Johana Béné

Centre Hospitalier Régional Universitaire de Lille · Division of Medical Pharmacology

Immune checkpoint inhibitor (ICI)-related cytopenias have been poorly described. This study aimed to further characterize ICI-related cytopenias, using the French pharmacovigilance database. All grade ≥ 2 hematological adverse drug reactions involving at least one ICI coded as suspected or interacting drug according to the World Health Organization...

Résumé L’éthanol est un excipient à effet notoire dont la présence est réglementée car il peut causer des effets indésirables, et notamment l’apparition de mésusage. Afin de sensibiliser à ce risque, cette étude a recherché les médicaments destinés à la voie orale contenant de l’éthanol en tant qu’excipient depuis la base de données Thériaque®. Les...

Introduction Le protoxyde d’azote est détourné et mésusé depuis plusieurs années, à bas bruit, dans certains milieux liés à la musique ou étudiants. Depuis la fin 2018 son mésusage dans les Hauts-de-France est à l’origine d’un nombre croissant de signaux. Les caractéristiques du mésusage, ses complications et son évolution seront décrits. Méthodes...

A better understanding of immune-related adverse events is essential for the early detection and appropriate management of these phenomena. We conducted an observational study of cases recorded at the French reference center for hypereosinophilic syndromes and in the French national pharmacovigilance database. Thirty-seven reports of eosinophilia i...

Background: Several clusters of encephalopathy occurred after the market change from Holoxan® (ifosfamide lyophilized powder) to Ifosfamide EG® (liquid formulation) and justified a formal survey in 2015. In June 2016, the regulatory authority decided to apply a precautionary measure in reducing the shelf life of Ifosfamide EG® at 7 months. One-yea...

Many risk factors are known to induce or precipitate dementia. Drugs acting via different mechanisms can modulate cognitive performance and exert either beneficial or deleterious effects on cognition through functional or neuropathological mechanisms. This review discusses the association between several classes of drugs and cognitive impairment an...

Background: The French nationwide exhaustive hospital discharge database (PMSI) is used for activity-based payment of hospital services. We hypothesized that the release of articles about alcohol and dementia could influence the identification of these diagnoses in PMSI. Methods: We analyzed temporal evolution of coding for dementia and other pe...

Société Française de Pharmacologie et de Thérapeutique (Toulouse)

Isolated arthralgia, without hemorrhagic side effect exists and is considered as a very rare adverse drug reaction according to vitamin K antagonists’ (VKAs) summary of product characteristics. Up to now, there are no literature reports of isolated, non‐hemorrhagic joint complications in patients receiving VKAs. Hence, the objective of this study w...

Résumé Introduction Le déficit androgénique lié à l’âge (DALA) est une pathologie de plus en plus citée dans les publications récentes. Le surrisque cardiovasculaire de la testostérone fait débat : présent pour la FDA, absent pour l’Agence européenne du médicament en 2015. Notre objectif était d’analyser l’association entre androgènes et pathologi...

Background: Etoposide phosphate (EP; single injection, 60 mg/kg) followed by total body irradiation (TBI) at 12 Gy has been used as an allogeneic stem cell transplantation (allo-SCT) conditioning regimen for children since 2010. In our institution, EP has been suspected of leading to acute nephrotoxicity. The aim of this study was to assess the po...

Résumé Objectif La plupart des antidépresseurs ont été associés à une hyponatrémie dans la littérature. Cet effet indésirable n’est pas toujours rapporté dans les monographies. L’objectif de notre étude était de clarifier la différence d’augmentation de risque d’hyponatrémie parmi les différents antidépresseurs. Méthode Étude rétrospective de typ...

While physicians increasingly recognize nicorandil-related mucocutaneous ulcerations, there are still misdiagnoses, particularly in the case of unusual location and late onset ulceration after nicorandil introduction. The goal of our study was to remind clinicians about the link between nicorandil use and the development of cutaneous ulcerations an...

Key message Additional data suggesting that rivaroxaban does not seem to be efficient in all APS patients.

Les anticoagulants oraux représentent la principale cause d’hospitalisation pour iatrogénie en France, alors qu’ils sont sous-prescrits. Les recommandations préconisent l’utilisation du score HAS-BLED pour évaluer le risque hémorragique lié à ces traitements.

Résumé But L’objectif de cette étude était d’analyser les effets indésirables déclarés avec l’implant d’étonogestrel (Implanon® puis Nexplanon®) en France. Matériel et méthodes Tous les cas d’effets indésirables déclarés aux autorités de santé ou à la firme ont été analysés. Résultats En 10 ans, 789 grossesses et 5433 effets indésirables ont été...

Objectives: Observational retrospective studies have linked domperidone and prolonged QT interval, ventricular arrhythmias and risk of sudden death. Since then, antiemetic prescription was applied to other molecules (including metopimazine). The aim of this study was to evaluate the profile of adverse cardiac effects associated with QT prolongatio...

Rationale Resistant cytomegalovirus-mediated infections are increasing in solid organ recipient with few available alternative treatments. Brincidofovir is an oral broad-spectrum antiviral in development for prevention and treatment of viral infection, particularly cytomegalovirus. Patients concerns Although brincidofovir is an analogue of cidofov...

Pendant plus de six décennies, les antivitamines K (AVK) ont été la seule classe d’anticoagulants oraux disponibles sur le marché. L’arrivée des Anticoagulants Oraux Directs (AOD) en 2008 a marqué un réel tournant dans l’anticoagulation par voie orale. La première partie de ce travail s’est intéressée aux caractéristiques des patients traités par a...

The default for the Commenting tool bar is set to 'off' in version 9. To change this setting select 'Edit | Preferences', then 'Documents' (at left under 'Categories'), then select the option 'Never' for 'PDF/A View Mode'. (Changing the default setting, Adobe version 9) To make annotations in the PDF file, open the PDF file using Adobe Reader XI, c...

Objectives: The aim of the study was to assess the incidence of adverse effects (AE) reported with etonogestrel contraceptive implant in France (Implanon(®) and Nexplanon(®)). Materials and methods: All cases of AE or unintended pregnancies reported to health authorities or to the firm were analyzed. Results: During 10 years, 5433 AE and 789 u...

Background: Inhibitors of DiPeptidyl Peptidase-IV (DPP-IV) have been suspected in the onset of bullous pemphigoid for several years now, however comparative studies assessing the link between DPP-IV inhibitor exposure and bullous pemphigoid have not yet been performed. Objective: To detect, from the French Pharmacovigilance Database (FPVD), a si...

We posted the Nord-Pas-de-Calais regional pharmacovigilance center website and distributed a survey to its potential users between August 2014 and October 2014 (135 general practitioners, 45 pharmacists, 14 patients). Satisfaction was 7.3±1.6 out of 10 points for the visual aspect, 7.8±1.5 out of 10 points for navigation and 7.6±1.4 out of 10 point...

Introduction Les complications hémorragiques des antivitamines K (AVK) se révèlent souvent par des hémarthroses ou des hématomes. Des manifestations articulaires non hémorragiques sous AVK sont néanmoins signalées. Patients et méthodes Notre objectif était de décrire ces manifestations articulaires à partir des observations identifiées dans la bas...

Introduction Depuis plusieurs années, les inhibiteurs de la DiPeptidyl Peptidase-IV (DPP-IV) ont été suspectés dans la survenue de cas de pemphigoïdes bulleuses. Cependant, aucune étude comparative n’a à ce jour été menée pour étudier le lien de causalité entre exposition aux inhibiteurs de la DPP-4 et survenue de pemphigoïdes bulleuses. L’objectif...

In 2012, in France, phenytoin sodium was used as a substitute for phenytoin base during a shortage at the dose of 100 mg for 100 mg, according to the French Health Agency recommendations. However, this substitution was problematic because the two specialties were not bioequivalent. We report here the case of a 29-year old woman who presented with s...

Background: Community pharmacists' liability is involved when they dispense off-label prescriptions (OLPs). However, their attitudes to off-label prescribing are little known, while in France off-label baclofen use for alcohol dependence is increasing. Objective: To determine community pharmacists' attitudes to off-label prescribing of baclofen....

Patients treated with clozapine show autonomic dysregulation and cardiac repolarisation changes. As clozapine crosses the placenta, it could have an impact on the fetus heart rate. We reported a case of reduction of the fetal heart rate variability in a patient treated with clozapine during her pregnancy. This anomaly disappeared with fetal maturat...

We report the case of a woman treated with adalimumab and mesalazine for a Crohn's disease who presented 9 years after the beginning of the treatments an interstitial lung disease (ILD) discovered by chance during a routine medical examination. Several hypotheses were evocated: progression of the Crohn's disease with a pulmonary involvement then th...

A young girl aged 13-years-old treated with montelukast, fluticasone/salmeterol, desloratadine, fluticasone furoate and salbutamol has presented numerous spontaneous bruises after that treatment with montelukast was substituted by the generic form. Stopping montelukast allow a significant improvement in bruises. © 2014 Société Française de Pharmaco...

Background Romiplostim and eltrombopag, the two marketed thrombopoietin receptor agonists (TPO-RAs), have distinct binding sites and might have distinct pharmacodynamic mechanisms. The aim of this study was to compare their adverse drug reaction (ADR) patterns. Methods We selected in the French PharmacoVigilance Database all ADRs associated with T...

We report a case of weight gain induced by thalidomide in a 39-year-old female patient with Behçet's disease treated for an indication of severe, bipolar, aphthous stomatitis. © 2014 Société Française de Pharmacologie et de Thérapeutique.

Aim: To identify, in a case-control study, the risk factors associated with a thrombotic or bleeding event in patients treated with vitamin K antagonists. Materials and methods: We performed a single-centre observational study during a three-month period where we consecutively included patients admitted to the emergency department of a secondary...

To report three cases of bullous pemphigoid in patients treated with vildagliptin. Case 1: An 86-year-old woman presented with bullous pemphigoid after one month of treatment with vildagliptin and metformin. After introduction of clobetasol the symptoms resolved although vildagliptin was continued. However, the skin lesions reappeared three months...

Depuis 25 ans, on connaît l’interaction du pamplemousse avec diverses molécules, estimées désormais à plus de 85. Les mécanismes en cause passent par une interaction avec la métabolisation intestinale des médicaments par les cytochromes P450 et par une interaction avec certains transporteurs membranaires intestinaux des médicaments. Les conséquence...

Objectives: The aim of this research was to describe the cases of TNF-α antagonist-related alopecia reported in the French Pharmacovigilance Database (FPVD) and to investigate the association between exposure to TNF-α antagonists and occurrence of alopecia. Methods: All spontaneous reports of TNF-α antagonist-related alopecia recorded in the FPV...

Desmopressin is a synthetic vasopressin analog that increases the plasma levels of coagulation factor VIII, von Willebrand factor, and tissue plasminogen activator. This hemostatic agent, which can be administered either parenterally or intranasally, has been approved for use in the prevention and treatment of hemorrhagic events during surgery in p...

Objectives. The aim of this research was to describe the cases of TNF-a antagonist-related alopecia reported in the French Pharmacovigilance Database (FPVD) and to investigate the association between exposure to TNF-a antagonists and occurrence of alopecia. Methods. All spontaneous reports of TNF-a antagonist-related alopecia recorded in the FPVD b...

The risk of malignancies on TNF-α antagonists is controversial. The aim of this survey was to assess cancer risk on TNF-α antagonists in adult rheumatoid arthritis patients, including the five marketed drugs (infliximab, etanercept, adalimumab, golimumab and certolizumab) used in line with the New Drug Application. Furthermore, the relative interes...

Trials excluded at the second step of the selection process. (DOC)