ArticlePharmaceuticals (Basel, Switzerland)2020
Preliminary Results of the FASM Study, an On-Going Italian Active Pharmacovigilance Project.
Article in Pharmaceuticals (Basel, Switzerland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Disease-modifying therapies and hematological disorders: a systematic review of case reports and case series.Frontiers in neurology · 2024Pooled it
- Intracerebral haemorrhage in multiple sclerosis: assessing the impact of disease-modifying medications.European journal of medical research · 2024Review
- Comparison of injective related reactions following ofatumumab and ocrelizumab in patients with multiple sclerosis: data from the European spontaneous reporting system.Frontiers in neurology · 2024Article
- The Safety Profile of COVID-19 Vaccines in Patients Diagnosed with Multiple Sclerosis: A Retrospective Observational Study.Journal of clinical medicine · 2022Article
- Severe Multiple Sclerosis Relapse After COVID-19 Vaccination: A Case Report.Frontiers in neurology · 2021Article
Corrections and comments
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Authors and funding
17 authors.
Funding
Abstract
BACKGROUND AND
aimDisease-modifying therapies (DMTs) used in multiple sclerosis (MS) have distinct safety profiles. In this paper, we report preliminary results of an on-going pharmacovigilance project (the FASM study).
resultsNeurologists working at involved multiple sclerosis centers collected 272 Individual Case Safety Reports (ICSRs). Adverse drug reactions (ADRs) mainly occurred in adult patients and in a higher percentage of women compared to men. No difference was found in ADRs distribution by seriousness. The outcome was reported as favorable in 61% of ICSRs. Out of 272 ICSRs, almost 53% reported dimethyl fumarate, fingolimod and IFN beta 1a as suspected. These medications were commonly associated to the occurrence of ADRs related hematological, gastrointestinal, general, infective or cancer disorders. The median time to event (days) was 177 for dimethyl fumarate, 1058 for fingolimod and 413 for IFN beta 1a. The median time to event for the remaining suspected drugs was 226.
conclusionWe believe that our results, together with those that will be presented at the end of the study, may bring new knowledge concerning the safety profile of DMTs and their proper use. This will provide the opportunity to draw new recommendations both for neurologists and patients.
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