Literature DB >> 10472690

[Pharmacovigilance in practice].

A Spreux1, B Baldin, R M Chichmanian.   

Abstract

Directed by the French Agency for the Safety of Health Products (AFSSAPS), the French pharmacovigilance system is in charge of the surveillance of drugs after they have been provided by AFSSAPS with official marketing authorizations that are in France either 'new drug approval certificates' (AMM) or 'temporary utilization authorizations' (ATU). About 3,700 pharmaceutical products are concerned which are used either for treatment (all drugs and remedies, inclusive plasma-derived blood products), prevention (vaccines, oral contraception), diagnosis (contrast products, ...), or to modify a physiologic function (general or local anesthetics). At the national level, the main actors of the system are AFSSAPS and its National Commission, the 31 Regional Centers of Pharmacovigilance, all the health professionnals, and the pharmaceutical laboratories. Health professionnals are held to notify any suspected serious or unexpected adverse effects as quickly as possible. The analysis of data collected by the national report bank permits alerts and inquiries about drug safety. Furthermore regional centers of pharmacovigilance are responsible for drug information. The French pharmacovigilance system works in cooperation with the European Agency for the Evaluation of Medicinal Products.

Mesh:

Year:  1999        PMID: 10472690     DOI: 10.1016/s1246-7820(99)80036-6

Source DB:  PubMed          Journal:  Transfus Clin Biol        ISSN: 1246-7820            Impact factor:   1.406


  9 in total

1.  Preventable and potentially preventable serious adverse reactions induced by oral protein kinase inhibitors through a database of adverse drug reaction reports.

Authors:  Adeline Egron; Pascale Olivier-Abbal; Aurore Gouraud; Samy Babai; Sandrine Combret; Jean-Louis Montastruc; Emmanuelle Bondon-Guitton
Journal:  Target Oncol       Date:  2014-07-25       Impact factor: 4.493

2.  Drug-induced yawning: a review of the French pharmacovigilance database.

Authors:  Agnès Sommet; Maryline Desplas; Maryse Lapeyre-Mestre; Jean-Louis Montastruc
Journal:  Drug Saf       Date:  2007       Impact factor: 5.606

3.  Spontaneous reporting of serious cutaneous reactions with protein kinase inhibitors.

Authors:  Emmanuelle Faye; Emmanuelle Bondon-Guitton; Pascale Olivier-Abbal; Jean-Louis Montastruc
Journal:  Eur J Clin Pharmacol       Date:  2013-06-09       Impact factor: 2.953

4.  Occurrences and Outcomes of Immune Checkpoint Inhibitors-Induced Vitiligo in Cancer Patients: A Retrospective Cohort Study.

Authors:  Samy Babai; Anne-Laure Voisin; Célia Bertin; Amandine Gouverneur; Hervé Le-Louet
Journal:  Drug Saf       Date:  2020-02       Impact factor: 5.606

5.  Drug interactions with cholinesterase inhibitors: an analysis of the French pharmacovigilance database and a comparison of two national drug formularies (Vidal, British National Formulary).

Authors:  Neda Tavassoli; Agnes Sommet; Maryse Lapeyre-Mestre; Haleh Bagheri; Jean-Louis Montrastruc
Journal:  Drug Saf       Date:  2007       Impact factor: 5.606

6.  Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs: dextropropoxyphene, tramadol and codeine (in combination with paracetamol).

Authors:  Neda Tavassoli; Maryse Lapeyre-Mestre; Agnès Sommet; Jean-Louis Montastruc
Journal:  Br J Clin Pharmacol       Date:  2009-09       Impact factor: 4.335

7.  Frequency and Nature of Adverse Drug Reactions Due to Non-Prescription Drugs in Children: A Retrospective Analysis from the French Pharmacovigilance Database.

Authors:  Geneviève Durrieu; Mathieu Maupiler; Vanessa Rousseau; Leila Chebane; François Montastruc; Emmanuelle Bondon-Guitton; Jean-Louis Montastruc
Journal:  Paediatr Drugs       Date:  2018-02       Impact factor: 3.022

8.  Cardiovascular risk profile of patients with peripheral arterial occlusive disease during nilotinib therapy.

Authors:  E Bondon-Guitton; S Combret; M C Pérault-Pochat; M Stève-Dumont; H Bagheri; F Huguet; F Despas; A Pathak; J L Montastruc
Journal:  Target Oncol       Date:  2016-08       Impact factor: 4.493

9.  Drug-drug interactions with imatinib: An observational study.

Authors:  Isabelle Récoché; Vanessa Rousseau; Robert Bourrel; Maryse Lapeyre-Mestre; Leila Chebane; Fabien Despas; Jean-Louis Montastruc; Emmanuelle Bondon-Guitton
Journal:  Medicine (Baltimore)       Date:  2016-10       Impact factor: 1.889

  9 in total

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