61 results on '"Geneviève Durrieu"'
Search Results
2. Drug-induced hypohidrosis and anhidrosis: analysis of the WHO pharmacovigilance database 2000–2020
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Jean-Louis Montastruc and Geneviève Durrieu
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Hypohidrosis ,Pharmacology ,Pharmacovigilance ,Databases, Factual ,Humans ,Pharmacology (medical) ,General Medicine ,World Health Organization - Published
- 2022
3. Fatal adverse drug reactions: A worldwide perspective in the World Health Organization pharmacovigilance database
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Jean-Louis Montastruc, Geneviève Durrieu, François Montastruc, Agnès Sommet, Haleh Bagheri, Claire de Canecaude, and Margaux Lafaurie
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Adult ,Male ,Drug ,Adolescent ,Databases, Factual ,Drug-Related Side Effects and Adverse Reactions ,media_common.quotation_subject ,World Health Organization ,computer.software_genre ,030226 pharmacology & pharmacy ,World health ,Immunomodulating Agents ,Pharmacovigilance ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Drug reaction ,Retrospective Studies ,Lenalidomide ,media_common ,Pharmacology ,Database ,business.industry ,Odds ratio ,Confidence interval ,Thalidomide ,Pharmaceutical Preparations ,Female ,business ,computer ,medicine.drug - Abstract
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. Methods A retrospective analysis of VigiBase, the World Health Organization pharmacovigilance database, was performed investigating fatal ADRs registered between 1 January 2010 and 31 December 2019 in male and female patients aged ≥18 years and reported by physicians. Analyses were descriptive investigating age, sex and suspected drugs. Differences in reporting according to sex, age and continents were investigated using disproportionality analysis with calculation of reporting odds ratio and its 95% confidence interval. Results Among the 23 millions ADRs recorded in VigiBase, 3 250 967 were included with 43 685 fatal. They were reported mainly in patients older than 75 years. The 3 most frequently involved drug classes were antineoplastic/immunomodulating drugs followed by nervous system and cardiac drugs. The top 3 individual drugs were denosumab, lenalidomide and thalidomide with marked differences according to age, sex, continents and countries. The risk of reporting fatal ADRs was higher in males, in the Americas and in patients ≥65 years. Conclusion Fatal ADRs registered in a large pharmacovigilance database during the last 10 years correspond to just over 1% of the total number of ADRs. They occurred more in males, after 65 years and with antineoplastic/immunomodulating drugs in general. Our study also highlighted, for the first time, important differences in fatal ADRs between continents and countries.
- Published
- 2021
4. Drug-Induced Hearing Loss in Children: An Analysis of Spontaneous Reports in the French PharmacoVigilance Database
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Florentia Kaguelidou, Vanessa Rousseau, Leila Chebane, Jean-Louis Montastruc, Marie Boyer Gervoise, Geneviève Durrieu, Alexandra Weckel, Joëlle Michot, Véronique Pizzoglio-Bellaudaz, and Adrien Gainville
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Male ,Adolescent ,Databases, Factual ,Hearing loss ,computer.software_genre ,Pharmacovigilance ,03 medical and health sciences ,0302 clinical medicine ,Pharmacotherapy ,Clarithromycin ,otorhinolaryngologic diseases ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,Child ,Hearing Loss ,Isotretinoin ,Retrospective Studies ,030203 arthritis & rheumatology ,Database ,business.industry ,Infant, Newborn ,Infant ,Retrospective cohort study ,medicine.disease ,Amikacin ,Child, Preschool ,Pediatrics, Perinatology and Child Health ,Female ,medicine.symptom ,business ,computer ,030217 neurology & neurosurgery ,Adverse drug reaction ,medicine.drug - Abstract
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. The objective of our study was to describe drug-induced hearing loss in the pediatric population. Reports of hearing loss from 1985 to December 2019 in the pediatric population (< 18 years) were extracted from the French PharmacoVigilance Database (FPVD). We performed a retrospective and descriptive analysis of adverse drug reaction (ADR) reports. A total of 70 ADR reports were identified among the 51,216 reports registered in the FPVD, 37 involving adolescents (12–17 years, 52.9%), 28 children (2–11 years, 40.0%), and 5 infants (28 days–23 months, 7.1%). Overall, 40 reports (57.1%) involved girls. A total of 56 reports (80.0%) were “serious.” The most frequent hearing disorders were deafness (n = 31, 44.3%) and hypoacusis (n = 22, 31.4%). Suspected drugs (ATC 5th level) were amikacin (n = 11, 15.7%), cisplatin (n = 11, 15.7%), doxorubicin (n = 4, 5.7%), vincristine (n = 4, 5.7%), clarithromycin (n = 4, 5.7%), ceftriaxone (n = 3, 4.3%), isotretinoin (n = 3, 4.3%), and vancomycin (n = 3, 4.3%). This study shows that about three out of four cases of drug-induced hearing loss in the pediatric population were “serious”. It also underlines the under-reporting of these ADRs and the importance of strengthening hearing monitoring in children during and long after drug exposure.
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- 2020
5. Can tramadol really induce hyponatraemia? A pharmacovigilance study
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Vanessa Rousseau, Jean-Louis Montastruc, Leila Chebane, Claire de Canecaude, Margaux Lafaurie, and Geneviève Durrieu
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medicine.medical_specialty ,Databases, Factual ,endocrine system diseases ,030226 pharmacology & pharmacy ,Pharmacovigilance ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Tramadol ,Pharmacology ,business.industry ,Confounding ,nutritional and metabolic diseases ,Preferred Term ,Odds ratio ,nervous system diseases ,Concomitant ,business ,Hyponatremia ,medicine.drug - Abstract
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. All 1992-2019 ICSRs (individual case safety reports) with the preferred term (PT) "hyponatraemia" and tramadol were included. Two disproportionality analyses were performed: (1) after inclusion of all reports, and (2) after exclusion of concomitant hyponatraemic drugs. Results are expressed as reporting odds ratios (ROR; 95% CI) and information component (IC). Of 19 747 604 ICSRs, 225 575 were included. A significant association was found between tramadol use and reports of hyponatraemia (ROR = 1.49 [1.39-1.60], IC = 0.57 [IC025 = 0.47]). After exclusion of hyponatraemic drugs, the previously found association disappeared. The study failed to find any pharmacovigilance signal of hyponatraemia with tramadol alone. We suggest that reports of hyponatraemia with tramadol can be explained principally by other underlying causes of hyponatraemia, especially other concomitant hyponatraemic drugs.
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- 2020
6. Informativité des déclarations de pharmacovigilance en médecine générale en France
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Geneviève Durrieu, Sophie Fedrizzi, Joachim Alexandre, Ninon Robin, Cécile Pageot, Antoine Coquerel, Xavier Humbert, Caroline Joyau, Farid Kheloufi, Marion Sassier, and Julien Jacquot
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Practice patterns ,business.industry ,Pharmacovigilance ,Public Health, Environmental and Occupational Health ,Medicine ,business ,Humanities - Abstract
Introduction : La notification spontanee des effets indesirables medicamenteux (EIMs) est un des piliers de la surveillance en post-AMM. Une des principales limites de cette derniere concerne la qualite de l’information de ces notifications.L’objectif principal de cette etude etait d’evaluer l’informativite des observations d’EIMs enregistrees dans la Base Nationale de PharmacoVigilance (BNPV) a partir des declarations des medecins generalistes (MGs). L’objectif secondaire etait d’identifier les facteurs associes a une declaration complete.Methode : Toutes les observations d’EIMs declarees en France, en 2015, par les MGs ont ete extraites. Apres analyse du contenu de ces declarations (EIM, date d’apparition, description clinique, medicament impute, etc.), l’informativite etait analysee a partir de plusieurs criteres obligatoires (âge, genre, EIM et medicament(s) suspecte(s)) et facultatifs (antecedents medicaux, medicaments concomitants, evolution de la symptomatologie et examens complementaires) ; cela a permis de classifier les declarations en « bien renseignee », « moyennement renseignee » et « mal renseignee ».Resultats : Durant l’annee 2015, la BNPV comportait 3 020 declarations realisees par les MGs francais. Seulement 16,4 % des declarations de pharmacovigilance rapportees etaient « bien renseignees ». Les criteres les moins bien documentes etaient les medicaments concomitants (41,4 %) et les examens complementaires (37,4 %). Les observations completes etaient associees a la gravite des cas (OR = 3,02 [IC 95 % 2,44 ; 3,23], p
- Published
- 2019
7. Adverse drug reactions of statins in children and adolescents: a descriptive analysis from VigiBase, the WHO global database of individual case safety reports
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Vanessa Rousseau, Geneviève Durrieu, François Montastruc, Jean-Louis Montastruc, Cécile Conte, Pascale Olivier, and Charlotte Vert
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myalgia ,Adolescent ,Databases, Factual ,Drug-Related Side Effects and Adverse Reactions ,MedDRA ,Poison control ,Global Health ,World Health Organization ,computer.software_genre ,030226 pharmacology & pharmacy ,Suicide prevention ,Rhabdomyolysis ,Occupational safety and health ,03 medical and health sciences ,Age Distribution ,0302 clinical medicine ,Quality of life ,Pharmacovigilance ,Injury prevention ,Adverse Drug Reaction Reporting Systems ,Humans ,Medicine ,Pharmacology (medical) ,Child ,Pharmacology ,Database ,business.industry ,Myalgia ,Child, Preschool ,Chemical and Drug Induced Liver Injury ,Hydroxymethylglutaryl-CoA Reductase Inhibitors ,medicine.symptom ,business ,computer ,030217 neurology & neurosurgery - Abstract
In adults, statins safety profile is well known. However, literature data on their adverse drug reactions (ADRs) remain scarce in children in real-life setting. In order to better characterize ADRs related to 'real-life' use of statins in children, we reviewed statin-related ADRs recorded in the World Health Organization (WHO) global database of individual case safety reports (ICSRs), VigiBase. Methods. Individual case safety reports (ICSRs) in children (2-11 years) and adolescents (12-17 years) associated with statins from January 1, 1987, to July 18, 2017, were extracted from VigiBase. Characteristics of ICSRs, type of ADRs according to MedDRA classification (SOC and PT), and ICSR seriousness were described using SAS 9.4. A total of 311 ICSRs were identified for 8 statins with 712 ADRs. Musculoskeletal disorders (n = 85, 27.3%) were the first registered ADRs followed by general disorders (n = 67, 21.5%; mainly asthenia and pain). More than 1 out of 5 ADRs were 'injury, poisoning and procedural complications' (n = 67), mainly accidental or intentional exposures (n = 44, 14.1%), overdoses (n = 14, 4.5%), or off-label use (n = 11, 3.5%). Overall, 133 (42.8%) reports were 'serious', including 11 deaths. Deaths mainly involved adolescents with intentional overdose and completed suicide with other associated drugs in 75% of reports. Our study identified rare but serious safety issues (rhabdomyolysis, myalgia, and hepatocellular injury). These ADRs can impact quality of life or lead to life-threatening complications in children. Our results should be supplemented with other data sources. Spontaneous statin ADR reports in children to pharmacovigilance networks must be promoted.
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- 2020
8. Does spontaneous adverse drug reactions’ reporting differ between different reporters? A study in Toulouse Pharmacovigilance Centre
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Geneviève Durrieu, Florence Moulis, Haleh Bagheri, Emmanuelle Bondon-Guitton, Jean-Louis Montastruc, and Carole Nicol
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Community pharmacies ,medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,Patients ,business.industry ,Mobile apps ,Retrospective cohort study ,Mandatory Reporting ,Pharmacists ,030226 pharmacology & pharmacy ,Pharmacovigilance ,03 medical and health sciences ,0302 clinical medicine ,Physicians ,Family medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Medicine ,Pharmacology (medical) ,Medical history ,France ,Drug reaction ,business ,Retrospective Studies - Abstract
Summary Introduction In France since 2011, report of adverse drug reactions (ADRs) has been extended to patients (and patients’ associations) who can declare directly ADRs to their regional pharmacovigilance centre. In pharmacovigilance, informativeness of ADRs reports is important to improve signal's detection. The present study was performed to compare the quality of patients’, physicians and community pharmacists’ reports. Methods We performed a retrospective study investigating the quality of patients’, physicians and community pharmacies’ ADRs reported to Toulouse University PharmacoVigilance Centre (TUPVC) from January 2014 to June 2017. We used mandatory and non-mandatory criteria, as defined by European Medicines Agency. Reports’ quality was defined as “satisfactory” when more than 90% of items were completed. We also compared reports’ quality according to ADRs seriousness and the used reporting tools (email or the mobile app VigiBip®). Results The number of reports to TUPVC increased between 2014 and 2016 (+51%) for patients and remained stable for pharmacists and physicians. According to the mandatory criteria, quality of the investigated reports was “satisfactory” (more than 90% of the items filled) whatever the reporter and without significant differences between reporters. For the non-mandatory criteria, clinical description of ADRs and ADRs’ outcome were only filled over 90%. Significant differences were observed between the different reporters: community pharmacists informed better clinical description, ADR outcome and concomitant drugs versus both patients and physicians. Physicians informed better medical history and biological data whereas patients informed medical history and other aetiologies better than pharmacists and clinical description of ADRs better than physicians. Conclusion The present study failed to show differences between pharmacies’, physicians’ and patients’ ADRs reports, for the mandatory criteria. However, significant differences were found for non-mandatory criteria with drug data more filled by pharmacists and medical ones more by physicians and patients.
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- 2019
9. Are lipid‐lowering drugs associated with a risk of cataract? A pharmacovigilance study
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François Montastruc, Haleh Bagheri, Geneviève Durrieu, Margaux Lafaurie, Jean-Louis Montastruc, Fabien Despas, Claire de Canecaude, and Vanessa Rousseau
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Male ,Risk ,medicine.medical_specialty ,medicine.drug_class ,Atorvastatin ,Niacin ,030226 pharmacology & pharmacy ,Cataract ,Pharmacovigilance ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Ezetimibe ,Internal medicine ,medicine ,Humans ,Pharmacology (medical) ,Rosuvastatin ,Aged ,Hypolipidemic Agents ,Alirocumab ,Aged, 80 and over ,Pharmacology ,Bile acid ,business.industry ,Cholesterol ,PCSK9 Inhibitors ,Middle Aged ,Evolocumab ,chemistry ,Simvastatin ,Female ,Hydroxymethylglutaryl-CoA Reductase Inhibitors ,business ,030217 neurology & neurosurgery ,medicine.drug - Abstract
Some reports have raised concerns regarding a potential risk of cataracts associated with statins. However, clinical and observational studies evaluating the risk led to conflicting results. We assessed whether lipid-lowering drugs (LLD) use is associated with an increased risk of cataract using the WHO's Individual Case Safety Reports database, VigiBase® . We performed a disproportionality analysis with all reports between 1/1/1988 and 12/31/2018 to measure the reporting risk of 'cataract' in patients ≥45 years. Primary analysis compared LLD users to non-users. To mitigate some potential confounding bias, we performed several sensitivity analyses excluding reports (i) with an association of at least two LLD, (ii) with antidiabetic and glucocorticoids and (iii) with lovastatin. We also analyzed the data according to the different classes of age limiting the period of study to years 2002-2012. We identified 14 664 reports of cataract (3 049 in LLD users, 66% women, 66 ± 20 years). Statins (84%, atorvastatin, simvastatin, rosuvastatin and lovastatin) were mostly reported, followed by fibrates (5.7%), nicotinic acid (3%), bile acid sequestrants (2%), herbal cholesterol and triglyceride reducers (2%) and others (ezetimibe, PCSK9 inhibitors, 15%). LLD users were associated with a greater risk of reports than non-users (ROR 2.47, 95% CI 2.37-2.57). This association was also found for statins in general, fibrates, bile sequestrants, nicotinic acid, herbal drugs and others. Similar trends were observed in sensitivity analyses (except for fibrates and nicotinic acid after exclusion of reports with at least two LLD or in older patients ≥75 years). Using a large real-life database (>18.5 million reports), we found a signal of cataract for LLD as a whole and statins, bile sequestrants and herbal drugs in particular. The signal disappeared for fibrates and nicotinic acid in older patients. No definite conclusions can be made for ezetimibe or PCSK9 inhibitors (evolocumab and alirocumab). This suggests that a decrease in cholesterol could be important in the pathophysiology of cataract in patients exposed to the main LLD.
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- 2019
10. Adverse Drug Reactions, Iatrogenic Diseases, Drug Safety, and Pharmacovigilance: Importance and Interest for Patients and Their Physicians
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François Montastruc, Haleh Bagheri, Geneviève Durrieu, Isabelle Lacroix, and J. L. Montastruc
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Drug ,medicine.medical_specialty ,business.industry ,media_common.quotation_subject ,Pharmacoepidemiology ,Clinical trial ,Quality of life (healthcare) ,Pharmacogenomics ,Pharmacovigilance ,medicine ,Iatrogenic disease ,Intensive care medicine ,business ,Pharmacogenetics ,media_common - Abstract
Drug monitoring and safety is a daily challenge for clinicians. Pharmacovigilance is the study of adverse-drug reactions and iatrogenic diseases. If not always life-threatening, these reactions can impair patient’s overall and oral well-being and quality of life. Methods for quantifying the risk of drug use are numerous, ranging from experimental pharmacology and toxicology observations to the results of clinical trials and pharmacoepidemiology data. This chapter also underlines the importance of pharmacogenetics and pharmacogenomics approaches.
- Published
- 2021
11. Interest of a general practitioner pharmacovigilance network to provide drug information: A comparative study in France
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Claire de Canecaude, Jean-Louis Montastruc, Geneviève Durrieu, Julien Jacquot, Vanessa Rousseau, 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), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, and CCSD, Accord Elsevier
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Male ,medicine.medical_specialty ,Wilcoxon signed-rank test ,Drug-Related Side Effects and Adverse Reactions ,[SDV]Life Sciences [q-bio] ,education ,030226 pharmacology & pharmacy ,03 medical and health sciences ,Face-to-face ,symbols.namesake ,Pharmacovigilance ,0302 clinical medicine ,General Practitioners ,Medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,Fisher's exact test ,business.industry ,medicine.disease ,3. Good health ,Test (assessment) ,[SDV] Life Sciences [q-bio] ,Outreach ,Clinical research ,Pharmaceutical Preparations ,Family medicine ,symbols ,France ,business ,Adverse drug reaction - Abstract
Summary 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. This additional support is not available to GPs not included in the PV network (NoPMIP-GPs) who have to ask drug questions spontaneously to the TUPVC. Objective The objective of this study was to compare the number and characteristics of drug questions between PMIP-GPs and NoPMIP-GPs. Methods All questions asked by GPs to the TUPVC from 01 Jan 2015 to 31 Dec 2017 were reviewed. Questions were classified into two groups: “general” and “related to a patient”. The “related to a patient” category was divided in three subgroups: “ADRs”, Drug-Drug Interactions and “Drug Management”. Drugs were classified according to anatomical therapeutic chemical (ATC) classification. For comparisons, Wilcoxon test, Chi2 test or Fisher test were used. Results During the study period, the CRA collected 293 questions from the 165 PMIP-GPs. TUPVC received 333 questions asked spontaneously by the 3400 NoPMIP-GPs. PMIP-GPs asked significantly 3 times more questions than NoPMIP-GPs. Most of the GP questions were classified in the “related to a patient” category (74.9%). When we compared the proportion of “related to a patient” to “general” questions, there was no statistically significant difference between PMIP-GPs and NoPMIP-GPs. PMIP-GPs asked more questions about “ADRs”, but less on “Drug Management” and or “Drug-Drug Interactions”. The drugs most frequently involved were amiodarone, rivaroxaban and levothyroxine. Conclusion This is the first study about GPs’ drug-related questions asked to a PV center. We found that an organization, such as a CRA-GP “face to face” visit, increased the number of drug questions. This kind of organization should be developed in order to improve independent drug information outreach.
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- 2020
12. [Completeness of pharmacovigilance reporting in general medicine in France.]
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Xavier, Humbert, Julien, Jacquot, Joachim, Alexandre, Marion, Sassier, Ninon, Robin, Cécile, Pageot, Farid, Kheloufi, Caroline, Joyau, Antoine, Coquerel, Geneviève, Durrieu, and Sophie, Fedrizzi
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Pharmacovigilance ,Drug-Related Side Effects and Adverse Reactions ,General Practitioners ,Adverse Drug Reaction Reporting Systems ,Humans ,France ,Practice Patterns, Physicians' - Abstract
Spontaneous reporting remains one of the cornerstones of post-marketing drug safety surveillance. One of its main limitations is a lack of completeness.The main aim of this study was to assess the completeness of pharmacovigilance reports sent by general practitioners (GPs) to regional pharmacovigilance centers (RPC) reported in the French pharmacovigilance database (FPVD). Secondary aim was to identify factors associated with complete reports.All adverse drugs reactions (ADRs) sent by GPs in France in 2015 were analyzed. According to information provided in ADR reports (ADR, date of occurrence, clinical description, drugs suspected, etc.), completeness was analyzed from#8220;mandatory#8221; criteria (age, gender, ADR#160;and suspected drug(s)) and#8220;non-mandatory#8221; criteria (medical history, concomitant drugs, symptoms evolution and complementary exams) and classified#160;as#160;#8220;well-documented#8221;,#8220;slightly-documented#8221; or#8220;poorly-documented#8221;.In 2015, the FPVD contained 3,020 ADR reports realized by GPs. Only 16.4% of these reports were classified as#8220;well-documented#8221;, in accordance with study criteria. The most poorly documented items were concomitant drugs (41.4%) and complementary exams (37.4%). An association between a#8220;well-documented#8221; ADR report and its#8220;seriousness#8221; (OR = 3,02 [95%#160;CI#160;2,44; 3,23], P#160;lt;#160;10#8211;3) and elderly compared to adults (OR#160;=#160;1,76 [95% CI 1,42; 2,18], P#160;lt;#160;10#8211;3) or children (OR = 4,59 [95% CI 2,51; 8,39], P#160;lt;#160;10#8211;3).Our study shows that only one out of six ADR reports was#8220;well-documented#8221;. It appears to be important to promote pharmacovigilance to improve completeness of ADR reports.
- Published
- 2020
13. Tamoxifen and the risk of Parkinsonism: a case/non-case study
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Justine Benevent, Farzin Khosrow-Khavar, Maryse Lapeyre-Mestre, François Montastruc, Olivier Rascol, Geneviève Durrieu, Marion Montastruc, Christel Renoux, Agnès Sommet, Sibylle de Germay, Vanessa Rousseau, and Jean-Louis Montastruc
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Pharmacology ,Oncology ,medicine.medical_specialty ,business.industry ,Parkinsonism ,Case-control study ,General Medicine ,Odds ratio ,medicine.disease ,030226 pharmacology & pharmacy ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Internal medicine ,Pharmacovigilance ,medicine ,Pharmacology (medical) ,Adverse effect ,business ,030217 neurology & neurosurgery ,Tamoxifen ,Adverse drug reaction ,medicine.drug - Abstract
Three studies have suggested a potential positive association between the use of tamoxifen in breast cancer and Parkinsonism, mainly after long-term exposure. To explore this potential signal, we performed a case/non-case study using the World Health Organization Global Individual Case Safety Reports (ICSRs) database, VigiBase® between 1979 and 2018. Among women ≥ 55 years, we measured the risk of reporting “Parkinsonism” compared with all other adverse drug reactions [as a reporting odds ratio (ROR 95% CI)] for tamoxifen compared to all other drugs or aromatase inhibitors. During the study period, 356 ICSRs of Parkinsonism reported with tamoxifen were identified. We failed to find a positive association between tamoxifen exposure and Parkinsonism in comparison with exposure to other drugs (ROR = 0.79; 95% CI 0.71–0.88) or aromatase inhibitors (ROR = 0.39; 95% CI 0.33–0.46). This study did not find evidence for Parkinsonism associated with tamoxifen.
- Published
- 2018
14. Pharmacovigilance in pediatrics
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Annie Pierre Jonville-Béra, Kristina Star, Émilie Bouquet, and Geneviève Durrieu
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Drug ,Pediatrics ,medicine.medical_specialty ,media_common.quotation_subject ,Pharmacovigilance ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,030225 pediatrics ,Adverse Drug Reaction Reporting Systems ,Humans ,Medication Errors ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,Drug reaction ,Early childhood ,media_common ,business.industry ,Incidence (epidemiology) ,Small sample ,Off-Label Use ,Pharmacoepidemiology ,Clinical trial ,Prenatal Exposure Delayed Effects ,Female ,business - Abstract
The characteristics of pharmacology and drug evaluation in the pediatric age group highlight the necessity for the pharmacovigilance community to adjust to the specific features of children. At the time of marketing a medicinal product intended for children, the product's safety profile is sometimes less well known than for adults due to fewer or small sample clinical trials. Furthermore, the frequent off-labeled drug use, the use of unsuitable dosage forms and the need for continuous dose adjustments increase the risk of medication errors and thus lead to avoidable adverse drug reactions (ADRs). The occurrence of child-specific ADRs (such as growth disorders) or ADRs more commonly occurring in children than in adults make it necessary to monitor the safety of child-specific drugs. Pediatric pharmacovigilance includes also the consequences of in utero exposure, whether manifestations are present from birth or occur in early childhood (such as neurodevelopmental disorders). The incidence of ADRs varies with age, setting of medical care (in- or out-patients, pediatric specialties) and by country in which the study was carried out. The drugs most frequently reported with ADRs are those most commonly used in the pediatric age group, i.e. antibiotics and vaccines. The ADRs most often reported are skin, neurological and general disorders. As in adults, spontaneous notification is essential to generate alerts and child-specific pharmacoepidemiological studies are necessary and should be developed.
- Published
- 2018
15. Tintin in the Land of Drugs: A pharmacological, pharmacovigilance approach
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Justine Benevent, François Montastruc, Jean-Michel Du Plantier, Haleh Bagheri, Jean-Louis Montastruc, Isabelle Lacroix, Christine Damase-Michel, Agnès Sommet, and Geneviève Durrieu
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Drug-Related Side Effects and Adverse Reactions ,Substance-Related Disorders ,business.industry ,Comics ,medicine.disease ,Pharmacovigilance ,Pharmaceutical Preparations ,Literature ,Humans ,Medicine ,Pharmacology (medical) ,Medical emergency ,business - Published
- 2019
16. Adverse Drug Reaction Reports Received Through the Mobile App, VigiBIP®: A Comparison with Classical Methods of Reporting
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François Montastruc, Vanessa Rousseau, Leila Chebane, Christine Damase-Michel, Haleh Bagheri, Geneviève Durrieu, Maryse Lapeyre-Mestre, Isabelle Lacroix, Jean-Louis Montastruc, and Emilie Jouanjus
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Pharmacology ,Drug ,business.industry ,media_common.quotation_subject ,Mobile apps ,MEDLINE ,Toxicology ,medicine.disease ,030226 pharmacology & pharmacy ,03 medical and health sciences ,0302 clinical medicine ,Pharmacovigilance ,Smartphone app ,medicine ,Chi-square test ,Pharmacology (medical) ,030212 general & internal medicine ,Drug reaction ,Medical emergency ,business ,Adverse drug reaction ,media_common - Abstract
The use of mobile apps is increasing in medicine. In pharmacovigilance, mobile apps may help to increase adverse drug reaction reporting and improve the communication of safety issues. The Toulouse University Pharmacovigilance Center has developed VigiBIP®, a free smartphone app available on Android and Apple stores, for reporting adverse drug reactions and requesting drug safety information. The present study was performed to compare the main characteristics of spontaneous adverse drug reaction reports received through VigiBIP® with classical methods of reporting (phone, e-mail, fax, letter, website) during 25 months (2015–17). Using the Chi squared test, we compared the type of reporter, adverse drug reaction seriousness, drugs involved and reported ADRs using VigiBIP® and classical methods of reporting A total of 4102 reports were received by the Toulouse University Pharmacovigilance Center, including 4.7% through VigiBip®. Patients’ reports were significantly more frequent with VigiBip® (6.7%) than with classical methods (3.4%) [p = 0.01]. Reported adverse drug reactions and involved drugs differed according to the method of reporting used. Our study shows that a mobile app is an additional tool used in pharmacovigilance. Types of reporters and adverse drug reactions in VigiBIP were different to those seen in classical methods of reporting.
- Published
- 2017
17. Drugs and Dupuytren’s disease: a pharmacovigilance study in VigiBase®
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Agnès Sommet, Jean-Louis Montastruc, Julia Guion-Firmin, Geneviève Durrieu, Adeline Ruyssens-Witrand, Claire de Canecaude, and Margaux Lafaurie
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Pharmacology ,medicine.medical_specialty ,business.industry ,Pharmacovigilance ,Pharmacology toxicology ,medicine ,MEDLINE ,Pharmacology (medical) ,General Medicine ,Disease ,Intensive care medicine ,business - Published
- 2021
18. Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns
- Author
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Agnès Sommet, Geneviève Durrieu, Anthony Touafchia, François Montastruc, Haleh Bagheri, Laurent Chouchana, and Didier Carrié
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0301 basic medicine ,Microbiology (medical) ,Bradycardia ,medicine.medical_specialty ,030106 microbiology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Tocilizumab ,Internal medicine ,Pharmacovigilance ,medicine ,030212 general & internal medicine ,business.industry ,Hydroxychloroquine ,Lopinavir ,General Medicine ,Odds ratio ,Clinical trial ,Research Note ,Infectious Diseases ,chemistry ,Ritonavir ,medicine.symptom ,business ,medicine.drug - Abstract
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. All reports of patients with COVID-19 registered up to the 23th of September 2020 were included. We conducted disproportionality analyses allowing the estimation of reporting odds ratios (RORs) with 95% Confident Intervals (95% CI). Results We found 302 cardiac effects including 94 bradycardia (31%) among the 2,603 reports with remdesivir prescribed in COVID-19 patients. Most of reports were serious (75, 80%) and in 16 reports (17%) evolution was fatal. Compared with hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids, the use of remdesivir was associated with an increased risk of reporting bradycardia (ROR 1.65; 95% CI 1.23, 2.22). Consistent results were observed in other sensitivity analyses. Conclusions This post-marketing study in a real-world setting suggests that the use of remdesivir is significantly associated with an increased risk of reporting bradycardia and serious bradycardia when compared with the use of with hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids. This result is in line with pharmacodynamic properties of the remdesivir.
- Published
- 2021
19. Atropinic (anticholinergic) burden in antipsychotic-treated patients
- Author
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François Montastruc, Anthony Touafchia, Mélanie Araujo, Leila Chebane, Justine Benevent, Jean-Louis Montastruc, Bernard Bégaud, Christophe Arbus, Geneviève Durrieu, Laurent Schmitt, Emmanuelle Guitton-Bondon, Bordeaux population health (BPH), and Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)
- Subjects
Male ,Time Factors ,Databases, Factual ,medicine.medical_treatment ,030226 pharmacology & pharmacy ,Cholinergic Antagonists ,Cognition ,Drug Utilization Review ,0302 clinical medicine ,Risk Factors ,Drug Interactions ,Pharmacology (medical) ,Child ,media_common ,Aged, 80 and over ,Middle Aged ,3. Good health ,Child, Preschool ,Anesthesia ,Female ,France ,Antipsychotic Agents ,Adult ,Drug ,medicine.medical_specialty ,Adolescent ,medicine.drug_class ,media_common.quotation_subject ,Antiparkinsonians ,Young Adult ,03 medical and health sciences ,Memory ,Internal medicine ,Pharmacovigilance ,medicine ,Anticholinergic ,Adverse Drug Reaction Reporting Systems ,Humans ,Cognitive Dysfunction ,In patient ,Drug reaction ,Medical prescription ,Antipsychotic ,Aged ,PharmacoEpi-Drugs ,Pharmacology ,Memory Disorders ,business.industry ,Infant, Newborn ,Infant ,Cross-Sectional Studies ,Polypharmacy ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business ,030217 neurology & neurosurgery - Abstract
Antipsychotic drugs possess side atropinic (anticholinergic) properties that may induce several adverse drug reactions (ADRs), such as memory loss or cognitive impairment. The aim of the present study was investigating anticholinergic burden in patients treated with antipsychotic drugs. All ADR reports including at least one antipsychotic and registered between 2000 and 2015 in the Midi-Pyrenees PharmacoVigilance Database were extracted and analyzed using the Anticholinergic Duran's list. The primary objective of this cross-sectional study was to calculate anticholinergic burden in antipsychotic-treated patients; the secondary one was to investigate associated factors. Among the 1,948 reports, the average number of atropinic drugs per report was 2.4 +/- 1.4. At least one atropinic drug was found in 59.4% of reports (1,158), in addition to antipsychotic drugs. The mean anticholinergic burden per report was 3.9 +/- 2.9. A value >/= 3 was found in 61.7% of the reports. A significant association between anticholinergic burden, age and male gender of patients was found. The mean value of anticholinergic burden remained stable during the study period. This study showed high values of anticholinergic burden in patients receiving antipsychotics. Thus, considering the potential noxious clinical impact of atropinic properties on cognitive functions, an appropriate approach should be to reduce prescription of antipsychotics with a high anticholinergic burden but also coprescription of other frequently associated atropinic drugs, like antiparkinsonians, H1 antihistamines or imipraminic antidepressants in these patients.
- Published
- 2017
20. Frequency and Nature of Adverse Drug Reactions Due to Non-Prescription Drugs in Children: A Retrospective Analysis from the French Pharmacovigilance Database
- Author
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Vanessa Rousseau, Jean-Louis Montastruc, Emmanuelle Bondon-Guitton, François Montastruc, Mathieu Maupiler, Geneviève Durrieu, and Leila Chebane
- Subjects
Male ,Drug ,Pediatrics ,medicine.medical_specialty ,Prescription drug ,Databases, Factual ,Drug-Related Side Effects and Adverse Reactions ,media_common.quotation_subject ,Nonprescription Drugs ,computer.software_genre ,030226 pharmacology & pharmacy ,Pharmacovigilance ,03 medical and health sciences ,0302 clinical medicine ,Pharmacotherapy ,030225 pediatrics ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,Medical prescription ,Child ,Retrospective Studies ,media_common ,Aspirin ,Database ,business.industry ,Retrospective cohort study ,Amoxicillin ,Pediatrics, Perinatology and Child Health ,Female ,business ,computer ,medicine.drug - Abstract
Studies that evaluate the safety of non-prescription drugs in children remain scarce. The aim of the present study was to compare adverse drug reactions (ADRs) due to prescription versus non-prescription drugs in children. We conducted a retrospective analysis of ADR notifications for a pediatric population (aged
- Published
- 2017
21. Can drugs induce or aggravate sleep apneas? A case-noncase study in VigiBase®, the WHO pharmacovigilance database
- Author
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Leila Chebane, François Montastruc, Geneviève Durrieu, Emmanuelle Bondon-Guitton, Florence Moulis, Vanessa Rousseau, Justine Benevent, Haleh Bagheri, Jean-Louis Montastruc, Agnès Sommet, and Mélanie Linselle
- Subjects
Pharmacology ,Drug ,Database ,Opium alkaloids ,business.industry ,media_common.quotation_subject ,Sleep apnea ,computer.software_genre ,medicine.disease ,030226 pharmacology & pharmacy ,03 medical and health sciences ,0302 clinical medicine ,Pharmacovigilance ,medicine ,Etiology ,Quetiapine ,Pharmacology (medical) ,business ,computer ,030217 neurology & neurosurgery ,Rofecoxib ,Clozapine ,medicine.drug ,media_common - Abstract
The potential favorizing role of drugs in sleep apnea syndrome (SAS) is unknown. This study investigates drugs associated with SAS in a pharmacovigilance database. SAS recorded as adverse drug reactions (ADRs) in VigiBase® , the WHO pharmacovigilance database (more than 11 million reports), from 1978 to 2015 was selected. The risk of SAS reports was estimated using the case-noncase method, with cases being SAS and noncases all other recorded ADRs. During this 37-year period, 3325 ADRs including the word SAS were registered (0.05% of the database). Mean age was 51.2 ± 16.9 years with 52% men. ADRs were 'serious' in around 82% of cases. The case-noncase study found an association between SAS and exposition with sodium oxybate, rofecoxib, quetiapine, and clozapine for individual drugs and coxibs, antipsychotics, benzodiazepines, and opium alkaloids for drug classes. The potential role of other drugs is discussed. This study suggests that SAS can be associated with some drugs (mainly psychotropics) that are able to reveal or aggravate such a disease. Physicians should take into account the role of drugs in the etiological appraisal and management of SAS.
- Published
- 2017
22. Serious adverse drug reactions with hydroxychloroquine: a pharmacovigilance study in Vigibase®
- Author
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Geneviève Durrieu, Vanessa Rousseau, Jean-Louis Montastruc, and Haleh Bagheri
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Adult ,Male ,2019-20 coronavirus outbreak ,medicine.medical_specialty ,Adolescent ,Databases, Factual ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Pharmacology toxicology ,MEDLINE ,Pharmacovigilance ,Young Adult ,Adverse Drug Reaction Reporting Systems ,Humans ,Medicine ,Pharmacology (medical) ,Drug reaction ,Intensive care medicine ,Letter to the Editor ,Aged ,Aged, 80 and over ,Pharmacology ,business.industry ,Hydroxychloroquine ,General Medicine ,Middle Aged ,Antirheumatic Agents ,Female ,business ,medicine.drug - Published
- 2020
23. Myocardial infarction and ischemic stroke with vasoconstrictors used as nasal decongestant for common cold: a French pharmacovigilance survey
- Author
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Margaux Lafaurie, Marina Atzenhoffer, Jean-Louis Montastruc, Kévin Bihan, Charles Khouri, Geneviève Durrieu, and Pascale Olivier
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Adult ,Male ,medicine.medical_specialty ,Pharmacology toxicology ,Myocardial Infarction ,MEDLINE ,Common Cold ,Brain Ischemia ,Pharmacovigilance ,Surveys and Questionnaires ,Internal medicine ,medicine ,Humans ,Vasoconstrictor Agents ,Pharmacology (medical) ,Myocardial infarction ,Administration, Intranasal ,Pharmacology ,business.industry ,Common cold ,General Medicine ,Middle Aged ,medicine.disease ,Stroke ,Nasal decongestant ,Nasal Decongestants ,Ischemic stroke ,Cardiology ,Female ,business - Published
- 2019
24. Liquid formulation of ifosfamide increased risk of encephalopathy: A case-control study in a pediatric population
- Author
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Anne Default, Aurélie Grandvuillemin, Nathalie Massy, Geneviève Durrieu, Mégane Mousset, Marion Allouchery, Marina Babin, Aude Lambert, G. Veyrac, Marie-Blanche Valnet-Rabier, Valérie Gras-Champel, Marie-Christine Zenut, Marion Sassier, Fanny Rocher, Louise Triquet, Paola Sanchez-Pena, Brahim Azzouz, Hélène Géniaux, Corinne Simon, Johana Béné, Florelle Bellet, Dominique Hillaire-Buys, Nadine Petitpain, Marion Lepelley, Hélène Jantzem, Jean-Luc Faillie, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université Grenoble Alpes - UFR Pharmacie (UGA UFRP), Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre Hospitalier Universitaire de Reims (CHU Reims), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Assistance Publique - Hôpitaux de Marseille (APHM), Laboratoire de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Unité de Pharmacoépidémiologie, INSERM 1027, Université de Toulouse, Faculté de Médecine, Centre Hospitalier Universitaire, CHU Toulouse [Toulouse], CHU Limoges, Centre Régional de Pharmacovigilance, de Renseignement sur le Médicament et de Pharmaco épidémiologie de Bourgogne [Dijon], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Amiens-Picardie, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), CHU Strasbourg, Centre d'Investigation Clinique [CHU Rouen] (CIC Rouen), Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Régional de PharmacoVigilance de Lorraine (CRPV Lorraine), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre Hospitalier Universitaire de Nice (CHU Nice), CHU Bordeaux [Bordeaux], 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), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Pontchaillou [Rennes], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Montpellier, Pôle de biologie médicale et d'anatomie pathologique, CHU Clermont-Ferrand, 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), and Normandie Université (NU)
- Subjects
Pediatrics ,medicine.medical_specialty ,Chloroethanamine ,Encephalopathy ,030226 pharmacology & pharmacy ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Pharmacovigilance ,medicine ,Humans ,Pharmacology (medical) ,Ifosfamide ,Child ,Antineoplastic Agents, Alkylating ,Children ,Retrospective Studies ,Brain Diseases ,Liquid formulation ,business.industry ,Case-control study ,Case-control ,[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences ,medicine.disease ,3. Good health ,Residual risk ,Increased risk ,Case-Control Studies ,Observational study ,business ,Chloroethylamine ,medicine.drug ,Pediatric population - Abstract
International audience; 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-year study from spontaneous reports lead to suspect a potential residual risk. Due to the many limitations associated with spontaneous notifications, we performed a multicentric observational study, aiming to better explore this pharmacovigilance signal.METHODS:We performed a case-control study in pediatric oncology Departments of 25 university hospitals between July 1st, 2016 and July 1st, 2018. All children (
- Published
- 2019
25. Methylprednisolone-related liver injury: A descriptive study using the French pharmacovigilance database
- Author
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Aurore Gouraud, Jérôme Dumortier, Véronique Pizzoglio, Corinne Simon, Geneviève Durrieu, Nathalie Bleyzac, Sabrina Pierre, Judith Cottin, Hospices Civils de Lyon (HCL), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Centre Régional de Pharmacovigilance (CRPV), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), 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 Toulouse [Toulouse], Hôpital Edouard Herriot [CHU - HCL], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CCSD, Accord Elsevier, 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
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,Databases, Factual ,[SDV]Life Sciences [q-bio] ,Liver injury ,Gastroenterology ,Methylprednisolone ,03 medical and health sciences ,Route of administration ,Pharmacovigilance ,Young Adult ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Adverse effect ,Child ,Aged ,Autoimmune disease ,Aged, 80 and over ,Hepatology ,business.industry ,Multiple sclerosis ,Infant ,Middle Aged ,medicine.disease ,3. Good health ,[SDV] Life Sciences [q-bio] ,030220 oncology & carcinogenesis ,Concomitant ,Child, Preschool ,030211 gastroenterology & hepatology ,Female ,France ,Safety ,Chemical and Drug Induced Liver Injury ,business ,medicine.drug - Abstract
International audience; Purpose: Hepatotoxicity associated with methylprednisolone (MP) is rarely reported in the literature. The aim of the present study was to review the characteristics of acute liver injury associated with intravenous (IV) or oral MP registered in the French pharmacovigilance database (FPD).Methods: All cases with MP coded as suspected, concomitant, or interacting drug associated with liver injury as the adverse effect reported up to May 2016 were extracted from the FPD. Cases were identified using the "Drug related hepatic disorders" Standard Medical Query.Results: A total of 97 cases of liver injury associated with MP were analysed; 58.8% were women and the median age was 46 years (range: 1-91). MP was used for an autoimmune disease in 47.6% of cases including 26 cases of multiple sclerosis, and was IV in 79.4% of cases. Nearly three-quarters of patients (73,2%) had a hepatocellular type of injury, the severity of which was mainly mild (45%) or moderate (31%). Most patients (92%) spontaneously and fully recovered within a mean 38.4 days. A rechallenge using the IV route was performed in 13 patients and for 10 (76.9%) this was positive (the initial type of injury was hepatocellular for all these cases). Regarding IV route of administration (n=77), MP was coded as the only suspected drug in 22% of cases.Discussion: The results suggest that IV MP causality should be considered in case of acute liver injury while data for oral MP is insufficient; systematic liver monitoring for high-dose IV MP may be recommended.
- Published
- 2019
26. Completeness of Spontaneous Adverse Drug Reaction Reports Sent by General Practitioners to a Regional Pharmacovigilance Centre: A Descriptive Study
- Author
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François Montastruc, Julien Jacquot, Emmanuelle Bondon-Guitton, Vanessa Rousseau, Jean-Louis Montastruc, Mathilde Mège, and Geneviève Durrieu
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,MEDLINE ,Alternative medicine ,Postmarketing surveillance ,Pharmacology ,Toxicology ,030226 pharmacology & pharmacy ,Pharmacovigilance ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,General Practitioners ,Adverse Drug Reaction Reporting Systems ,Humans ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,Practice Patterns, Physicians' ,Child ,Aged ,Aged, 80 and over ,Safety surveillance ,business.industry ,Infant, Newborn ,Infant ,Middle Aged ,medicine.disease ,Benchmarking ,Child, Preschool ,Spontaneous reporting ,Regression Analysis ,Female ,France ,Medical emergency ,Descriptive research ,business ,Adverse drug reaction - Abstract
Spontaneous reporting of adverse drug reactions (ADRs) remains the cornerstone of postmarketing drug safety surveillance (pharmacovigilance); however, one of its main limitations is incomplete data, thus limiting conclusions about causality assessment.The primary aim of this study was to assess the completeness of ADR reports sent by general practitioners (GPs) to regional pharmacovigilance centres and the secondary objective was to identify factors associated with complete ADR reports.All ADR reports sent by GPs to the Midi-Pyrénées Regional Pharmacovigilance Center (Toulouse, France) from 1 January 2010 to 31 December 2013 were reviewed. Healthcare professionals and patients can forward an ADR using either an online form through the Pharmacology Information Bulletin website ( http://www.bip31.fr ) or 'traditional' ADR reports (i.e. email, letter or fax). According to information provided in ADR reports (i.e. patient identification, ADR, date of occurrence, clinical description, drugs, etc.), reports were classified into three groups: 'well-documented', 'slightly documented' or 'poorly documented'. A multivariate logistic regression was performed to investigate potential factors associated with a 'well-documented' ADR report.During the study period, 613 ADR reports were analysed. Among these reports, only 12.7 % were classified as 'well-documented', 68.5 % as 'slightly documented' and 18.8 % as 'poorly documented'. An association between a 'well-documented' ADR report and its 'seriousness' was found (odds ratio = 1.70 [95 % CI 1.04-2.76], p = 0.01). No association between report completeness ('well-documented' report) and GP practice location or mode of ADR reporting was found.The study shows that only one out of eight ADR reports from GPs was 'well-documented'. Therefore, it appears to be important to promote further information being available regarding the data required in ADR reports to optimise the evaluation of drug causality.
- Published
- 2016
27. Pharmacovigilance, risks and adverse effects of self-medication
- Author
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Christine Damase-Michel, Jean-Louis Montastruc, François Montastruc, Isabelle Lacroix, Grégory Pugnet, Aurélia Berreni, Delphine Abadie, Jean-Paul Giroud, Laurent Sailler, Emmanuelle Bondon-Guitton, and Geneviève Durrieu
- Subjects
Risk ,medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,business.industry ,Treatment duration ,Addiction ,media_common.quotation_subject ,Self Medication ,Pharmacology ,030226 pharmacology & pharmacy ,Pharmacovigilance ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Humans ,In real life ,Pharmacology (medical) ,030212 general & internal medicine ,Intensive care medicine ,business ,Adverse effect ,Seriousness ,media_common ,Self-medication - Abstract
Self-medication means resorting to one or more drugs in order to treat oneself without the help of a doctor. This phenomenon is developing fast. In this review, we will discuss the main definitions of self-medication; we will then present a few important characteristics of this therapeutic practice: prevalence, reasons, populations involved and drugs used. Whilst the theoretical risks of self-medication have been abundantly discussed in the literature (adverse effects, interactions, product, dosage or treatment duration errors, difficulty in self-diagnosis, risk of addiction or abuse…), there is in fact very little detailed pharmacovigilance data concerning the characteristics and the consequences of this usage in real life. This study therefore describes the all too rare data that is available: patients, clinical characteristics, "seriousness" and drugs involved in the adverse effects of self-medication. It also discusses leads to be followed in order to minimize medication risks, which are obviously not well known and clearly not sufficiently notified.
- Published
- 2016
28. Pharmacoepidemiological research for the development and evaluation of drugs in pediatrics
- Author
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Geneviève Durrieu, Florentia Kaguelidou, Antonio Clavenna, Centre d'Investigation Clinique 1426 (CIC 1426), Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), 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
- Subjects
Drug Utilization ,medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,[SDV]Life Sciences [q-bio] ,MEDLINE ,030226 pharmacology & pharmacy ,Pediatrics ,03 medical and health sciences ,Pharmacovigilance ,0302 clinical medicine ,Drug Development ,medicine ,Humans ,Pharmacology (medical) ,Medical prescription ,Intensive care medicine ,Child ,business.industry ,Pharmacoepidemiology ,United States ,3. Good health ,Europe ,Clinical research ,Drug development ,Drug and Narcotic Control ,business ,Pediatric population - Abstract
New regulations have come into force in Europe and the US establishing the pediatric development as an integral part of the early development of medicinal products. Parallel to the advances in pediatric clinical research, it became obvious that all available sources and research tools to gather valuable information for the safe and efficacious prescription of medicines in children should be used. Real-life, pharmacoepidemiological studies provide information that contribute to the better knowledge of drug utilization, effects and safety in the pediatric population and thereby, a better prescribing in children. In this paper, we suggest some possible applications, provide examples of impact of pharmacoepidemiological and pharmacovigilance studies and expose future perspectives in pediatric pharmacoepidemiology.
- Published
- 2018
29. Eur J Clin Pharmacol
- Author
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Vanessa Rousseau, François Montastruc, Geneviève Durrieu, Jean-Luc Faillie, Louise Gaboriau, Florence Moulis, Amandine Gouverneur, Jean-Louis Montastruc, Leila Chebane, Bordeaux population health (BPH), and Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)
- Subjects
Adult ,Male ,medicine.medical_specialty ,Pharmacology toxicology ,MEDLINE ,Tetrazoles ,030204 cardiovascular system & hematology ,030226 pharmacology & pharmacy ,03 medical and health sciences ,Angiotensin Receptor Antagonists ,Pharmacovigilance ,0302 clinical medicine ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,Drug reaction ,Intensive care medicine ,Aged ,Retrospective Studies ,Pharmacology ,Aged, 80 and over ,PharmacoEpi-Drugs ,business.industry ,Aminobutyrates ,Biphenyl Compounds ,General Medicine ,Middle Aged ,Drug Combinations ,Valsartan ,Female ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,France ,business ,Sacubitril, Valsartan - Published
- 2018
30. Adverse Drug Reaction Reports Received Through the Mobile App, VigiBIP
- Author
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François, Montastruc, Haleh, Bagheri, Isabelle, Lacroix, Christine, Damase-Michel, Leila, Chebane, Vanessa, Rousseau, Emilie, Jouanjus, Maryse, Lapeyre-Mestre, Geneviève, Durrieu, and Jean-Louis, Montastruc
- Subjects
Male ,Pharmacovigilance ,Databases, Factual ,Drug-Related Side Effects and Adverse Reactions ,Health Personnel ,Adverse Drug Reaction Reporting Systems ,Humans ,Female ,Mobile Applications - Abstract
The use of mobile apps is increasing in medicine. In pharmacovigilance, mobile apps may help to increase adverse drug reaction reporting and improve the communication of safety issues. The Toulouse University Pharmacovigilance Center has developed VigiBIPThe present study was performed to compare the main characteristics of spontaneous adverse drug reaction reports received through VigiBIPUsing the Chi squared test, we compared the type of reporter, adverse drug reaction seriousness, drugs involved and reported ADRs using VigiBIPOur study shows that a mobile app is an additional tool used in pharmacovigilance. Types of reporters and adverse drug reactions in VigiBIP were different to those seen in classical methods of reporting.
- Published
- 2017
31. [Satisfaction of a pharmacovigilance declaration support network in general practice]
- Author
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Damien, Driot, Lucile, Figuet, Jordan, Birebent, Sandra, Coste, Geneviève, Durrieu, Julien, Jacquot, and Michel, Bismuth
- Subjects
Adult ,Male ,Drug-Related Side Effects and Adverse Reactions ,Primary Health Care ,General Practice ,Personal Satisfaction ,Middle Aged ,Community Networks ,Pharmacovigilance ,General Practitioners ,Surveys and Questionnaires ,Adverse Drug Reaction Reporting Systems ,Humans ,Female ,France - Abstract
General practitioners (GPs) report little adverse drug reactions (ADR), although it is mandatory in France. The objective was to evaluate the satisfaction of the GPs who participated to a pharmacovigilance ADR declaration support network via a clinical research assistant (CRA) moving to their GP office in the French South-West region of Midi-Pyrénées.A satisfaction questionnaire was sent to the 59 active GPs of this network in November 2016.A total number of 44 GPs responded to the survey (mean age 44±11years; 48% of women). The overall satisfaction grade was rated 9/10 (SD±1). The personalized help from a CRA was highly appreciated (n=39; 89%), reduced time-loss (n=35; 90%), and facilitated communication with the local pharmacovigilance department (n=33; 85%). Most GP (95%; n=35) stated that they would keep reporting ADRs, 83% (n=35) stated to declare ADRs via the CRA, the others stated to declare ADRs directly to the Regional Pharmacovigilance Center, mainly via numerical or online tools. For 59% (n=26) their participation to the network had a positive impact on their relationship with patients through the improvement of their vigilance to ADR.Most of the active GP answered. They were very satisfied of the pharmacovigilance CRA network helping ADR reports. It may corroborate the increase of ADRs reporting in Midi-Pyrénées since this network was set up.
- Published
- 2017
32. Use of administrative hospital database to identify adverse drug reactions in a Pediatric University Hospital
- Author
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Emmanuelle Bondon-Guitton, Vanessa Rousseau, Geneviève Durrieu, J.-L. Montastruc, A. Batz, and D. Petiot
- Subjects
Male ,medicine.medical_specialty ,Adolescent ,Databases, Factual ,computer.software_genre ,Hospitals, University ,Pharmacovigilance ,Administrative database ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,Drug reaction ,Child ,Medicine use ,Pharmacology ,Database ,business.industry ,Incidence (epidemiology) ,General Medicine ,Hospitals, Pediatric ,University hospital ,Confidence interval ,Child, Preschool ,Emergency medicine ,Antineoplastic Drugs ,Female ,France ,business ,computer - Abstract
The aim of the study was to detect adverse drug reactions (ADRs) in pediatric inpatients using the medical administrative database “Programme de Medicalisation des Systemes d′Information” (PMSI) and to compare these cases ADRs with those spontaneously reported to a regional PharmacoVigilance (PV) Centre. The study was conducted from January 2008 to December 2011 in the Children University Hospital of Toulouse (Midi-Pyrenees, South-west France). From PMSI database, all discharge summaries including selected ICD-10 codes (10th International Classification of Diseases) were analyzed. All ADRs spontaneously reported by the Children Hospital of Toulouse and registered in the French PV Database (FPVDB) were included. The capture–recapture method was applied to estimate the incidence of ADRs. During the study period, we identified 60 reports from the PMSI database and 200 from the FPVDB. The rate of “serious” ADRs was higher in PMSI reports (74.6 % vs 38.9 %, p
- Published
- 2014
33. Online Reporting of Adverse Drug Reactions: A Study from a French Regional Pharmacovigilance Center
- Author
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Geneviève Durrieu, Delphine Abadie, Leyla Chebane, Jean-Louis Montastruc, and Max Bert
- Subjects
Drug-Related Side Effects and Adverse Reactions ,Health Personnel ,media_common.quotation_subject ,Disclosure ,Pharmacovigilance ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,Drug reaction ,Retrospective Studies ,media_common ,Internet ,Health professionals ,business.industry ,Professional Practice ,Retrospective cohort study ,medicine.disease ,Adr reporting ,Current practice ,Spontaneous reporting ,France ,Medical emergency ,business ,Seriousness - Abstract
Background In France, online reporting via a website is a new method for notifying adverse drug reactions (ADRs). The French Midi-Pyrenees Regional Pharmacovigilance Center (RPVC) set up in July, 2010 a Web-based ADR reporting tool in order to improve ADR reporting rate. Objectives To assess feasibility, use and performances of this new ADR reporting system. To evaluate the main characteristics of these online reports. Methods In a retrospective study, we evaluated characteristics (numbers, ADR reporting and file processing times, type of reporters, suspected drugs, “seriousness” and nature of ADRs) of online notifications reported to the RPVC between July 7th, 2010 (first online notification) and December 31th, 2011. We performed comparisons to a random sample of “conventional” notifications, i.e. spontaneously reported to the RPVC via traditional tools (post, fax, e-mail or telephone) during the same period. Results The total number of online reports was 312 over the 18-month period. There was a 45% increase in numbers of reports from ambulatory healthcare professionals after the implementation of the new reporting tool. Online reports were transmitted to the French Medicine Agency on average almost one month (26 days) earlier than “conventional” ones. This difference was mainly due to a faster ADR notification process via the online form (on average, the reporting period was decreased by 19 days with the new tool). In comparison to “conventional” notifications, online reports came more often from ambulatory healthcare professionals, and involved more frequently neuropsychiatric drugs and neuropsychiatric ADRs. None difference was observed for “seriousness” of ADRs. Conclusions It is feasible to deploy an online ADR reporting system used by health professionals in current practice. We underline the efficiency of this new online reporting tool for increasing ADRs reporting. Moreover, this is the first published study demonstrating that an online reporting tool can help to save time on the ADR reporting period and file processing, which is essential to generate early safety signals.
- Published
- 2014
34. Risk of diabetes associated with statins and fibrates and their association: A disproportionality analysis using the WHO spontaneous reporting database, Vigibase®
- Author
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Vanessa Rousseau, Jean-Louis Montastruc, G. Montastruc, Geneviève Durrieu, Agnès Sommet, François Montastruc, and Justine Benevent
- Subjects
Drug ,Fenofibrate ,Database ,business.industry ,medicine.drug_class ,media_common.quotation_subject ,Atorvastatin ,Odds ratio ,Fibrate ,medicine.disease ,computer.software_genre ,Diabetes mellitus ,Pharmacodynamics ,Pharmacovigilance ,Medicine ,Cardiology and Cardiovascular Medicine ,business ,computer ,media_common ,medicine.drug - Abstract
Relations between hypolipidemic drugs and diabetes are discussed. The aim of our study was to assess the association between diabetes and use of statins or fibrates or their association using the World Health Organization (WHO) global individual case safety reports database, VigiBase®, which records reports from over 130 countries worldwide. We performed a disproportionality analysis including all reports until the 31st December 2017 to measure the risk of reporting “new onset of diabetes” compared with all other reports [as a reporting odds ratio (ROR 95% CI)] for statins, fibrates and their association. The likelihood that diabetes resulted from statin-fibrate pharmacodynamic interaction was also estimated. According to the interaction additive model, a ROR value for coexposure exceeding the sum of the RORs estimated for each individual class of drug supports a potential drug-drug interaction (DDI). To assess the stability of our results, we performed several sensitivity analyses, according to outcome definition and excluding reports with drugs known to induce hyperglycaemia or diabetes. We identified 7633 cases of diabetes (mainly with atorvastatin) and 169,690 non-cases among reports with statins alone, 189 cases (mainly with fenofibrate) and 18,960 non-cases among reports with fibrates alone with 60 cases and 3,187 among reports with the combination statin-fibrates. Statin use alone was associated with an increase in the ROR of diabetes (ROR = 1.75 [1.72–1.78]), but not with fibrate use alone (ROR = 0.76 [0.71–0.82]). The combination of statin + fibrate was associated with an increase in the ROR of diabetes (ROR = 1.46 [1.28–1.67]) but was not significant to support a DDI. Similar results were found in sensitivity analyses. Using the WHO pharmacovigilance database, our study confirmed the signal of diabetes with statins but failed to find any potential signal with fibrates alone and did not suggest a pharmacodynamic DDI with the use of statin + fibrate.
- Published
- 2019
35. Adverse drug reactions in patients with Alzheimer's disease and related dementia in France: a national multicentre cross-sectional study
- Author
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Claire Guy, Marie-Josèphe Jean-Pastor, Isabelle Ingrand, Marie-Laure Laroche, Marie-Christine Perault-Pochat, Fati Nourhashemi, Annie-Pierre Jonville-Béra, Jean-Pierre Charmes, Isabelle Merlet-Chicoine, Louis Merle, Ghada Miremont-Salamé, Anne Castot-Villepelet, Geneviève Durrieu, Carmen Kreft-Jais, and Valérie Gras
- Subjects
medicine.medical_specialty ,education.field_of_study ,Epidemiology ,Cross-sectional study ,business.industry ,Population ,Disease ,Pharmacoepidemiology ,medicine.disease ,3. Good health ,Iatrogenesis ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Pharmacovigilance ,medicine ,Dementia ,Pharmacology (medical) ,030212 general & internal medicine ,Psychiatry ,education ,business ,030217 neurology & neurosurgery ,Adverse drug reaction - Abstract
Purpose To assess the prevalence of adverse drug reactions (ADRs) occurring in patients with Alzheimer’s disease (AD) or other dementia in France. Methods A cross-sectional multicentre study was conducted by the French network of the 31 regional pharmacovigilance centres on a given day. The subjects were selected by random draw to be a representative sample of French patients with dementia: consultations of dementia clinics, nursing-homes, acute and long care geriatric units, rehabilitation care geriatric units. The staff of each medical structure together with that of the pharmacovigilance centre defined a day for including the patients. Socio-demographic data, history, ADR and drugs given were registered. Results There were 1332 subjects included, 51.1% living at home, 48.8% in institutions, aged 82.08.0years (46–108); 61.3% suffered from AD. Meannumber of drugs was 6.33.1. Anti-dementia drugs were given to66.4%subjects. ADR prevalence was 5.0%(95% CI: 3.9–6.2) without a significant difference between at home and institutionalized patients. ADR consisted of gastro-intestinal (23.2%), central nervous system (17.4%) and psychiatric disorders (8.7%). Of the ADR, 31.9% were serious, and 47.8% preventable. The drugs most often involved were anti-dementia (28.9%), cardio-vascular (28.9%) and psychotropic drugs (26.4%, anxiolytics, hypnotics, antidepressants, neuroleptics). Conclusion This national scale study showed that iatrogenesis in patients with AD and related dementia can at times be serious and preventable. Therefore, special attention is required when prescribing psychotropic and anti-dementia drugs, as they are frequently used and induce half of the ADR in this population. Copyright © 2013 John Wiley & Sons, Ltd. key words—Alzheimer’s disease; dementia; adverse drug reaction; pharmacovigilance; cross-sectional study; pharmacoepidemiology
- Published
- 2013
36. Effets indésirables « graves » du tramadol : bilan 2010-2011 de pharmacovigilance en France
- Author
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Jean-Louis Montastruc, Delphine Abadie, Geneviève Durrieu, Anne Roussin, and le Réseau Français des Centres Régionaux de Pharmacovigilance
- Subjects
medicine.medical_specialty ,business.industry ,Analgesic ,Propoxyphene ,Peripheral edema ,Hypoglycemia ,medicine.disease ,Surgery ,Opioid ,Internal medicine ,Pharmacovigilance ,medicine ,Pharmacology (medical) ,Tramadol ,medicine.symptom ,Hyponatremia ,business ,medicine.drug - Abstract
Objective Tramadol is a weak opioid used as a step 2 analgesic, approved in France for moderate to severe pain. After dextropropoxyphene withdrawal, a national pharmacovigilance follow-up of tramadol was decided by the French Drug Agency. Methods All Serious Adverse Drug Reactions (SADR) notified with tramadol to the French PharmacoVigilance Centres (CRPV) and pharmaceutical companies between August 1(st), 2010 and July 31(th), 2011 were analyzed. Results During the study period, 296 cases of SADR were notified to CRPV and 59 to pharmaceutical companies. Apart from opiate-related SADR, tramadol induced serotoninergic SADR, including seizures or serotoninergic syndromes. Several « unlabelled » SADR were also identified: some of them, like hyponatremia or hypoglycemia, are poorly known by health professionals. Other were never published: peripheral edema or pancreatitis. Conclusion This study shows that besides well-known opioid or serotoninergic ADR, tramadol can also induce 2 other relatively unknown ADR: hypoglycemia and hyponatremia.
- Published
- 2013
37. Can drugs induce or aggravate sleep apneas? A case-noncase study in VigiBase
- Author
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Mélanie, Linselle, Agnès, Sommet, Emmanuelle, Bondon-Guitton, Florence, Moulis, Geneviève, Durrieu, Justine, Benevent, Vanessa, Rousseau, Leila, Chebane, Haleh, Bagheri, François, Montastruc, and Jean-Louis, Montastruc
- Subjects
Male ,Pharmacovigilance ,Sleep Apnea Syndromes ,Databases, Factual ,Drug-Related Side Effects and Adverse Reactions ,Pharmaceutical Preparations ,Adverse Drug Reaction Reporting Systems ,Humans ,Female ,Middle Aged ,World Health Organization - Abstract
The potential favorizing role of drugs in sleep apnea syndrome (SAS) is unknown. This study investigates drugs associated with SAS in a pharmacovigilance database. SAS recorded as adverse drug reactions (ADRs) in VigiBase
- Published
- 2016
38. Neurological and digestive bleeding with Direct Oral Anticoagulants versus Vitamin K Antagonists: The differences do not stop there! A pharmacovigilance study
- Author
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Vanessa Rousseau, Jean-Louis Montastruc, Leila Chebane, Geneviève Durrieu, Emmanuelle Bondon-Guitton, A. Cabarrot, François Montastruc, Florence Moulis, and Haleh Bagheri
- Subjects
Pharmacology ,Central Nervous System ,Gastrointestinal tract ,Vitamin K ,Databases, Factual ,business.industry ,Anticoagulants ,Hemorrhage ,030204 cardiovascular system & hematology ,Vitamin k ,medicine.disease ,Gastrointestinal Tract ,03 medical and health sciences ,Pharmacovigilance ,0302 clinical medicine ,Anesthesia ,medicine ,Humans ,030211 gastroenterology & hepatology ,France ,business ,Adverse drug reaction - Published
- 2016
39. Importance of cytochrome P450 (CYP450) in adverse drug reactions due to drug–drug interactions: a PharmacoVigilance study in France
- Author
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François Montastruc, Agnès Sommet, Haleh Bagheri, Anne Charlotte Danton, Maryse Lapeyre-Mestre, Geneviève Durrieu, Jean-Louis Montastruc, and Emmanuelle Bondon-Guitton
- Subjects
Adult ,Male ,Drug ,Adolescent ,Databases, Factual ,Drug-Related Side Effects and Adverse Reactions ,media_common.quotation_subject ,Pharmacology toxicology ,MEDLINE ,Pharmacology ,Pharmacovigilance ,Cytochrome P-450 Enzyme System ,Adverse Drug Reaction Reporting Systems ,Humans ,Medicine ,Drug Interactions ,Pharmacology (medical) ,Drug reaction ,Aged ,media_common ,Aged, 80 and over ,biology ,business.industry ,Cytochrome P450 ,General Medicine ,Middle Aged ,Isoenzymes ,biology.protein ,Female ,France ,business - Abstract
Our aim was to characterize Adverse Drug Reactions (ADRs) related to drug-drug interactions (DDIs) related to involvement of cytochrome P450 (CYP450) isoenzymes in a pharmacovigilance database.ADRs recorded by Midi-Pyrénées PharmacoVigilance center (France) between 1 January and 31 August 2008 were extracted from the French PharmacoVigilance Database (FPVD).Among the 1,205 reported ADRs, 16 (1.3 %), can be explained by involvement of CYP450 isoenzymes (including 4 "serious"). All interactions involved CYP inhibitors, mainly for CYP3A4/5.The percentage of ADRs reported in the pharmacovigilance database and related to CYP450-induced DDIs appears to be relatively low (~ 1-2 %).
- Published
- 2012
40. Trends of reporting of ‘serious’vs. ‘non-serious’ adverse drug reactions over time: a study in the French PharmacoVigilance Database
- Author
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Haleh Bagheri, Maryse Lapeyre-Mestre, Jean-Louis Montastruc, Agnès Sommet, Geneviève Durrieu, and Guillaume Moulis
- Subjects
Pharmacology ,Drug ,business.industry ,media_common.quotation_subject ,Spontaneous reporting ,Environmental health ,Pharmacovigilance ,Linear relation ,Medicine ,Pharmacology (medical) ,Drug reaction ,business ,Prescribed drugs ,Seriousness ,Linear trend ,media_common - Abstract
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Several factors are known to influence spontaneous reporting of adverse drug reactions (ADRs). Among them, ‘seriousness’ of the reaction is one of the most important. • However, evolution in the reporting of ‘serious’vs.‘non-serious’ ADRs over time for the same drug remains unknown. WHAT THIS STUDY ADDS • Spontaneous reports mainly involve ‘non-serious’ ADRs during the first years of marketing and ‘serious’ ADRs later, particularly for drugs with non-hospital use. AIM To investigate trends in spontaneous reporting to the French Pharmacovigilance system of ‘serious’ (SADRs) and ‘non-serious’ (NSADRs) adverse drug reactions over time. METHODS Annual SADR : NSADR ratios were calculated for each drug and their evolution tested with linear trend tests. RESULTS Among the 39 new active substances commercialized in France in 2000, 16 had sufficient data to perform linear trend tests. An increasing linear relation was found for five widely prescribed drugs, a non-significant increasing trend for eight others, i.e. drugs mostly used in hospitals. CONCLUSION ADR reports mainly concern NSADRs during first years of marketing. Reports of SADRs are proportionally more frequent later.
- Published
- 2012
41. [Improving adverse drug reaction reporting by general practitioners through clinical research assistants visits]
- Author
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Geneviève, Durrieu, Julien, Jacquot, Dominique, Baudrin, Mathilde, Mège, Vanessa, Rousseau, Haleh, Bagheri, Emmanuelle, Bondon-Guitton, Delphine, Abadie, François, Montastruc, Michel, Bismuth, Stéphane, Oustric, and Jean-Louis, Montastruc
- Subjects
Adult ,Aged, 80 and over ,Male ,Adolescent ,Drug-Related Side Effects and Adverse Reactions ,Infant ,Pilot Projects ,Middle Aged ,Research Personnel ,Pharmacovigilance ,Young Adult ,General Practitioners ,Child, Preschool ,Adverse Drug Reaction Reporting Systems ,Humans ,Female ,France ,Child ,Aged - Abstract
The main limitation of adverse drug reactions (ADRs) reporting, particularly by general practitioners (GP), to the regional pharmacovigilance centers is under-reporting. The Midi-Pyrénées Regional Pharmacovigilance Center (South western, France) sets up regular visits by a clinical research assistant (CRA) to GP in order to increase the number of ADR reports. The aim of this pilot study was to assess the effect of regular visits of a CRA in GPs offices on the rate of ADR reporting. After one year, CRA visits permit a two-fold increase in ADR reporting.
- Published
- 2015
42. A comparative study of adverse drug reactions during two heat waves that occurred in France in 2003 and 2006
- Author
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Maryse Lapeyre-Mestre, Agnès Sommet, Geneviève Durrieu, and Jean-Louis Montastruc
- Subjects
medicine.medical_specialty ,education.field_of_study ,Epidemiology ,business.industry ,Antiparkinsonians ,Population ,Pharmacology ,Pharmacoepidemiology ,Heat wave ,Internal medicine ,Pharmacovigilance ,Medicine ,Pharmacology (medical) ,In patient ,Drug reaction ,business ,education - Abstract
Purpose Heat waves could reveal or aggravate several ‘serious’ adverse drug reactions (ADRs) in elderly. Thus, we wanted to describe the main characteristics of heat-related ‘serious’ ADRs occurred in patients older than 70 years during these two events in France (2003 and 2006). Methods We analysed ‘serious’ ADRs reported to the network of French pharmacovigilance centres in summer 2003 and 2006 and suspected to be heat related. ‘Serious’ ADRs occurred during summers with heat waves (2003 and 2006) were compared with ADRs occurred during the same months in the summers of 2004 and 2005 (reference period). Results Patients' characteristics and number of ‘serious’ ADRs were similar whatever the year of the study. Number of drug-related deaths seemed higher in 2003 than in 2004–2005. More ‘serious’ heat-related ADRs were reported in the summers of 2003 and 2006 (68 in 2003 and 72 in 2006). Comparing with the reference period, metabolic ADRs were less frequent during the summers of 2003 (29%, p = 0.0001) and 2006 (39%, p = 0.003). Occurrence of other ADRs was similar whatever the period. Drugs more frequently involved during heat waves were diuretics, serotonic antidepressants, angiotensin converting inhibitors and proton pump inhibitors. Differences between 2003 and 2006 were found for non-dopaminergic (atropinic) antiparkinsonians or antiepileptics (most frequently involved in 2006) and beta-blockers or proton pump inhibitors (less frequently involved in 2006). Conclusion The present study underlines the interest of a National Pharmacovigilance Database to follow each year the role of drugs in heat-related ADRs. This survey should be associated with other pharmacoepidemiological methods, such as case–control or population-based studies. Copyright © 2011 John Wiley & Sons, Ltd.
- Published
- 2011
43. The importance of drug–drug interactions as a cause of adverse drug reactions: a pharmacovigilance study of serotoninergic reuptake inhibitors in France
- Author
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Eric Bui, Agnès Sommet, Jean-Louis Montastruc, Laurent Schmitt, Geneviève Durrieu, Emmanuelle Bondon-Guitton, Maryse Lapeyre-Mestre, François Montastruc, and Haleh Bagheri
- Subjects
Adult ,Male ,Drug ,medicine.medical_specialty ,media_common.quotation_subject ,Poison control ,Hemorrhage ,Citalopram ,Pharmacology ,Pharmacovigilance ,Fibrinolytic Agents ,Fluoxetine ,Internal medicine ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Escitalopram ,Drug Interactions ,Pharmacology (medical) ,Confusion ,Diuretics ,media_common ,Psychotropic Drugs ,business.industry ,Age Factors ,General Medicine ,Angiotensin II ,Antidepressive Agents ,Antidepressant ,Female ,France ,business ,Selective Serotonin Reuptake Inhibitors ,Hyponatremia ,medicine.drug - Abstract
To quantify the importance of drug–drug interactions (DDIs) in the occurrence of adverse drug reactions (ADRs) reported with serotoninergic reuptake inhibitors in a pharmacovigilance database. All spontaneous reports of ADRs registered in 2008 by the Midi-Pyrenees PharmacoVigilance Centre that contained mention of one of the serotoninergic reuptake inhibitor (SRI) antidepressants marketed in France were reviewed. DDIs were identified according to the French National Drug Formulary (Vidal) and the interaction supplement of the French independent drug bulletin La Revue Prescrire. ADRs explained by DDIs were characterised. Among the 2,101 spontaneous reports recorded, 177 involved at least one SRI antidepressant. Among the 156 ADRs with at least one theoretical DDI, 41% (95% confidence interval 34–49%) could be explained by a DDI. The most frequent antidepressant involved in DDIs was escitalopram, followed by fluoxetine and citalopram. Among the 65 ADRs related to DDIs, 37 (52.9%) were “serious”, mainly bleedings, confusion and falls, hyponatremia and serotoninergic syndromes. The most frequent drug interactions occurred with psychotropics (antipsychotics, benzodiazepines, among others), followed by antithrombotic agents (antagonists of vitamin K, antiplatelets), diuretics and angiotensin II antagonists. The group with ADRs related to DDIs was older than the group with ADRs not related to DDIs. ADRs were threefold more “serious” in the case of DDIs. Around 40% of ADRs reported with SRIs were related to DDIs. Most of these occurred after association with psychotropics, antithrombotics, or diuretics, especially in the elderly.
- Published
- 2011
44. Perception of risk of adverse drug reactions: a 3-year follow-up of a cohort of medical students
- Author
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Christine Damase-Michel, Jean-Louis Montastruc, C. Hurault, and Geneviève Durrieu
- Subjects
Pharmacology ,Drug ,Aspirin ,medicine.medical_specialty ,business.industry ,medicine.drug_class ,media_common.quotation_subject ,education ,Anticoagulant ,Drug class ,Pill ,Internal medicine ,Pharmacovigilance ,Medicine ,Pharmacology (medical) ,Risk factor ,business ,media_common ,medicine.drug ,Cohort study - Abstract
Previous studies have pointed out the question of effective training and information to health professionals on pharmacovigilance. The lack of training is known to induce inadequate use of drugs and noncompliance of patients. Pharmacology teaching is performed in the third year of medical studies at the Toulouse Faculty of Medicine. The aim of the study was to investigate the perception of risk of adverse drug reactions (ADRs) by medical students at the end of the one year pharmacology course and two years later, after clinical training period. Sixty-seven students were interviewed in May 2005 and in October 2007. Visual analogue scales were used to define a score of perceived risk of ADRs associated with each drug class (ranking from 0 to 10) before and after pharmacology training. The drug classes evaluated were antibiotics, anticoagulants, antidepressants, aspirin, contraceptive pill, corticosteroids, drugs for arterial hypertension, drugs for diabetes (other than insulin), hypnotics, hypocholesterolaemic drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), postmenopausal hormone replacement therapy and tranquilisers. After pharmacology courses (May 2005), antidepressants were ranked as the most dangerous drugs by medical students [median score (25th-75th centiles): 7.7 (6.3-8.6)], followed by anticoagulants [7.6 (6.6-8.4)] and hypnotics [7.4 (6.1-8.1)]. Contraceptive pills was listed in the last position [median score [4.7 (2.2-6.7)]. Two years later (October 2007), anticoagulants moved into the first position [8.3 (7.3-9.2)], followed by NSAIDs [6.9 (5.0-8.4)] and aspirin [6.8 (5.8-8.4)]. Contraceptive pills remained in the last position. No change was observed for NSAIDs and aspirin, still ranked as dangerous drugs by medical students after clinical training. Values of perceived risk were significantly increased for anticoagulant (+9.2%, P < 0.01) and hypoglycemiant drugs (+27.7%, P < 0.0001). The perceived risk significantly decreased for hypocholesterolaemic (-14.3%, P < 0.0001) and antidepressant drugs (-19.5%, P < 0.0001), but not for hypnotics. The study shows that the perception of risk of ADRs by medical students was modified after clinical training. They were still aware of potentially serious ADRs associated with anticoagulants, aspirin or NSAIDs, but they remained less cautious for drugs such as antidepressants. Additional pharmacology training at the end of medical studies will be useful.
- Published
- 2009
45. Neuropathies médicamenteuses : analyse de la Banque française de pharmacovigilance de 1995 à 2005
- Author
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Jean-Louis Montastruc, Isabelle Lacroix, Agnès Sommet, Geneviève Durrieu, Jean-Michel Senard, and Pascale Olivier
- Subjects
Gynecology ,medicine.medical_specialty ,Injury control ,Accident prevention ,business.industry ,Pharmacovigilance ,Poison control ,Medicine ,General Medicine ,business - Abstract
Resume Introduction Les neuropathies medicamenteuses concernent le plus souvent des neuropathies subaigues, sensitives a predominance distale et inferieure. Peu d’etudes pharmacoepidemiologiques sur ces neuropathies ont ete realisees. Methode Nous avons analyse les notifications spontanees de neuropathie peripherique dans la Banque francaise de pharmacovigilance sur une periode de 10 ans. Resultats Nous avons retrouve 1 110 notifications entre janvier 1995 et avril 2005. Elles concernaient des patients de predominance masculine (60 %) avec un âge moyen de 53,6 ans. La plupart des observations concernaient des neuropathies peripheriques sensitives. Cinq cent trente (48 %) des neuropathies etaient « graves ». Les medicaments dermatologiques ont ete a l’origine de neuropathies « graves » dans 85,7 % des cas. Les medicaments imputes etaient par ordre decroissant : les anti-infectieux (43,6 %), les antineoplasiques et immunomodulateurs (15,9 %), les medicaments du systeme cardiovasculaire (14,8 %), les medicaments du systeme nerveux central (7,9 %) puis les medicaments des voies digestives et du metabolisme (4,8 %). Les principes actifs le plus souvent retrouves etaient par ordre decroissant : stavudine (198 cas), didanosine (134), lamivudine (124), thalidomide (57), ritonavir (55), zalcitabine (53) et amiodarone (47). Cette etude a aussi permis de discuter le lien possible entre 2 medicaments (allopurinol et acetate de flecainide) et la survenue de neuropathies peripheriques. Discussion Ce travail souligne l’interet de la declaration des effets indesirables medicamenteux aux centres regionaux de pharmacovigilance, a la fois pour une approche de la frequence relative des medicaments suspects et pour l’alerte concernant des medicaments auparavant non tenus pour responsables.
- Published
- 2008
46. Adverse Drug Reactions and Off-Label Drug Use in Paediatric Patients: A One-Year Survey of the French Pharmacovigilance Database
- Author
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Jean-Louis Montastruc, Geneviève Durrieu, and V. Raoul
- Subjects
Pharmacology ,medicine.medical_specialty ,business.industry ,Pharmacology toxicology ,Toxicology ,Off-label use ,Pharmacovigilance ,medicine ,Pharmacology (medical) ,Drug reaction ,Intensive care medicine ,business ,Paediatric patients - Published
- 2008
47. HMG CoA Reductase Inhibitors and impotence: Results of a Case/Noncase study in the French PharmacoVigilance Database
- Author
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Geneviève Durrieu, E. Huyghe, Catherine Do, Haleh Bagheri, and J.-L. Montastruc
- Subjects
Pharmacology ,biology ,business.industry ,HMG-CoA reductase ,Pharmacology toxicology ,Pharmacovigilance ,biology.protein ,Medicine ,Pharmacology (medical) ,Toxicology ,business - Published
- 2008
48. Perception of risk of adverse drug reactions by medical students: influence of a 1 year pharmacological course
- Author
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Christine Damase-Michel, C. Hurault, V. Bongard, Jean-Louis Montastruc, and Geneviève Durrieu
- Subjects
Pharmacology ,Drug ,medicine.medical_specialty ,business.industry ,media_common.quotation_subject ,education ,Risk perception ,Drug class ,Pill ,Internal medicine ,Cohort ,Pharmacovigilance ,medicine ,Pharmacology (medical) ,Risk factor ,business ,Cohort study ,media_common - Abstract
What is already known about this subject • Previous studies have pointed out the question of effective training and information for health professionals on adverse drug reactions (ADRs). • This lack of training is known to induce inadequate use of drugs and noncompliance of patients. What this study adds • Our study was the first to evaluate the perceived risk of ADRs among young medical students and to investigate the impact of university pharmacology courses on their perception of this risk. • The aim of our study was not to assess a definite level of perception of risk for the different drug classes but to determine whether the perceived risk of ADRs differs after attending pharmacology courses. • Our results show that the pharmacological training allows young medical students to be aware of potentially serious ADRs, especially related to drugs considered as relatively safe, such as NSAIDs and aspirin. Aims To investigate how adverse drug reactions (ADRs) to several classes of drugs are perceived by young medical students before and after a 1 year pharmacology course. Methods The whole cohort of 92 medical students (63 females and 29 males) was questioned during their third year. A visual analogue scale was used to define a score (ranging from 0 to 10) of perceived risk of ADRs associated with each drug class before and at the end of the pharmacological training period. Results Before the pharmacology course, hypnotics were ranked as the most dangerous drugs by the medical students, followed by antidepressants and anticoagulants. Contraceptive pills were listed in the last position. After pharmacological training, antidepressants moved into the first position, followed by anticoagulants and hypnotics. When all different drug classes were taken as a whole, the mean (±SD) of median scores of the perceived risk were 4.8 (±1.3) before and 5.8 (±1.5) at the end of the pharmacology course (P
- Published
- 2007
49. Adverse drug reactions to self-medication: a study in a pharmacovigilance database
- Author
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François Montastruc, Jean-Louis Montastruc, Vanessa Rousseau, Haleh Bagheri, Delphine Abadie, Leila Chebane, Aurélia Berreni, Geneviève Durrieu, Emmanuelle Bondon-Guitton, and Jean-Paul Giroud
- Subjects
Drug ,Adult ,Male ,medicine.medical_specialty ,Otc drugs ,Time Factors ,Adolescent ,Databases, Factual ,Drug-Related Side Effects and Adverse Reactions ,media_common.quotation_subject ,Alternative medicine ,Nonprescription Drugs ,Detailed data ,Self Medication ,Severity of Illness Index ,Pharmacovigilance ,Young Adult ,Medical advice ,Risk Factors ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,Drug reaction ,Child ,Prescription Drug Misuse ,media_common ,Aged ,Pharmacology ,Aged, 80 and over ,business.industry ,Infant ,Middle Aged ,Anesthesia ,Child, Preschool ,Emergency medicine ,Female ,France ,business ,Self-medication - Abstract
Although self-medication is widely developed, there are few detailed data about its adverse drug reactions (ADRs). This study investigated the main characteristics of ADRs with self-medication recorded in the Midi-Pyrenees PharmacoVigilance between 2008 and 2014. Self-medication included first OTC drugs and second formerly prescribed drugs later used without medical advice (reuse of previously prescribed drugs). Among the 12 365 notifications recorded, 160 (1.3%) were related to SM with 186 drugs. Around three-forth of the ADRs were 'serious'. Mean age was 48.8 years with 56.3% females. The most frequent ADRs were gastrointestinal and neuropsychiatric and main drug classes involved NSAIDs, analgesics, and benzodiazepines. Phytotherapy-homeopathy accounted for 9.1% of drugs.
- Published
- 2015
50. Addendum to: Online Reporting of Adverse Drug Reactions: A Study from a French Regional Pharmacovigilance Center
- Author
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Geneviève Durrieu, Max Bert, Leyla Chebane, Delphine Abadie, and Jean-Louis Montastruc
- Subjects
medicine.medical_specialty ,business.industry ,Pharmacovigilance ,Alternative medicine ,medicine ,Addendum ,Pharmacology (medical) ,Center (algebra and category theory) ,Drug reaction ,Medical emergency ,business ,medicine.disease - Published
- 2015
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