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Updated: May 12, 2026

Determining Immune System Suppression versus CNS Protection for Pharmacological Interventions in Autoimmune Demyelination
Published on: September 12, 2016
Natalizumab adverse events are rare in patients with multiple sclerosis
Yára Dadalti Fragoso1, Soniza Vieira Alves-Leon, Walter Oleschko Arruda
1Universidade Metropolitana de Santos (UNIMES), Santos SP, Brazil. yara@bsnet.com.br
Objective:
To assess the prevalence and the profile of adverse events (AE) of natalizumab in patients with multiple sclerosis (MS).
Methods:
Data collection from neurologists attending to patients with MS at specialized units in Brazil.
Results:
Data from 103 patients attending the infusion centers of 16 MS units in 9 Brazilian states were included in the study. The total number of infusions was 1,042. Seventy-nine patients (76.7%) did not present any AE. Twenty-four patients (23.3%) presented only mild AE. There were three major AE, including two deaths. These three occurrences, although not necessarily being drug-related, must be taken into consideration.
Conclusion:
The profile of AEs for natalizumab shows that 97% of patients have none or only mild AE. However, still due to safety worries, the use of this medication should be restricted to MS units under the care of specialized neurologists.
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