Therapie最新文献

Objectives: Behavioral addictions (BA) are a newly recognized diagnostic entity. While some drugs are known to induce BA, some of them remains unknown. The aim of this study was to identify drugs for which B is not listed in the summaries of product characteristics.

Methods: We conducted a search on Vigibase to identify health professional's cases where drugs are "suspect" coded with the following preferred terms: (1) 'behavioral addiction', (2) 'gambling disorder', (3) 'gaming disorder', (4) 'compulsive sexual behavior', (5) 'bulimia nervosa', (6) 'binge eating' and (7) 'compulsive shopping'. We selected drugs "suspect" in at least five cases for which the summaries of product characteristics do not mention BA. We applied a downward descriptive process (drug only suspect, positive dechallenge, well-documented cases) together with a disproportionality analysis and a PubMed search.

Results: We identified 24 drugs across 7 pharmacological classes: antidepressants, antipsychotics, antiepileptics, benzodiazepines, psychostimulants, antidiabetics and retinoids. Olanzapine was the only accompanied by well-documented cases with positive dechallenges, exhibiting significant disproportionality analysis and associated with publications from the PubMed search.

Conclusion: Our results highlights that several drugs and notably olanzapine are associated with BA. Further research using definitions enabling the diagnosis of addictive disorders for various BA is warranted.

Here we describe the implementation of a new tool that would allow to assess the risk of serious disability following in utero exposure to medications. The overall objective was to enrich the EFEMERIS database [Évaluation chez la Femme Enceinte des MEdicaments et de leurs RISques (evaluation in the pregnant woman of medications and their risques database] containing data on reimbursed medication prescriptions and pregnancy outcomes) with data from the Haute-Garonne childhood disability registry (RHE31). The EFEMERIS database included 97,350 children born between 2004 and 2014 who were still living in Haute-Garonne at the age of 8. After matching with the RHE31, we identified 908 children (58.8% of RHE31-eligible children) with pervasive developmental disorder (PDD)/autism spectrum disorder (ASD) and/or severe motor impairment, severe neurosensory impairment or intellectual disability (IQ<50). Non-matched RHE31-eligible children did not differ significantly from matched children. Children diagnosed with PDD/ASD and/or severe disability were significantly more likely to have been exposed to certain ATC drug classes, particularly those in the "nervous system" class. Given the number of RHE31-children included, we can already envisage pharmacoepidemiologic studies to investigate the relationship between in utero medication exposure and the child's risk of neurodevelopmental disorders. This project, the first of its kind in France, will specifically improve data on the effects of medications on child neurodevelopment.

Introduction: In France, the consumption of benzodiazepines (BZD) remains significant despite Haute autorité de santé (French National Authority of Health-HAS) recommendations. Various strategies are recommended: gradual dosage reduction of the BZD consumed or switch to diazepam in certain situations. Prazepam may also be an interesting molecule (long half-life, oral solution, less risk of abuse than diazepam). The aim of this study is to describe the efficacy, adverse events and feasibility of a BZD withdrawal program with prazepam.

Materials and methods: Data were collected retrospectively among patients hospitalized at the Saint Barnabé clinic in 2022, which had a prescription of prazepam for withdrawal purposes. Withdrawal was considered successful at discharge if the initial prazepam dosage was reduced by more than 50 %, or if prazepam was stopped.

Results: Most of the 86 patients had psychiatric or addictive comorbidities. Among them, 55 % had been using BZDs for over a year, 36 % consumed at least two BZDs, and 15 % took doses exceeding authorized indications. At discharge (median of 42 days), 29 % of patients were fully withdrawn, and 33 % had reduced their initial prazepam dosage by more than 50 %. The protocol was adapted in 38 % of patients, and 27 % experienced withdrawal symptoms. Several factors were significantly associated with partially successful or no success: presence of personality disorder, hospitalization in a context of cocaine use disorder, signs of withdrawal and protocol adaptation.

Discussion: This study highlights the utility of prazepam in BZD withdrawal among a population at high risk for complicated withdrawal. The occurrence of clinical symptoms and protocol adjustments emphasize the importance of individualized management with regular medical reassessment.

Objectives: Despite the widespread use of fluorinated medicines - with approximately 20% of the drugs marketed in 2020 containing fluoride compounds - the association between these medications and fluorosis remains under-recognized. This study aimed to identify medications most likely to induce fluorosis in real-world clinical settings using pharmacovigilance databases.

Methods: A descriptive and disproportionality study was conducted using French national (FPVB) and international pharmacovigilance databases (VigiBase®). Cases of fluorosis were extracted from Vigibase® up to July 8, 2024, using the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "fluorosis", "fluoride increased" and "fluorosis dental". French cases were subsequently extracted from the FPVB. Disproportionality signals were evaluated by calculating the reporting odds ratio (ROR) and corresponding 95% confidence interval (CI).

Results: A total of 72 cases of suspected drug-induced fluorosis were identified in VigiBase®. The most frequently reported adverse effects were musculoskeletal disorders (n=39, 54.2%), dental disorders (n=11, 15.3%), and eyes and visual disorders (n=8, 11.1%). Two-third of the cases (n=52) were classified as serious. In 40% of cases (n=29), the outcome was favorable. Voriconazole, sodium fluoride, fluconazole and ciprofloxacin were identified as single suspects. Disproportionality signals were detected for sodium fluoride (ROR=2305.7; 95% CI [1143.9; 4647.3]), voriconazole (ROR=1415.4; 95% CI [891.5; 2247.3]), fluconazole (ROR=110.4; 95% CI [52.9; 230.3]), fludarabine (ROR=87.3; 95% CI [31.8; 239.3]) and ciprofloxacin (ROR=7.1; 95% CI [2.2; 22.4]). The 16 cases from the FPVB provided more detailed information, including the clinical context - mainly hematological malignancies (37.5%) and organ transplants (12.5%) - the median time to onset (361 days), mean plasma fluoride concentration (1.33mg/L; range 0.006-7.2mg/L), and results imaging explorations.

Conclusion: This study highlights pharmacovigilance signals suggesting a potential association between fluorosis and certain fluorinated compounds, particularly sodium fluoride, voriconazole, fluconazole, fludarabine and ciprofloxacin. Among these, only sodium fluoride and voriconazole include fluorosis in the summary of product characteristics. Clinicians should remain vigilant regarding this potential adverse drug reaction, especially with long-term use of these medications.