Self-poisoning with baclofen in alcohol-dependent patients: national reports to French Poison Control Centers, 2008-2013.

BACKGROUND: Alcohol use disorders are frequently associated with self-intoxication in attempted suicide. In France since 2008, the off-label use of baclofen for treatment of alcohol dependence has greatly increased, leading to temporary regulation of use of the drug. At the request of the national authorities, the French Poison Control Centers carried out a retrospective survey to give an overview of baclofen exposure in this population. METHODS: A retrospective study was carried out from January 2008 to December 2013, focusing on baclofen exposures in alcohol-dependent patients managed by the nine national French Poison Control Centers. RESULTS: 294 observations of baclofen exposures in alcohol-dependent patients were identified in our database. Of these, 220 were suicide attempts by self-poisoning and 74 were unintentional. The mean age of patients was 41.7 years, with a sex-ratio of 1.6. Patients attempting suicide with baclofen were younger than those with unintentional exposures, and 43.6% of them were women (vs 22.9%, p < 0.01). The mean supposed ingested dose was higher (480.7 mg) in patients who attempted suicide (vs 192.5 mg, p < 0.0001). 21.8% of intentional exposures involved baclofen alone. Psychiatric comorbidity (50.4%) was more frequent in the group of self-poisoning (p < 0.001). 132 patients were coded as severely exposed (60.0%). Nine victims died, but the causal link between self-poisoning with baclofen and fatal outcome should be interpreted with particular caution. CONCLUSIONS: Baclofen self-poisoning by alcohol-dependent patients is a serious concern for the French health authorities. Our results are similar to those previously published, suggesting that most patients with baclofen overdose should be admitted to an intermediate or intensive care unit as the clinical course requires close monitoring. Because suicidal ideation and suicide attempts are more prevalent in people with substance use disorders than in the general population, and because of the lack of recommendations governing baclofen prescription in such a situation, its use needs to be better controlled.

Child poisonings with methadone in France: A 6-year prospective national survey since the availability of capsules in 2008.

BACKGROUND: Methadone for opiate substitution was available only in syrup formulation prior to 2008. In 2007, the French Health Authorities made solid forms available. A national survey was performed in order to evaluate the modification of child poisonings induced by such a new pharmaceutical formulation. METHODS: A prospective study was set up (April 15, 2008 to April 15, 2014) with the analysis of cases of unintentional ingestion of methadone by patients under 18 years old and managed by the 10 French poison control centers at the national level. As soon as a new pediatric exposure was recorded in the informatics data bank of the Poison Centers, a telephone survey was performed by the Marseilles' Poison Center to obtain the evolution and all the necessary details. RESULTS: 87 cases of child poisonings with the 2 forms were reviewed (syrup, 56 patients; capsules, 31 patients). Comparison shows that patients were similar for both formulations (no significant difference concerning age [median 2 years], sex ratio [M/F 0.85], previous history, and ingested quantities of methadone). There was a similar severity profile with both formulations proving that methadone can lead to lethal child intoxications (1 death with capsules and 4 with syrup). The relative risk of pediatric accidents is also the same with 2 formulations, leading the health authorities, in collaboration with laboratories, to design and distribute flyers. The aim was to inform patients who are also parents about the high danger risk of their treatment for children, whatever the formulation of methadone present in the house. DISCUSSION: The results of this survey were similar to those of another national study by the French Poison Centers concerning adult suicide attempts with methadone. Both prospective studies led to the conclusion that methadone must be considered as a dangerous molecule for patients and their families. The recent availability of a solid formulation in France did not change the profile of poisonings with this opiate substitute treatment.

[Pharmacovigilance and medication errors]. / Pharmacovigilance et erreurs médicamenteuses, le rôle primordial de la déclaration.

The French national agency for the safety of medicine and healthcare products created in 2005 a Medication Errors Desk which enables health professionals and patients to report directly medication errors without adverse reaction or near misses in addition of reports collected from the Pharmacovigilance System.