15 results on '"Samy Babai"'
Search Results
2. Safety data and withdrawal of hepatotoxic drugs
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Samy Babai, Hervé Le-Louët, and Laurent Auclert
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0301 basic medicine ,Drug ,medicine.medical_specialty ,Ximelagatran ,Drug-Related Side Effects and Adverse Reactions ,media_common.quotation_subject ,Marketing authorization ,03 medical and health sciences ,Pharmacovigilance ,medicine ,Animals ,Humans ,Pharmacology (medical) ,Intensive care medicine ,media_common ,medicine.diagnostic_test ,United States Food and Drug Administration ,business.industry ,United States ,Discontinuation ,Clinical trial ,030104 developmental biology ,Pharmaceutical Preparations ,Chemical and Drug Induced Liver Injury ,Nefazodone ,Liver function tests ,business ,medicine.drug - Abstract
Summary Background and aim The occurrence of drug induced liver injury (DILI) is the most common reason of post-marketing withdrawals. DILI in humans is difficult to predict using in vitro cytotoxicity screening and animal studies. A review of hepatotoxicity data was performed with the aim of identifying relevant factors that could have predicted the occurrence of serious DILI. Methods The drugs withdrawn from the market due to hepatotoxicity in Europe and/or in USA either by marketing authorization holders or by Regulatory agencies from 1997 to 2016 were selected. The liver safety data and the withdrawal decisions were identified from a search within the European medicine agency (EMA) website, the Food and drug administration (FDA) orange book and PubMed®. Results From 1997 to 2016, eight drugs were withdrawn from the market for hepatotoxicity reason: tolcapone, troglitazone, trovafloxacin, bromfenac, nefazodone, ximelagatran, lumiracoxib and sitaxentan. The safety data suggest that while liver test abnormalities have been detected during clinical trials, other relevant factors leading to the discontinuation of these drugs have been identified: lack of predictability of animal models, inappropriate liver function test, non-compliance with drug treatment, less attention paid to rare adverse drug reactions, unpredictable occurrence and irreversible outcome of liver toxicity. Conclusion Several relevant factors may contribute to an inadequate risk management leading to the discontinuation of the drugs. Preclinical safety data are not sufficient to allow early prediction of DILI in humans and post-marketing safety monitoring and signal detection still should be used to identify potential serious cases of DILI. However, it seems that changes in Pharmacovigilance legislation with a closer management of drug safety may have contributed to the improvement of the risk minimization.
- Published
- 2021
3. Immune-related generalised oedema - A new category of adverse events with immune checkpoint inhibitors
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Maud Velev, Barouyr Baroudjian, Roxane Pruvost, Eleonora De Martin, Ariane Laparra, Samy Babai, Sandra Teysseire, François-Xavier Danlos, Laurence Albiges, Charlotte Bernigaud, Marc-Antoine Benderra, Pauline Pradère, Mohamad Zaidan, Chantal Decroisette, Fatma Fallah, Gaelle Matergia, Pernelle Lavaud, Hélène Jantzem, Marina Atzenhoffer, Véronique Buyse, Samy Ammari, Caroline Robert, Stéphane Champiat, Sabine Messayke, Aurélien Marabelle, Catherine Guettier, Céleste Lebbe, Olivier Lambotte, and Jean-Marie Michot
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Cancer Research ,Oncology - Abstract
Generalised oedema was occasionally reported associated with immune checkpoint inhibitors (ICPIs). The purpose of this study is to investigate immune-related generalised oedema (ir-GE) drug related to ICPI, through frequency, clinical and pathological characteristics, and patient's outcome.Objectives of the study were to report on ir-GE associated with ICPI to define frequency, associated signs and symptoms, pathological characteristics, severity, and response to corticosteroids. To be included in the study, adult patients had to have ir-GE related to ICPI with certain or likely link, without any other known causes of generalised oedema. The study design was observational, over the period 2014-2020, from pharmacovigilance databases in France, including the prospective Registre des Effets Indésirables Sévères des Anticorps Monoclonaux Immunomodulateurs en Cancérologie (REISAMIC) registry. Calculation of the frequency of ir-GE was restricted to the prospective REISAMIC registry.Over 6633 screened patients, 20 had ir-GE confirmed drug related to ICPI. Based on the prospective REISAMIC registry, the frequency of ir-GE was 0.19% of ICPI-treated patients (3 cases out of 1598 screened patients). The 20 patients with ir-GE had a median (range) age of 62 (26-81) years, most frequent tumour types were melanoma (n = 9; 45%) and lung cancer (n = 6; 30%). The most frequent localisations of oedema were peripheral (n = 17; 85%), pleural (n = 13; 65%), and peritoneal (n = 10; 50%). Polyserositis was observed in 11 (55%) patients. The median (range) weight gain per patient was 9 (2-30) kg. Associated signs and symptoms met criteria for capillary leak syndrome (n = 4; 20%), sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) (n = 3; 15%), or subcutaneous autoimmune syndrome (n = 2; 10%). Corticosteroids were administered to 15 patients; of them, 10 (67%) improved clinically after corticosteroids. Based on CTCAEV5.0, the highest severity of ir-GE was grade ≥4 in 11 (55%) patients and four (20%) patients died due to ir-GE.Generalised immune system-related oedema is a new category of adverse event with immune checkpoint inhibitors and is often associated with a life-threatening condition. The pathophysiology may in some cases be related to endothelial dysfunctions, such as SOS/VOD or capillary leak syndrome.
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- 2022
4. Thyroiditis and immune check point inhibitors: the post-marketing experience using the French National Pharmacovigilance database
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Nadine Petitpain, Julie Garon-Czmil, Franck Rouby, Marion Sassier, Georges Weryha, Marc Klein, Pierre Gillet, Samy Babai, Melissa Yelehe-Okouma, Centre Régional de PharmacoVigilance de Lorraine (CRPV Lorraine), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service d'Endocrinologie et Gynécologie Médicale [CHRU Nancy], Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Institut de Neurosciences des Systèmes (INS), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de Pharmacologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre régional de pharmacovigilance [CHU Henri-Mondor], CHU Henri Mondor [Créteil], Ingénierie Moléculaire et Physiopathologie Articulaire (IMoPA), Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), CHU Marseille-Assistance Publique-Hôpitaux de Marseille (AP-HM), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Université de Caen Normandie (UNICAEN), Normandie Université (NU), and CHU Henri Mondor
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Adult ,Male ,Thyroiditis ,Time Factors ,Databases, Factual ,Levothyroxine ,Ipilimumab ,Pembrolizumab ,Antibodies, Monoclonal, Humanized ,computer.software_genre ,Risk Assessment ,030226 pharmacology & pharmacy ,Pharmacovigilance ,Young Adult ,03 medical and health sciences ,Antineoplastic Agents, Immunological ,0302 clinical medicine ,Risk Factors ,Product Surveillance, Postmarketing ,Adverse Drug Reaction Reporting Systems ,Humans ,Medicine ,Pharmacology (medical) ,ComputingMilieux_MISCELLANEOUS ,Aged ,Retrospective Studies ,Aged, 80 and over ,Pharmacology ,Database ,business.industry ,Thyroid ,Middle Aged ,medicine.disease ,3. Good health ,Discontinuation ,Nivolumab ,medicine.anatomical_structure ,Female ,France ,business ,computer ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology ,030217 neurology & neurosurgery ,medicine.drug - Abstract
Immunotherapy with immune checkpoint inhibitors (ICIs) for cancer has become increasingly prescribed in recent years. Indeed, it is used to treat both solid and hematological malignancies due to their considerable potential in treating melanoma, non-small cell lung and other cancers. Immune-mediated related adverse endocrine toxicity, and especially thyroiditis, is seen as a growing problem needing specific screening and management. This study aims at describing thyroid dysfunctions induced by the ICIs marketed in France, which are registered in the French Pharmacovigilance database. This database was queried for nivolumab, pembrolizumab, and ipilimumab-induced adverse drug reactions reported before April 30, 2017. Both a pharmacologist and an endocrinologist have reviewed each case to select only those of peripheral thyroiditis (thyrotoxicosis and hypothyroidism). During this period, 110 thyroiditis following ICI therapy were reported. Sex/ratio was around one. Most of the cases (47.2%) were asymptomatic. Although some thyrotoxicosis cases were severe, no orbitopathy was reported. Hypothyroidism and thyrotoxicosis were equally described. Antithyroid antibodies were positive in only 16% patients. The ultrasonography was informative in 19% patients. Levothyroxine supplementation was necessary in 57% patients, leading to 19% recovery. With a dedicated optimized management, most of the cases did not require immunotherapy discontinuation. Finally, immune-mediated related thyroiditis is increasing due to a wider prescription of ICI therapy in various cancer conditions and systematic screening. Often asymptomatic, they lead to a local activation accompanied by hormonal deficiency in the long run. It is necessary to carry out an early and sustained multidisciplinary screening to allow immunotherapy continuation.
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- 2018
5. Incretin-based drugs and intestinal obstruction: A pharmacovigilance study
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Marie-Laure Laroche, Jean-Luc Faillie, Dominique Hillaire-Buys, Perrine Robin, Bastien Gudin, Chayma Ladhari, Samy Babai, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Ciblage individuel et prévention des risques de traitements immunosupresseurs et de la transplantation (IPPRITT), CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 (AIDMP), Université Montpellier 1 (UM1)-Université de Montpellier (UM), and CCSD, Accord Elsevier
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Drug ,medicine.medical_specialty ,Databases, Factual ,media_common.quotation_subject ,MedDRA ,[SDV]Life Sciences [q-bio] ,Adverse drug reaction ,Incretin ,030226 pharmacology & pharmacy ,Incretins ,03 medical and health sciences ,Pharmacovigilance ,0302 clinical medicine ,Ileus ,Diabetes mellitus ,Internal medicine ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,Adverse effect ,Incretin-based drugs ,media_common ,Dipeptidyl-Peptidase IV Inhibitors ,business.industry ,Odds ratio ,medicine.disease ,3. Good health ,[SDV] Life Sciences [q-bio] ,Pharmaceutical Preparations ,Intestinal obstruction ,business - Abstract
Summary Aims To investigate the risk of intestinal obstruction associated with incretin-based drugs by performing a disproportionality analysis of adverse reaction reports in a global pharmacovigilance database. Methods We conducted a case/non-case analysis using VigiBase, the World Health Organization's adverse drug reactions (ADR) database, to assess intestinal obstruction reporting associated with incretin-based drugs (glucagon-like peptide 1 analogues [GLP-1a] and dipeptidyl peptidase 4 inhibitors [DPP-4i]. Cases were defined as reports of gastrointestinal stenosis and obstruction (MedDRA High Level Group Term) and non-cases were all other reactions recorded. Disproportionality analysis were performed by computing reporting odds ratios (ROR) with their 95% confidence interval (95%CI) within all ADR reports concerning diabetes drugs from January 2007 to January 2018 and in a restricted sample including only serious reports. Results A total of 501,244 ADR with diabetes drugs were reported in VigiBase during the study period. We identified 452 intestinal obstructions involving an incretin-based drug. In disproportionality analyses, intestinal obstructions were more than 4.5 times more frequently reported with incretin-based drugs than with other diabetes drugs (ROR 4.52, 95% CI: 3.87–5.28) with a higher signal for serious cases and for DPP-4i (ROR 8.66, 95% CI: 7.27–10.32) compared to GLP-1a (ROR 3.05, 95% CI: 2.54–3.66). Conclusions We identified a pharmacovigilance signal that suggests a risk of potentially serious intestinal obstruction associated with incretin-based drugs, as a class and with a greater signal for DPP4-i. Other studies are needed to confirm and better understand the potential risk of intestinal obstruction associated with incretin-based drugs.
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- 2020
6. Occurrences and Outcomes of Immune Checkpoint Inhibitors-Induced Vitiligo in Cancer Patients: A Retrospective Cohort Study
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Anne-Laure Voisin, Amandine Gouverneur, Hervé Le-Louët, Célia Bertin, and Samy Babai
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Adult ,Male ,medicine.medical_specialty ,Lung Neoplasms ,Vitiligo ,Ipilimumab ,Pembrolizumab ,Toxicology ,Antibodies, Monoclonal, Humanized ,030226 pharmacology & pharmacy ,Cohort Studies ,03 medical and health sciences ,Pharmacovigilance ,0302 clinical medicine ,Antineoplastic Agents, Immunological ,Interquartile range ,Carcinoma, Non-Small-Cell Lung ,medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,skin and connective tissue diseases ,Melanoma ,Aged ,Retrospective Studies ,Pharmacology ,Aged, 80 and over ,integumentary system ,business.industry ,Cancer ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Dermatology ,Nivolumab ,Treatment Outcome ,Female ,France ,business ,medicine.drug - Abstract
The use of immune checkpoint inhibitors (ICI) in melanoma and non-small cell lung cancer patients is associated with the onset of vitiligo. However, previous studies have suggested conflicting results on the conditions of occurrence of ICI-induced vitiligo. The aim of this study was to describe the occurrences and outcomes of several cases of ICI-induced vitiligo. A retrospective study was carried out using the French Pharmacovigilance Database (FPD) between the beginning of the commercialization of ICI in France and 1 January 2019, selecting for analysis the vitiligo reactions of patients due to treatment with ICI. Among the 95 case patients identified in the FPD, the median times to onset of vitiligo after the start of pembrolizumab, nivolumab and ipilimumab therapies were 5.4, 5.0, and 3.8 months, respectively. Furthermore, 37 patients (45%) discontinued ICI treatment due to disease progression. The median follow-up time of all patients was 33 months (interquartile range 2–56). This study provided an overall picture of ICI-induced vitiligo in daily medical practice on a large number of pharmacovigilance observations of case patients. Among the observations of ICI-induced vitiligo, the diagnosed cancer was melanoma for almost all patients. Most patients in the study experienced other associated adverse drug reactions (ADRs), such as colitis, pruritus, hypothyroidism, hyperthyroidism, thyroiditis, pancreatitis, and gastritis. Furthermore, our data suggest that the resolution of pembrolizumab- or nivolumab-induced vitiligo could be a marker of disease progression. Future studies evaluating vitiligo outcomes are warranted.
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- 2019
7. Comparison of Adverse Drug Reactions with Donepezil versus Memantine: Analysis of the French Pharmacovigilance Database
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Pascal Auriche, Hervé Le-Louët, and Samy Babai
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Male ,Drug ,Bradycardia ,Weakness ,Databases, Factual ,media_common.quotation_subject ,computer.software_genre ,Pharmacotherapy ,Piperidines ,Alzheimer Disease ,Memantine ,mental disorders ,Pharmacovigilance ,Product Surveillance, Postmarketing ,medicine ,Humans ,Donepezil ,Pharmacology (medical) ,Nootropic Agents ,Aged ,media_common ,Aged, 80 and over ,Database ,business.industry ,Middle Aged ,medicine.disease ,Indans ,Female ,France ,Alzheimer's disease ,medicine.symptom ,business ,computer ,medicine.drug - Abstract
Background Since donepezil and memantine are currently used for treating Alzheimer’s disease, it is interesting to analyse, reassess and compare their safety profile in order to promote a better use. Methods All spontaneous reports of suspected serious adverse drug reactions with donepezil alone and with memantine alone recorded in the French Pharmacovigilance Database during 6 years were retrospectively analysed. Results The most frequent adverse drug reactions with donepezil alone and memantine alone were respectively: bradycardia (10% versus 7%), weakness (5% versus 6%) and convulsions (4% versus 3%). Conclusion The most adverse drug events with donepezil and with memantine are associated with elderly people, even if they do not receive any other treatment. Donepezil and memantine have an acceptable safety profile but physicians should take special care when they prescribe any drug known to cause bradycardia or to reduce the epileptogenic threshold.
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- 2010
8. Signalement d’événements indésirables par les patients : étude pilote réalisée avec la collaboration d’associations de patients
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Samy Babai, Daphney Nasrallah-Irles, Laure Thomas, Anne Castot, Hervé Le-Louët, and Bernard Delorme
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Gynecology ,medicine.medical_specialty ,business.industry ,Medicine ,Pharmacology (medical) ,business - Abstract
Resume Introduction L’evolution des systemes de vigilance des produits de sante tend a une implication croissante des patients. C’est pourquoi, le signalement, par le patient lui-meme, de son effet indesirable medicamenteux doit etre envisage. Materiel et methodes Afin de determiner la faisabilite d’une telle procedure et les outils necessaires, une etude pilote a ete realisee par l’Afssaps (Agence francaise de securite sanitaire des produits de sante) a la demande de 23 associations de patients. Un questionnaire specifique « patient » a ete elabore et mis a la disposition des membres de ces associations. Resultats Entre le 1er septembre 2006 et le 31 aout 2007, 200 signalements-patients ont ete colliges et analyses. Il s’agit majoritairement d’evenements « graves », en termes de consequence sur la qualite de vie mais connus. La qualite des informations recueillies montre que les outils proposes etaient adaptes. Conclusion Le patient, aide par son association, peut fournir des donnees de tolerance « contributives », concernant notamment le retentissement sur la vie quotidienne.
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- 2008
9. Adverse Drug Reactions with Donepezil: Analysis of the French Pharmacovigilance Database
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W. E. Bourzam, Hélène Brocvielle, Samy Babai, and H Le Louet
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Pharmacology ,medicine.medical_specialty ,business.industry ,Pharmacology toxicology ,Toxicology ,Pharmacovigilance ,medicine ,Pharmacology (medical) ,Drug reaction ,Donepezil ,Intensive care medicine ,business ,medicine.drug - Published
- 2008
10. Bullous pemphigoid induced by vildagliptin: a report of three cases
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Aurélie Jacobsoone, Annie Vermersch, Johana Béné, Anne-Fleur Tronquoy, Marlène Vonarx, Marine Auffret, Dominique Hillaire-Buys, Patrick Coupe, Samy Babai, Sophie Gautier, Marie-Josèphe Jean-Pastor, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Claude Huriez [Lille], CHU Lille, CH Valenciennes, Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Pathogénèse et contrôle des infections chroniques (PCCI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre Hospitalier Universitaire de Montpellier (CHU Montpellier ), Hôpital Salvator [CHU - APHM] (Hôpitaux Sud), and Herrada, Anthony
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Male ,bullous pemphigoid ,medicine.medical_specialty ,Pyrrolidines ,030209 endocrinology & metabolism ,Adamantane ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Nitriles ,Pemphigoid, Bullous ,medicine ,Humans ,Pharmacology (medical) ,Vildagliptin ,Gliclazide ,adverse reactions ,skin and connective tissue diseases ,Aged ,Pharmacology ,Aged, 80 and over ,Dipeptidyl-Peptidase IV Inhibitors ,integumentary system ,business.industry ,Type 2 Diabetes Mellitus ,medicine.disease ,Dermatology ,eye diseases ,3. Good health ,Discontinuation ,Metformin ,[SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology ,Clobetasol ,Sitagliptin ,drug-induced skin disorder ,gliptins ,[SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology ,Female ,Bullous pemphigoid ,business ,medicine.drug - Abstract
International audience; To report three cases of bullous pemphigoid in patients treated with vildagliptin. Case 1: An 86-year-old woman presented with bullous pemphigoid after 1 month of treatment with vildagliptin and metformin. After introduction of clobetasol, the symptoms resolved although vildagliptin was continued. However, the skin lesions reappeared 3 months later. Sustained remission was achieved only after definitive withdrawal of vildagliptin. Case 2: A 79-year-old man presented with bullous pemphigoid after 37-month treatment with gliclazide, vildagliptin and metformin. The disease at first responded to clobetasol but 3 months later the lesions reappeared. They finally regressed when the gliptin was discontinued. Case 3: A 77-year-old woman, treated with gliclazide and vildagliptin for 26 months, presented with bullous pemphigoid, which responded well to discontinuation of the gliptin and topical clobetasol. Gliptins are new molecules for treatment of type 2 diabetes mellitus, which have been suspected of implication in bullous pemphigoid. Such cases have been described in the literature (seven with vildagliptin and three with sitagliptin). In nine of these cases, the gliptin was associated with metformin, but the latter had never been considered responsible. The mechanism implicated in the development of bullous pemphigoid has not yet been clearly identified, but may involve a modified immune response or alteration of the antigenic properties of the epidermal basement membrane. These reports support the risk of bullous pemphigoid in patients exposed to gliptins.
- Published
- 2015
11. Pancreatitis associated with the use of GLP-1 analogs and DPP-4 inhibitors: a case/non-case study from the French Pharmacovigilance Database
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Sabrina Crépin, Pierre Petit, Jean-Louis Montastruc, Samy Babai, Virginie Bres, Hervé Le Louet, Dominique Hillaire-Buys, Jean-Luc Faillie, Marie-Laure Laroche, Daviet, Jean-Christophe, Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de Pharmacologie, toxicologie et pharmacovigilance [CHU Limoges], CHU Limoges, Handicap, Activité, Vieillissement, Autonomie, Environnement (HAVAE), Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Pathogénèse et contrôle des infections chroniques (PCCI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre Hospitalier Universitaire de Montpellier (CHU Montpellier ), Laboratoire Microorganismes : Génome et Environnement (LMGE), Université Blaise Pascal - Clermont-Ferrand 2 (UBP)-Université d'Auvergne - Clermont-Ferrand I (UdA)-Centre National de la Recherche Scientifique (CNRS), Institut Charles Sadron (ICS), Université de Strasbourg (UNISTRA)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Réseau nanophotonique et optique, Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Matériaux et nanosciences d'Alsace (FMNGE), Institut de Chimie du CNRS (INC)-Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), and Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées
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Male ,Databases, Factual ,Endocrinology, Diabetes and Metabolism ,pancreatitis ,dipeptidyl peptidase 4 inhibitors ,Saxagliptin ,computer.software_genre ,chemistry.chemical_compound ,0302 clinical medicine ,Endocrinology ,Glucagon-Like Peptide 1 ,Vildagliptin ,030212 general & internal medicine ,Aged, 80 and over ,[SDV.MHEP.EM] Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism ,glucagon-like peptide 1 analogs ,Database ,General Medicine ,Middle Aged ,[SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism ,3. Good health ,Sitagliptin ,[SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology ,Female ,France ,medicine.drug ,Adult ,Incretin ,030209 endocrinology & metabolism ,03 medical and health sciences ,Pharmacovigilance ,Type 2 diabetes mellitus ,Internal Medicine ,medicine ,Humans ,Aged ,Dipeptidyl-Peptidase IV Inhibitors ,business.industry ,Liraglutide ,[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,medicine.disease ,[SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,chemistry ,Diabetes Mellitus, Type 2 ,Case-Control Studies ,pharmacovigilance ,[SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology ,Pancreatitis ,business ,computer ,Exenatide ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
International audience; : In the recent past, concerns have raised regarding the potential risk of acute pancreatitis among type 2 diabetic patients using incretin-based drugs such as glucagon-like peptide 1 (GLP-1) analogs and dipeptidyl peptidase 4 (DPP-4) inhibitors. The aim of this study is to investigate the association between exposure to incretin-based drugs and the occurrence of pancreatitis reported in the French Pharmacovigilance Database. The case/non-case method was performed from serious adverse drug reactions (ADRs) involving antihyperglycemic agents (except insulin alone) reported to the French pharmacovigilance system between March 2008 (first marketing of an incretin-based drug in France) and March 2013. Cases were defined as reports of pancreatitis, and all other serious ADRs were considered non-cases. Disproportionality was assessed by calculating reporting odds ratios (ROR) adjusted for age, gender, history of pancreatitis, other antihyperglycemic drugs and other drugs associated with a higher risk of pancreatitis. Among 3,109 serious ADRs, 147 (4.7 %) reports of pancreatitis were identified as cases and 2,962 reports (95.3 %) of other ADRs as non-cases. Among the cases, 122 (83.0 %) involved incretin-based drugs. Disproportionality was found for all incretin-based drugs (adjusted ROR: 15.7 [95 % CI 9.8-24.9]), all GLP-1 analogs (29.4 [16.0-53.8]), exenatide (28.3 [12.8-62.3]), liraglutide (30.4 [15.4-60.0]), all DPP-4 inhibitors (12.1 [7.3-20.0]), sitagliptin (12.4 [7.3-21.0]), saxagliptin (15.1 [4.3-52.7]), and vildagliptin (7.4 [3.1-17.6]). Temporal analysis found disproportionality for incretin-based drugs since their first year of marketing in France. Compared with other antihyperglycemic agents, use of incretin-based drugs is associated with an increased risk of reported pancreatitis in France.
- Published
- 2013
12. Severe hyponatremia caused by nab-paclitaxel-induced syndrome of inappropriate antidiuretic hormone secretion
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Géraldine Pujol, Samy Babai, Emmanuelle Kempf, Benoit Rousseau, Hervé Le-Louët, Christophe Tournigand, and Cindy Neuzillet
- Subjects
Male ,Oncology ,medicine.medical_specialty ,Paclitaxel ,hyponatremia ,vasopressin ,pancreatic cancer ,Adenocarcinoma ,Neutropenia ,chemotherapy ,Severity of Illness Index ,Inappropriate ADH Syndrome ,03 medical and health sciences ,0302 clinical medicine ,Albumins ,Internal medicine ,medicine ,Humans ,imputability ,Clinical Case Report ,030212 general & internal medicine ,Intensive care medicine ,Adverse effect ,Aged ,Performance status ,business.industry ,General Medicine ,Metastatic Pancreatic Adenocarcinoma ,medicine.disease ,taxanes ,Gemcitabine ,Pancreatic Neoplasms ,Regimen ,030220 oncology & carcinogenesis ,Syndrome of inappropriate antidiuretic hormone secretion ,Hyponatremia ,business ,Research Article ,medicine.drug - Abstract
Incidence of pancreatic ductal adenocarcinoma (PDAC) is increasing. Most patients have advanced disease at diagnosis and therapeutic options in this setting are limited. Gemcitabine plus nab-paclitaxel regimen was demonstrated to increase survival compared with gemcitabine monotherapy and is therefore indicated as first-line therapy in patients with metastatic PDAC and performance status Eastern Cooperative Oncology Group (ECOG) 0-2. The safety profile of gemcitabine and nab-paclitaxel combination includes neutropenia, fatigue, and neuropathy as most common adverse events of grade 3 or higher. No case of severe hyponatremia associated with the use of nab-paclitaxel for the treatment of PDAC has been reported to date. We report the case of a 72-year-old Caucasian man with a metastatic PDAC treated with gemcitabine and nab-paclitaxel regimen, who presented with a severe hyponatremia (grade 4) caused by a documented syndrome of inappropriate antidiuretic hormone secretion (SIADH). This SIADH was attributed to nab-paclitaxel after a rigorous imputability analysis, including a rechallenge procedure with dose reduction. After dose and schedule adjustment, nab-paclitaxel was pursued without recurrence of severe hyponatremia and with maintained efficacy. Hyponatremia is a rare but potentially severe complication of nab-paclitaxel therapy that medical oncologists and gastroenterologists should be aware of. Nab-paclitaxel-induced hyponatremia is manageable upon dose and schedule adaptation, and should not contraindicate careful nab-paclitaxel reintroduction. This is of particular interest for a disease in which the therapeutic options are limited.
- Published
- 2016
13. P2‐263: Comparison of adverse drug reactions with donepezil versus memantine: Analysis of the French pharmacovigilance database
- Author
-
Pascal Auriche, Hervé Le Louet, and Samy Babai
- Subjects
Epidemiology ,business.industry ,Health Policy ,Memantine ,Psychiatry and Mental health ,Cellular and Molecular Neuroscience ,Developmental Neuroscience ,Anesthesia ,Pharmacovigilance ,medicine ,Neurology (clinical) ,Drug reaction ,Geriatrics and Gerontology ,Donepezil ,business ,medicine.drug - Published
- 2009
14. [Adverse drug reactions: a pilot study on patient reporting through patient associations]
- Author
-
Daphney, Nasrallah-Irles, Anne, Castot, Laure, Thomas, Samy, Babai, Bernard, Delorme, and Hervé, Le-Louët
- Subjects
Drug Therapy ,Drug-Related Side Effects and Adverse Reactions ,Patients ,Quality of Life ,Humans ,Safety ,Monitoring, Physiologic - Abstract
The expected evolution of monitoring systems for health products, aims at increasing the involvement of patients into health products safety system. As a result, it seems necessary to consider the ability for patients to directly report their own adverse events.A pilot study has been undertaken by Afssaps (Health Agency) for 23 patient associations using a reporting form specially created for patients.According to the analysis of the first 200 reports, received from June 2006 to August 2007, the reported adverse events are mostly serious in terms of consequences on patients' quality of life and expected. The quality of information shows that the proposed tools are adequate and could be used in case of a future change in legislation allowing patient reporting of adverse events.The patient, eventually helped by his association, may provide contributory safety information, especially regarding side effects affecting daily life.
- Published
- 2009
15. DRESS: is oxcarbazepine safer than carbamazepine? An analysis of the French Pharmacovigilance database
- Author
-
Laure Thomas, H. Le Louët, and Samy Babai
- Subjects
Epilepsy ,Databases, Factual ,business.industry ,Oxcarbazepine ,Carbamazepine ,Epilepsy seizure ,medicine.disease ,Neurology ,SAFER ,Pharmacovigilance ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Anticonvulsants ,Neurology (clinical) ,Medical emergency ,France ,business ,medicine.drug - Published
- 2008
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