problem during detoxification is the question of when to restart ITB to avoid drug withdrawal.