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A multicentric pharmacovigilance study: collection and analysis of adverse drug reactions in relapsing-remitting multiple sclerosis patients

Authors Gugliandolo A, Longo F, Marrosu MG, Mancardi GL, Gandoglia I, Melis M, Lo Giudice F, Bramanti P, Mazzon E

Received 21 May 2018

Accepted for publication 15 July 2018

Published 26 September 2018 Volume 2018:14 Pages 1765—1788

DOI https://doi.org/10.2147/TCRM.S174864

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Andrew Yee

Peer reviewer comments 3

Editor who approved publication: Professor Garry Walsh


Agnese Gugliandolo,1 Federica Longo,1 Maria Giovanna Marrosu,2 Giovanni Luigi Mancardi,3,4 Ilaria Gandoglia,3 Maurizio Melis,5 Fabrizio Lo Giudice,1 Placido Bramanti,1 Emanuela Mazzon1

1Department of Experimental Neurology, IRCCS Centro Neurolesi “Bonino Pulejo”, Messina, Italy; 2Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; 3Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, Genoa, Italy; 4IRCCS Azienda Ospedaliera Universitaria San Martino-IST, Genoa, Italy; 5SC Neurologia e Stroke Unit, Azienda Ospedaliera G Brotzu, Cagliari, Italy

Purpose: We performed a pharmacovigilance study of 10 drugs used in patients with relapsing-remitting multiple sclerosis (RR-MS). Our aim was to provide an overview of the safety of these drugs by the evaluation of reported expected and unexpected adverse reactions.
Patients and methods: We collected and analyzed adverse drug reactions from RR-MS patients belonging to four hospitals in three Italian regions, for a period of 24 months.
Results: We received a total of 411 adverse reactions, of which 84.18% were expected and only 15.82% were unexpected. We found no correlation between the number of reported adverse reactions and the route of administration (injectable/intravenous drugs N=224, oral drugs N=187). However, oral agents have caused a greater number of unexpected moderate-to-severe adverse reactions while, in injectable and infusion therapies, they have been evaluated as mild–moderate adverse reactions.
Conclusion: Our results underscore the importance of monitoring the safety profile of multiple sclerosis therapies, with particular attention to oral agents that have been introduced later in the clinical practice.

Keywords: pharmacovigilance, relapsing-remitting multiple sclerosis, adverse drug reaction, disease-modifying therapy, safety

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