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Therapies
Sous presse. Epreuves corrigées par l'auteur. Disponible en ligne depuis le jeudi 27 février 2020
Doi : 10.1016/j.therap.2020.02.012
Received : 16 September 2019 ;  accepted : 15 November 2019
Pharmacovigilance and drug-induced rare diseases: Strengths of the French Network of Regional Pharmacovigilance Centres
 

Clémence Lacroix a, Michel Mallaret b, Annie-Pierre Jonville-Bera c,
a Service de pharmacologie clinique et pharmacovigilance, centre régional de pharmacovigilance et d’information sur le médicament, Aix Marseille Université, AP–HM Marseille, 13274 Marseille, France 
b Centre régional de pharmacovigilance et d’information sur le médicament, CHU de Grenoble, 38043 Grenoble, France 
c Centre régional de pharmacovigilance et d’information sur le médicament, service de pharmacosurveillance, CHU de Tours, 37044 Tours, France 

Corresponding author. Centre régional de pharmacovigilance et d’information sur le médicament, service de pharmacosurveillance, CHU de Tours, 2, boulevard Tonnellé, 37044 Tours cedex 9, FranceCentre régional de pharmacovigilance et d’information sur le médicament, service de pharmacosurveillance, CHU de Tours2, boulevard TonnelléTours cedex 937044France
Summary

The French-style organization in the field of rare diseases allows a close contact between reference centres and regional pharmacovigilance centres thanks to their implementation within the French university hospital. This collaboration leads to highlight more and more drug-induced rare diseases. Through several historical examples (eosinophilia-myalgia syndrome due to L-tryptophan, type 1 narcolepsy with H1N1 pandemic influenza vaccine, capillary leak syndrome, acquired von Willebrand syndrome), it remains clear that pharmacovigilance is the cornerstone of the alert system. Clinicians from the rare disease reference centres can easily report adverse drug reactions (ADRs) to pharmacologists from their regional pharmacovigilance centre. Through experience, collaboration between countries, large database, and sometimes pharmacoepidemiological studies, an alert can then be raised. This collaboration underlines also similarities between the two disciplines, through the frequency of ADRs and diseases, the difficulty of the diagnosis in front of scarce data, and through the unusual worsening symptoms. Patients and associations of patients play also a proactive role as research partners at different steps, to quantify and qualify symptoms and ADRs, and also to develop orphan drugs. These several collaborations are a precious tool to improve patients’ outcomes. These close contacts between the different actors are important to make earlier diagnosis of rare diseases and severe ADRs. Rare disease does not have to mean overlooked diseases.

The full text of this article is available in PDF format.

Keywords : Pharmacovigilance, Rare disease, Adverse drug reactions, Drug-induced disease, Collaboration, Network




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