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  1. Article ; Online: Cross-reactivity among and between macrolides, lincosamides, and streptogramins: Study on the French pharmacovigilance database.

    Le Baron, Quentin / Bourneau-Martin, Delphine / Babin, Marina / Gouraud, Aurore / Tauber, Marie / Fresse, Audrey / Lebrun-Vignes, Bénédicte / Delaunay, Juliette / Morisset, Martine / Briet, Marie

    Fundamental & clinical pharmacology

    2024  

    Abstract: Background: Hypersensitivity reactions (HSR) are reported for the macrolides, lincosamides, and streptogramins (MLS) antibiotic family. Data about cross-reactivity among and between MLS remain scarce or controversial.: Objectives: The aim of this ... ...

    Abstract Background: Hypersensitivity reactions (HSR) are reported for the macrolides, lincosamides, and streptogramins (MLS) antibiotic family. Data about cross-reactivity among and between MLS remain scarce or controversial.
    Objectives: The aim of this study was to provide an overview of hypersensitivity cross-reactions among MLSs based on data extracted from the French National Pharmacovigilance Database (FPVD).
    Methods: Cases of HSR to MLSs reported between January 1985 and December 2019 were extracted from the FPVD using standardized MedDRA queries (SMQ). Cases including an allergological test involving multiple MLSs and giving at least one positive result were included.
    Results: Of the 8394 cases reviewed, 149 were included. HSR mainly involved pristinamycin (n = 83; 53.2%) and spiramycin (n = 31; 19.9%). HSR to MLS was immediate in 54 cases and delayed in 94 cases. Skin tests represented the majority of the allergological tests performed (n = 728; 84.7%), followed by reintroduction tests (n = 79; 9.2%). Eighty-six cross-reactivities among MLS were identified in 62 cases (41.6%). All the 25 explorations performed for streptogramins showed cross-reactivities, but only 30/253 among macrolides (11.9%). Cross-reactivities between the three MLS were observed in 31/322 (9.6%) of the allergological explorations.
    Conclusion: This study highlights the possibility of cross-reactivity among and between MLSs. Dermatologists and allergologists managing patients with HSR to MLSs should be aware of a risk of cross-reactivity among the macrolides and between the different classes of MLS and to perform MLSs allergological testing before recommending an alternative antibiotic, especially in severe drug hypersensitivity from the MLS family.
    Language English
    Publishing date 2024-04-08
    Publishing country England
    Document type Journal Article
    ZDB-ID 639134-5
    ISSN 1472-8206 ; 0767-3981
    ISSN (online) 1472-8206
    ISSN 0767-3981
    DOI 10.1111/fcp.13005
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Adverse drug effect in the context of drug shortage: the CIRUPT prospective study from the French pharmacovigilance network.

    Bourneau-Martin, Delphine / Grandvuillemin, Aurelie / Babin, Marina / Mullet, Charlotte / Said, Hillary / Cellier, Morgane / Geniaux, Helene / Gautier, Sophie / Beurrier, Mathilde / Veyrac, Gwenaelle / Lagarce, Laurence / Laroche, Marie-Laure / Briet, Marie

    European journal of hospital pharmacy : science and practice

    2024  

    Abstract: Objectives: Drug shortages are of increasing concern to worldwide public health. The consequences of drug shortages for patient safety have been little studied, especially from a pharmacovigilance point of view. In this context, the network of French ... ...

    Abstract Objectives: Drug shortages are of increasing concern to worldwide public health. The consequences of drug shortages for patient safety have been little studied, especially from a pharmacovigilance point of view. In this context, the network of French pharmacovigilance centres conducted the CIRUPT study (Conséquences Iatrogènes des RUPTures de stock/iatrogenic consequences of drug shortages) based on a prospective campaign of adverse effects occurring in the context of drug shortage notifications.
    Methods: All notifications involving a shortage drug submitted to the French pharmacovigilance centres between 1 January 2020 and 30 June 2021 were collected and registered in the French national pharmacovigilance database with the standardised high level term 'product supply and availability issues' and with predefined keywords in the narrative section.
    Results: 224 cases were included, involving mainly adverse drug reactions (ADRs) (n=131/224, 59%) and medication errors (n=51/224, 23%); 29% of the cases were serious. The most represented classes of shortage drugs were: vaccines (n=78/224, 35%); drugs for acid-related disorders (H2-receptor antagonists) (n=27/224, 12%); antineoplastic agents (n=17/224, 8%); and antiepileptics (n=15/224, 7%). In 82% of cases, the involved shortage drug was the subject of information delivered to health professionals by the National Agency for the Safety of Medicines and Health Products. Drug shortages were associated with an ADR related to replacement drugs in 59% (n=131/224) of the cases, drug inefficacy in 18% (n=41/224), and/or an aggravation of the underlying disease in 11% (n=25/224).
    Conclusions: From a pharmacovigilance point of view, a large diversity of anatomical therapeutic classes is involved and the risk related to drug shortages is not limited to drugs registered on 'major therapeutic interest or essential drug' lists. Information from health agencies is not sufficient to avoid the risks, and further strategies should be developed.
    Language English
    Publishing date 2024-04-15
    Publishing country England
    Document type Journal Article
    ZDB-ID 2650179-X
    ISSN 2047-9964 ; 2047-9956
    ISSN (online) 2047-9964
    ISSN 2047-9956
    DOI 10.1136/ejhpharm-2023-004047
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Case report: Nicolau livedoid dermatitis following an intramuscular injection of sustained release octreotide.

    Bérard, Mathilde / Babin, Marina / Bourneau-Martin, Delphine / Le Clec'h, Christian

    Therapie

    2021  Volume 77, Issue 3, Page(s) 386–388

    MeSH term(s) Delayed-Action Preparations/adverse effects ; Drug Eruptions/etiology ; Humans ; Injections, Intramuscular ; Nicolau Syndrome/etiology ; Octreotide/adverse effects
    Chemical Substances Delayed-Action Preparations ; Octreotide (RWM8CCW8GP)
    Language English
    Publishing date 2021-04-24
    Publishing country France
    Document type Case Reports ; Letter
    ZDB-ID 603474-3
    ISSN 1958-5578 ; 0040-5957
    ISSN (online) 1958-5578
    ISSN 0040-5957
    DOI 10.1016/j.therap.2021.04.009
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Drug-induced vitiligo: a case/non-case study in Vigibase

    Anthony, Norah / Bourneau-Martin, Delphine / Ghamrawi, Sarah / Lagarce, Laurence / Babin, Marina / Briet, Marie

    Fundamental & clinical pharmacology

    2020  Volume 34, Issue 6, Page(s) 736–742

    Abstract: Vitiligo is a common depigmenting disorder ensuing the loss of epidermal melanocytes. It is a multifactorial disease with immunological, genetic and environmental factors including drug exposure. The purpose of the study was to investigate the drugs and ... ...

    Abstract Vitiligo is a common depigmenting disorder ensuing the loss of epidermal melanocytes. It is a multifactorial disease with immunological, genetic and environmental factors including drug exposure. The purpose of the study was to investigate the drugs and therapeutic subclasses associated with vitiligo occurrence reported in VigiBase
    MeSH term(s) Adverse Drug Reaction Reporting Systems/statistics & numerical data ; Female ; Global Health ; Humans ; Male ; Middle Aged ; Pharmacovigilance ; Retrospective Studies ; Vitiligo/chemically induced ; Vitiligo/epidemiology ; World Health Organization
    Language English
    Publishing date 2020-04-27
    Publishing country England
    Document type Journal Article
    ZDB-ID 639134-5
    ISSN 1472-8206 ; 0767-3981
    ISSN (online) 1472-8206
    ISSN 0767-3981
    DOI 10.1111/fcp.12558
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Renal Safety Profile of EGFR Targeted Therapies: A Study from VigiBase

    Crosnier, Alexandre / Abbara, Chadi / Cellier, Morgane / Lagarce, Laurence / Babin, Marina / Bourneau-Martin, Delphine / Briet, Marie

    Cancers

    2021  Volume 13, Issue 23

    Abstract: Kidney EGFR expression together with reported cases of glomerular diseases in the context of anti-EGFR drug administration raise concerns about the renal safety profile of these drugs. This issue is addressed in a case/non-case study carried out on ... ...

    Abstract Kidney EGFR expression together with reported cases of glomerular diseases in the context of anti-EGFR drug administration raise concerns about the renal safety profile of these drugs. This issue is addressed in a case/non-case study carried out on VigiBase
    Language English
    Publishing date 2021-11-24
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2527080-1
    ISSN 2072-6694
    ISSN 2072-6694
    DOI 10.3390/cancers13235907
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: Spontaneous Reports of Serious Adverse Drug Reactions Resulting From Drug-Drug Interactions: An Analysis From the French Pharmacovigilance Database.

    Létinier, Louis / Ferreira, Amandine / Marceron, Alexandre / Babin, Marina / Micallef, Joëlle / Miremont-Salamé, Ghada / Pariente, Antoine

    Frontiers in pharmacology

    2021  Volume 11, Page(s) 624562

    Abstract: Few data are available on the clinical impact of drug-drug interactions (DDIs). Most of the studies are limited to the analysis of exposure to potential DDI or the targeted impact of the combination of a few drugs or therapeutic classes. The analysis of ... ...

    Abstract Few data are available on the clinical impact of drug-drug interactions (DDIs). Most of the studies are limited to the analysis of exposure to potential DDI or the targeted impact of the combination of a few drugs or therapeutic classes. The analysis of adverse drug reaction (ADR) reports could be a mean to study generally the adverse effects identified due to a DDI. Our objective was to describe the characteristics of ADRs resulting from DDIs reported to the French Pharmacovigilance system and to identify the drugs most often implicated in these ADRs. Considering all ADR reports from January 01, 2012, to December 31, 2016, we identified all cases of ADR resulting from a DDI (DDI-ADRs). We then described these in terms of patients' characteristics, ADR seriousness, drugs involved (two or more per case), and ADR type. Of the 4,027 reports relating to DDI-ADRs, 3,303 were related to serious ADRs. Patients with serious DDI-ADRs had a median age of 76 years (interquartile range: 63-84); 53% were male. Of all serious DDI-ADRs, 11% were life-threatening and 8% fatal. In 36% of cases, the DDI causing the ADR involved at least three drugs. Overall, 8,424 different drugs were mentioned in the 3,303 serious DDI-ADRs considered. Altogether, drugs from the "antithrombotic agents" subgroup were incriminated in 34% of serious DDI-ADRs. Antidepressants were the second most represented therapeutic/pharmacological subgroup (5% of serious DDI-ADRs). Among the 3,843 ADR types reported in the 3,303 serious DDI-ADRs considered, the most frequently represented were hemorrhage (40% clinical hemorrhage; 6% biological hemorrhage), renal failure (8%), pharmacokinetic alteration (5%), and cardiac arrhythmias (4%). Hemorrhagic accidents are still an important part of serious ADRs resulting from DDIs reported in France. The other clinical consequences of DDIs seem less well identified by pharmacovigilance. Moreover, more than one-third of serious DDI-ADRs involved at least three drugs.
    Language English
    Publishing date 2021-03-24
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2587355-6
    ISSN 1663-9812
    ISSN 1663-9812
    DOI 10.3389/fphar.2020.624562
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Drug interactions related to self-medication: a French pharmacovigilance database study.

    Vacher, Robin / Lagarce, Laurence / Ghamrawi, Sarah / Laugier-Castellan, Delphine / Vial, Thierry / Bagheri, Haleh / Babin, Marina / Briet, Marie

    Fundamental & clinical pharmacology

    2020  Volume 34, Issue 5, Page(s) 623–631

    Abstract: Self-medication (SM) is a common practice perceived by patients as harmless which can, however, entail health risks. The aim of the study was to identify drug-drug interactions (DDIs) involving SM drugs leading to adverse drug reactions (ADRs) in the ... ...

    Abstract Self-medication (SM) is a common practice perceived by patients as harmless which can, however, entail health risks. The aim of the study was to identify drug-drug interactions (DDIs) involving SM drugs leading to adverse drug reactions (ADRs) in the National French Pharmacovigilance Database. All ADR reports from 1 January 1985 to 31 July 312018, coded as 'interaction' and 'self-medication', were selected and studied. Patient characteristics, the level and type of interaction, and the therapeutic classes of the drugs were examined. Adverse drug reactions were analysed and classified according to the system organ classes of the Medical Dictionary for Regulatory Activities. One hundred and three reports totalling 158 ADRs (71% severe cases) were included; 153 DDIs (59.5% pharmacodynamic) involving 234 drugs were identified. The latter included 119 SM drugs (51% available on prescription), mainly analgaesics, anti-inflammatory drugs, dietary supplements and antibiotics. Haemostasis disorders and renal failure were the most frequently reported ADRs. The analysis of reference documents raised concerns on the lack of information provided by package leaflets. In conclusion, the present study highlights the risks of medically unapproved re-use of prescription drugs or the consumption of dietary supplements without monitoring possible interactions and ADRs. Patient awareness could be improved by more regular updates of medication package inserts.
    MeSH term(s) Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems ; Aged ; Aged, 80 and over ; Databases, Factual ; Drug Interactions ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Drug-Related Side Effects and Adverse Reactions/etiology ; Female ; France/epidemiology ; Humans ; Male ; Middle Aged ; Pharmacovigilance ; Self Medication ; Young Adult
    Language English
    Publishing date 2020-03-13
    Publishing country England
    Document type Journal Article
    ZDB-ID 639134-5
    ISSN 1472-8206 ; 0767-3981
    ISSN (online) 1472-8206
    ISSN 0767-3981
    DOI 10.1111/fcp.12546
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Adverse drug reaction related to drug shortage: A retrospective study on the French National Pharmacovigilance Database.

    Bourneau-Martin, Delphine / Babin, Marina / Grandvuillemin, Aurélie / Mullet, Charlotte / Salvo, Francesco / Singier, Allison / Cellier, Morgane / Fresse, Audrey / de Canecaude, Claire / Pietri, Tessa / Drablier, Guillaume / Geniaux, Hélène / Lagarce, Laurence / Laroche, Marie-Laure / Briet, Marie

    British journal of clinical pharmacology

    2022  Volume 89, Issue 3, Page(s) 1080–1088

    Abstract: Aim: Drug shortages are a growing global health issue. The aim of the study was to evaluate the consequences of drug shortages on patient safety based on data recorded in the French National Pharmacovigilance Database.: Methods: All cases involving ... ...

    Abstract Aim: Drug shortages are a growing global health issue. The aim of the study was to evaluate the consequences of drug shortages on patient safety based on data recorded in the French National Pharmacovigilance Database.
    Methods: All cases involving drug shortages reported from 1985 to the end of 2019 were extracted from the database.
    Results: Following the selection process, 462 cases were included. The number of cases increased significantly from 2004 to 2019. Cases mainly involved drugs from the nervous system (22.1%, 95% confidence interval [CI] 17.5-27.0%), the cardiovascular system (16.4%, 95% CI 11.9-21.4%) and anti-infectives for systemic use (14.3%, 95% CI 9.7-19.2%) ATC classes. Most of the cases reported an adverse drug reaction (ADR) belonging to the SOC nervous system (21%, 95% CI 18-24%), skin and subcutaneous (14%, 95% CI 11-17%), general (13%, 95% CI 10-17%) and gastrointestinal (8%, 95% CI 5-11%) disorders. Disease worsening was observed in 15.9% of the cases, mostly related to a lack of efficacy of the replacement drug. Half of the cases were considered as serious. Evolution was favourable in 79.4% of the cases. Death and/or life-threatening situations were reported in 5.8% of the cases. Medication errors (MEs) were identified in 51 cases (11%), mostly occurring at the administration step and involving a human factor.
    Conclusion: This study emphasizes the clinical impact of drug shortage in terms of ADRs, ME and inefficiency. These observations underline the importance of a global health policy programme to limit the occurrence of drug shortages and to reinforce the information provided to patients and health care professionals in this context to limit risk.
    MeSH term(s) Humans ; Pharmacovigilance ; Retrospective Studies ; Adverse Drug Reaction Reporting Systems ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Medication Errors ; Pharmaceutical Preparations ; Databases, Factual
    Chemical Substances Pharmaceutical Preparations
    Language English
    Publishing date 2022-10-19
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 188974-6
    ISSN 1365-2125 ; 0306-5251 ; 0264-3774
    ISSN (online) 1365-2125
    ISSN 0306-5251 ; 0264-3774
    DOI 10.1111/bcp.15550
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Delayed thrombocytopenia following administration of abciximab: Pharmacovigilance survey and literature review.

    Vincent, Louis / Bourneau-Martin, Delphine / Maurier, Anaïs / Babin, Marina / Delepine, Stéphane / Helley, Dominique / Grandvuillemin, Aurélie / Lagarce, Laurence / Lillo-Le Louët, Agnès / Briet, Marie

    Therapie

    2021  Volume 76, Issue 6, Page(s) 687–693

    Abstract: Background: Abciximab (ABX) is used for acute coronary syndrome and unstable angina. Thrombocytopenia is a frequent adverse effect described as occurring in the first 24hours. The aim of this study was to evaluate, in a context of pharmacovigilance ... ...

    Abstract Background: Abciximab (ABX) is used for acute coronary syndrome and unstable angina. Thrombocytopenia is a frequent adverse effect described as occurring in the first 24hours. The aim of this study was to evaluate, in a context of pharmacovigilance survey, the occurrence of delayed thrombocytopenia following ABX infusion in pharmacovigilance database reports and in the literature.
    Methods: Individual case safety reports (ICSRs) of delayed thrombocytopenia-between 3 and 30 days - with ABX presented as a single suspect were selected in VigiBase®, the WHO global database of ICSRs. The French cases were then extracted from the French national pharmacovigilance database. In addition, a literature review of published cases was performed using PubMed.
    Results: Among the 84 ICSRs selected from VigiBase®, 43 were also reported in the FPVD. Mean age was 60.1±12.3 years with a majority of male patients (77.4%). The average time to onset (TTO) was 8.9±5.2 days. Thrombocytopenia regressed in 5.1±2.7 days. Haemorrhagic complications were reported in 15% of ICSRs. In the French cases, the median nadir of platelet count was 28×10
    Conclusion: Delayed thrombocytopenia, probably due to immune reaction, is a possible life-threatening adverse effect of ABX with a mean TTO of 9 days, supporting the recommendation of a platelet count monitoring during at least two weeks. This recommendation was added to the abcximab SmPC in 2019.
    MeSH term(s) Abciximab ; Aged ; Antibodies, Monoclonal ; Humans ; Immunoglobulin Fab Fragments ; Male ; Middle Aged ; Pharmacovigilance ; Platelet Aggregation Inhibitors/adverse effects ; Thrombocytopenia/chemically induced ; Thrombocytopenia/epidemiology
    Chemical Substances Antibodies, Monoclonal ; Immunoglobulin Fab Fragments ; Platelet Aggregation Inhibitors ; Abciximab (X85G7936GV)
    Language English
    Publishing date 2021-02-22
    Publishing country France
    Document type Journal Article ; Review
    ZDB-ID 603474-3
    ISSN 1958-5578 ; 0040-5957
    ISSN (online) 1958-5578
    ISSN 0040-5957
    DOI 10.1016/j.therap.2021.02.006
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Liquid formulation of ifosfamide increased risk of encephalopathy: A case-control study in a pediatric population.

    Hillaire-Buys, Dominique / Mousset, Mégane / Allouchery, Marion / Azzouz, Brahim / Babin, Marina / Bellet, Florelle / Béné, Johana / Default, Anne / Durrieu, Geneviève / Géniaux, Hélène / Grandvuillemin, Aurélie / Gras-Champel, Valérie / Jantzem, Hélène / Lambert, Aude / Lepelley, Marion / Massy, Nathalie / Petitpain, Nadine / Rocher, Fanny / Sanchez-Pena, Paola /
    Sassier, Marion / Simon, Corinne / Triquet, Louise / Valnet-Rabier, Marie-Blanche / Veyrac, Gwenaëlle / Faillie, Jean-Luc / Zenut, Marie-Christine

    Therapie

    2019  Volume 75, Issue 5, Page(s) 471–480

    Abstract: 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 ...

    Abstract 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 (<18 y.o.) receiving liquid formulation or lyophilized powder formulation during the study period were included. Patients with at least one occurrence of encephalopathy were considered as cases. Logistic regression model was used to estimate the odds ratio of encephalopathy between exposure groups.
    Results: During the study period, 52 cases and 495 controls were included. A residual over-risk of encephalopathy was associated with ifosfamide 7-month shelf-life liquid formulation compared to lyophilized powder (adjusted OR 1.91, 95% CI: 1.03-3.53).
    Conclusions: Observed difference does not seem to be related to the pathology treated, the doses used, the co-medications, a meningeal localization and/or an irradiation of the central nervous system. This study confirms data from spontaneous reports that led to the precautionary measure for the liquid formulation. Even if the risk of encephalopathy seems reduced, our study suggests the persistence of a residual risk of encephalopathy associated with liquid formulation compared to the lyophilized powder.
    MeSH term(s) Antineoplastic Agents, Alkylating/adverse effects ; Brain Diseases/chemically induced ; Brain Diseases/drug therapy ; Brain Diseases/epidemiology ; Case-Control Studies ; Child ; Humans ; Ifosfamide/adverse effects ; Retrospective Studies ; Risk Factors
    Chemical Substances Antineoplastic Agents, Alkylating ; Ifosfamide (UM20QQM95Y)
    Language English
    Publishing date 2019-10-28
    Publishing country France
    Document type Journal Article ; Observational Study
    ZDB-ID 603474-3
    ISSN 1958-5578 ; 0040-5957
    ISSN (online) 1958-5578
    ISSN 0040-5957
    DOI 10.1016/j.therap.2019.08.001
    Database MEDical Literature Analysis and Retrieval System OnLINE

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