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Sylvie Favrelière, Claire Lafay-Chebassier, Bernard Fauconneau, Alexandre Quillet, Mélissa Yéléhé-Okouma, François Montastruc, Marie-Christine Pérault-Pochat
INTRODUCTION: Nalmefene, an opioid antagonist, causes withdrawal syndromes in patients exposed to an opioid agonist. Despite its contraindication, this illogical drug association persists, especially with opioid substitution drugs (ODS). We measured the benefits of the modification in the summary of product characteristics (SPC) in March 2015 and the package leaflet of Selincro® in September 2016 on this misuse. MATERIAL AND METHOD: We analyzed the observations regarding a use of nalmefene with an opioid between September 2014 and August 2017 in the French pharmacovigilance database and the laboratory...
August 3, 2018: Thérapie
Marie Baumevieille, Joëlle Perri-Plandé, Ghada Miremont-Salamé, Amélie Daveluy, Françoise Haramburu
Addictovigilance in the French Public Health Code, in the section related to poisonous substances, refers to a monitoring system developed since 1990: control of psychoactive substances and products, with medicinal use or not, was completed by a specific system focused on evaluation and information on pharmacodependance in 1999. The French medicines agency (Agence du médicament) created in 1993 was involved in this monitoring system; pharmacodependance evaluation was added by law to the missions of the agencies that followed: the Agence française de sécurité sanitaire des produits de santé missions (AFSSAPS, 1998) and the Agence nationale de sécurité du médicament et des produits de santé (ANSM, 2011)...
August 3, 2018: Thérapie
Cécile Fokoun, Vanessa Labeye, Elodie Puzenat, Marina Atzenhoffer, Alain Sigal, Bruno Charpiat
No abstract text is available yet for this article.
August 2, 2018: Thérapie
Rim Masmoudi, Imen Baati, Kamilia Ksouda, Imen Abida, Rim Sellami, Hanene Affes, Dorsaf Trigui, Jawaher Masmoudi, Ines Feki
No abstract text is available yet for this article.
August 1, 2018: Thérapie
Neila Fathallah, Bouraoui Ouni, Sana Mokni, Khadija Baccouche, Amira Atig, Najat Ghariani, Awatef Azzabi, Mohamed Denguezli, Raoudha Slim, Chaker Ben Salem
INTRODUCTION: Drug-induced vasculitis is reported in almost 10-20 % of vasculitis. Several drugs may be incriminated in their occurrence. Our study aimed to study the epidemiological, clinical, histopathological and evolutionary characteristics of drug-indced vasculitis from a series of cases and to specify the different drugs involved. METHODS: We conducted a retrospective study during the period from January 2006 to December 2015 from the cases notified to the regional pharmacovigilance center of Sousse, Tunisia...
July 24, 2018: Thérapie
Marie-Blanche Valnet-Rabier, Charles Marcucci, Samuel Limat, Siamak Davani, François Aubin, Virginie Nerich
The immunotherapies known as "inhibitors of checkpoint" (ICP) are monoclonal antibodies used since 2010 and have dramatically modified the management of the advanced or metastatic melanomas. By reactivating the anti-tumoral immune response, these antibodies can activate the immune system in all the tissues with a risk to induce immune related adverse events (IrAE). Thus, the adverse effect's profile of ICP is considered as very different from that usually associated with conventional chemotherapies...
July 21, 2018: Thérapie
Béatrice Clarivet, Laure Vincent, Laurence Vergely, Virginie Bres, Kathleen Foglia, Guillaume Cartron, Dominique Hillaire-Buys, Jean-Luc Faillie
Post-marketing data regarding brentuximab vedotin (BV) are sparse. The aim of this study was to assess the frequency and nature of significant adverse drug reactions (ADRs) in patients treated with BV in a real-world setting. We conducted a systematic retrospective study of patients treated with BV in a French university hospital. Significant ADRs were collected using the electronic patient records. Between January 2009 and December 2016, 39 patients received BV. Median age was 43.2 and 53.8% were males. Overall, 20 patients (51...
July 20, 2018: Thérapie
Laurent Lam, Christelle Desitter, Patrick Maison
PURPOSE: To compare the regional demographic and health indicators to the pharmacovigilance activity of the regional pharmacovigilance centers in terms of number of cases collected, responses to information requests and signal detection in 2015. METHODS: The pharmacovigilance activity parameters (collected cases reports, information requests, reported serious cases) were expressed in regional proportions to population size and compared to regional demographic and health indicators (population, individuals aged 60 and over, individuals aged under 20, socio-professional categories, health facilities per capita, hospital beds [medicine, surgery and obstetrics] per capita, physicians and pharmacists per capita, mortality rate and drug consumption per capita) in 12 French metropolitan areas...
July 20, 2018: Thérapie
Shouquan Wu, Yu Wang, Miaomiao Zhang, Minggui Wang, Jian-Qing He
AIM: There is evidence to suggest that transforming growth factor-beta 1 takes part in a series of physiological and pathological processes in the human body, including wound healing, tissue fibrosis and embryonic development. We hypothesized that polymorphisms in the transforming growth factor-beta 1 gene single nucleotide polymorphisms (SNPs) were associated with anti-tuberculosis drug-induced liver injury (ATLI). METHODS: In a prospective study, 280 newly diagnosed tuberculosis patients were followed up for three months after initiating anti-tuberculosis therapy...
July 18, 2018: Thérapie
Ons Charfi, Imen Aouinti, Ahmed Zaiem, Ghozlane Lakhoua, Sihem El Aidli, Sarrah Kastalli
No abstract text is available yet for this article.
July 11, 2018: Thérapie
Jean Dallongeville, Frédéric Sacher, Stéphane Bouée, Corinne Emery, Isabelle Bureau, Julie Gourmelen, Laurent Fauchier
BACKGROUND: Little is known about the utilization of rivaroxaban in real life treatment settings in France. AIMS: Objectives of this study were to describe the conditions of use and treatment persistence in patients with atrial fibrillation and treated with rivaroxaban for stroke prevention (SP-AF). METHODS: A cohort study was performed using a representative sample of the French nationwide database. All adults who initiated rivaroxaban for SP-AF between 01/08/2012 and 31/12/2014 were included and followed for one year...
July 10, 2018: Thérapie
Elisabeth Frauger, Farid Kheloufi, Quentin Boucherie, Emilie Monzon, Leonard Jupin, Nathalie Richard, Michel Mallaret, Joëlle Micallef
Over the course of these last decades, we observed a change on opioid use with the marketing of opiate maintenance treatment, an increase of opioids used for pain management and recent concerns have arisen around the use of synthetic opioid. The World Health Organization (WHO) reports around 70,000 people opioid overdose death each year. In France, according to the DRAMES program (fatalities in relation with abuse of licit or illicit drugs) of the French addictovigilance network, most of deaths are related to opioids overdose (especially methadone, following by heroin, buprenorphine and opioid used for pain management)...
July 7, 2018: Thérapie
Anaïs Serre, Céline Eiden, Vincent Gourhant, Marion Laureau, Damien Perier, Isabelle Giraud, Mustapha Sebbane, Hélène Peyrière
INTRODUCTION: Due to the increase of hospitalization at emergency department (ED) related to psychoactive substances use (PSU), the addictovigilance center of Montpellier has been integrated into the URGEIM program for the detection of iatrogenic events at the ED. The objective of the present work was to analyze spontaneous reports (SR) collected via the URGEIM program. METHODS: Analysis of spontaneous reports related to PSU at the ED of the Montpellier University Hospital, collected through the URGEIM program, between January 2014 and December 2016...
June 28, 2018: Thérapie
Virginie Tournay, Antoine Pariente
This article aims at analyzing mechanisms leading to a situation of mistrust about the scientific evaluation of the medicinal product, beyond issues related to links of interests. The assumption is that conflicts of interest are only one component of this mistrust. It doesn't explain all social controversies affecting this sector, in particular the credibility of drug evaluation systems. We explore here how, during the six stages of certification that characterize the trajectory of the drug and its evaluation - the functioning of scientific production and collective representations contribute to this mistrust...
September 2018: Thérapie
Louise Carton, Nicolas Cabé, Olivier Ménard, Sylvie Deheul, Anne-Sylvie Caous, David Devos, Olivier Cottencin, Régis Bordet
For students, the pressing demands for memorization, top-level performance, and peer competition create an environment favorable for pharmaceutical cognitive doping behavior. We aimed to describe recent practices and the benefit/risk ratio of such behavior and to discuss the issues at stake. The prevalence of pharmaceutical cognitive doping among students has been reported from 1.3% to 33% across studies, with variations depending on country and definition of pharmaceutical cognitive doping. The therapeutic classes most frequently cited as being diverted for doping purposes are psychostimulants and nootropics (methylphenidate, modafinil, piracetam), corticosteroids, sedative drugs and beta-blockers...
September 2018: Thérapie
Ioanna Koniari, Nicholas G Kounis, Sophia N Kouni, Grigorios Tsigkas, George Soufras, George Hahalis
No abstract text is available yet for this article.
September 2018: Thérapie
Issam Salouage
No abstract text is available yet for this article.
September 2018: Thérapie
Florence Nicot, Niki Procopi, Lee S Nguyen
No abstract text is available yet for this article.
September 2018: Thérapie
Olfa Saidane, Meriem Sellami, Ines Mahmoud, Aicha Ben Tekaya, Rawdha Tekaya, Leila Abdelmoula
No abstract text is available yet for this article.
September 2018: Thérapie
Najla Bahloul, Lobna Ben Mahmoud, Hanen Ghozzi, Feten Hadjkacem, Khaled Zeghal, Mohamed Abid, Samy Kammoun
No abstract text is available yet for this article.
September 2018: Thérapie
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