Journal
THERAPEUTICS AND CLINICAL RISK MANAGEMENT
Volume 14, Issue -, Pages 1765-1788Publisher
DOVE MEDICAL PRESS LTD
DOI: 10.2147/TCRM.S174864
Keywords
pharmacovigilance; relapsing-remitting multiple sclerosis; adverse drug reaction; disease-modifying therapy; safety
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Funding
- Italian Drug Agency (AIFA)
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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 o f monitoring the safety profile o f multiple sclerosis therapies, with particular attention to oral agents that have been introduced later in the clinical practice.
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