Psychosis with use of amphetamine drugs, methylphenidate and atomoxetine in adolescent and adults.

Background: Use of psychostimulants and relative drugs has increased worldwide in treatment of attention-deficit hyperactivity disorder (ADHD) in adolescents and adults. Recent studies suggest a potential association between use of psychostimulants and psychotic symptoms. The risk may not be the same between different psychostimulants.

Teaching pharmacovigilance to French medical students during the COVID-19 pandemic: Interest of distance learning clinical reasoning sessions.

Background: Considering data from the literature in favor of active educational intervention to teach pharmacovigilance, we describe an innovative model of distance learning clinical reasoning sessions (CRS) of pharmacovigilance with 3rd year medical French students.

Methods: The three main objectives were to identify the elements necessary for the diagnosis of an adverse drug reaction, report an adverse drug reaction and perform drug causality assessment. The training was organized in 3 stages.

Extreme hydrological regimes of a small urban river: impact on trace element partitioning, enrichment and fluxes.

The input of trace elements from a small urban river (Las River, Toulon, France) located on the northern Mediterranean coast was studied during both base flow and flood events. A 2-year monitoring period of water flow and suspended particulate matter (SPM) showed a typical Mediterranean hydrological regime: a strong increase in water flow and SPM during short flood periods. During the flood event, an up to 2-fold increase in dissolved trace element (D) concentrations and particulate trace element content in SPM (P) was observed compared to the baseline discharge.

Optimizing therapeutic decision-making for off-label medicines use: A scoping review and consensus recommendations for improving practice and research.

Purpose: Off-label medicines use is a common and sometimes necessary practice in many populations, with important clinical, ethical and financial consequences, including potential unintended harm or lack of effectiveness. No internationally recognized guidelines exist to aid decision-makers in applying research evidence to inform off-label medicines use. We aimed to critically evaluate current evidence informing decision-making for off-label use and to develop consensus recommendations to improve future practice and research.

Weight Gain During Antipsychotic Treatment in Children, Adolescents, and Adults: A Disproportionality Analysis in the Global Pharmacovigilance Database, Vigibase.

Introduction: While antipsychotic-induced weight gain has been widely described in adults, it has yet to be better characterized in children and adolescents.

Objective: The aim of this study was to assess antipsychotic-induced weight-gain reporting in children and adolescents as compared to adults, and according to the type of antipsychotic.

Methods: The study is an observational, case-non-case study using individual case safety reports from the WHO global pharmacovigilance database VigiBase from 1 January 2000 to 2 June 2021.

COVID-19 vaccines: A perspective from social pharmacology.

Social pharmacology is a branch of clinical pharmacology, which depicts relationships between society and drugs and in particular factors, reasons, social consequences of drug use as well as representations of drugs in the society. Recent development and marketing of coronavirus disease 2019 (COVID-19) vaccines raises a number of questions of social pharmacology: are vaccines drugs like any other? What is their perception at the individual, population and societal levels? How do individuals perceive the risks and benefits of these vaccines? What is the perception at the societal level? What is the individual and societal acceptability of these vaccines during a pandemic? All these questions are discussed in the light of recent data. A number of proposals, both at the individual and at the collective or population level, are formulated to help solve these problems of social pharmacology.

Fatal adverse drug reactions: A worldwide perspective in the World Health Organization pharmacovigilance database.

Aims: Adverse drug reactions (ADRs) are important causes of death. However, the main involved drugs are relatively unknown. The present study was performed to characterise death-related drugs recorded in a large pharmacovigilance database during the last 10 years.

Trace Metal Contamination Impacts Predicted Functions More Than Structure of Marine Prokaryotic Biofilm Communities in an Anthropized Coastal Area.

Trace metal (TM) contamination in marine coastal areas is a worldwide threat for aquatic communities. However, little is known about the influence of a multi-chemical contamination on both marine biofilm communities' structure and functioning. To determine how TM contamination potentially impacted microbial biofilms' structure and their functions, polycarbonate (PC) plates were immerged in both surface and bottom of the seawater column, at five sites, along strong TM contamination gradients, in Toulon Bay.

Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns.

Objectives: In recent clinical trials some cardiac arrhythmias were reported with use of remdesivir for COVID-19. To address this safety concern, we investigated whether use of remdesivir for COVID-19 is associated with an increased risk of bradycardia.

Methods: Using VigiBase®, the World Health Organization Global Individual Case Safety Reports database, we compared the cases of bradycardia reported in COVID-19 patients exposed to remdesivir with those reported in COVID-19 patients exposed to hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids.

Drug-Induced Hearing Loss in Children: An Analysis of Spontaneous Reports in the French PharmacoVigilance Database.

Introduction: Hearing loss can have a negative impact on communication, with significant vocational, educational, and social consequences. Drugs are one of the causes of hearing loss in children.

Objectives: The objective of our study was to describe drug-induced hearing loss in the pediatric population.

Amiodarone and Parkinsonism: a pharmacovigilance study.

Background: Some case reports have described parkinsonism with amiodarone. We investigated a putative association between parkinsonism and exposure to amiodarone.

Methods: We used the WHO pharmacovigilance database (VigiBase ).

Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019.

Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2. Recently, the Food and Drug Agency (FDA) and the European Medicines Agency (EMA) recommended remdesivir for the treatment of patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection. In the remdesivir clinical development program, some cases have raised concerns regarding potential hepatobiliary disorders associated with remdesivir, including in healthy volunteers and patients with COVID-19.

Can tramadol really induce hyponatraemia? A pharmacovigilance study.

Several papers have described hyponatraemia with tramadol. However, in most reports, several confounding factors can be found. We used the WHO pharmacovigilance database (VigiBase®) to investigate if tramadol alone could be associated with hyponatraemia.

Neurological Adverse Effects Associated With Anti-tumor Necrosis Factor Alpha Antibodies in Pediatric Inflammatory Bowel Diseases.

Objectives: Neurological adverse effects (NAEs) induced by biotherapies have been reported in the literature mainly in adult patients with inflammatory bowel disease (IBD), rheumatic diseases, or psoriasis. There are scant data in children. Aims of this study are to report and describe noninfective NAE associated with anti-TNFα antibodies in pediatric IBD, and to evaluate their incidence.

Interest of a general practitioner pharmacovigilance network to provide drug information: A comparative study in France.

Introduction: Since 2015, Toulouse University PharmacoVigilance Center (TUPVC) set up a pharmacovigilance (PV) general practitioner (GP) network, called PharmacoMIP-MG. A clinical research assistant (CRA) moves to the office of GPs included in the PharmacoMIP-MG network (PMIP-GPs). There, he collects the adverse drug reaction (ADR) reports and drug-related questions.

Impacts of copper and lead exposure on prokaryotic communities from contaminated contrasted coastal seawaters: the influence of previous metal exposure.

Our understanding of environmental factors controlling prokaryotic community is largely hampered by the large environmental variability across spatial scales (e.g. trace metal contamination, nutrient enrichment and physicochemical variations) and the broad diversity of bacterial pre-exposure to environmental factors.