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Clinical Drug Investigation

, Volume 39, Issue 9, pp 909–913 | Cite as

Severe Exacerbation of Multiple Sclerosis Following Withdrawal of Fingolimod

  • Yara D. FragosoEmail author
  • Tarso Adoni
  • Sidney Gomes
  • Marcus V. M. Goncalves
  • Laura F. Parolin
  • Gleysson Rosa
  • Heloisa H. Ruocco
Short Communication

Abstract

Background

Fingolimod is an effective therapy for multiple sclerosis (MS). Isolated reports of very aggressive MS rebound after discontinuation of fingolimod are drawing neurologists’ attention to this potentially severe complication of the drug.

Objective

Our objective was to collect literature data on cases of MS rebound following fingolimod withdrawal. In addition, we report six new cases of this adverse event in Brazil.

Methods

We carried out a systematic review of published data on cases of MS rebound after fingolimod was discontinued. In addition, the study reports a retrospective data series of Brazilian patients presenting this rebound reaction.

Results

Twenty papers have been published reporting on 52 patients with severe MS rebound after fingolimod withdrawal. Six new patients are included in the present paper, all of them with aggressive rebound and accumulated disability sequelae.

Conclusion

We recommend gradual discontinuation of fingolimod with replacement by other treatment. The washout period should not exceed 4 weeks.

Notes

Compliance with Ethical Standards

Funding

This study received no public or private funding.

Conflict of interest

Yara D. Fragoso, Tarso Adoni, Sidney Gomes, Marcus V. M. Goncalves, Laura F. Parolin, Gleysson Rosa, and Heloisa H. Ruocco have no conflicts of interest to declare.

Ethical approval

All procedures in this study were in accordance with the 1964 Helsinki Declaration (and its amendments), with the approval of the Ethics Committee at Universidade Metropolitana de Santos, Santos, SP, Brazil. Patients have given written consent for publication of their clinical data and magnetic resonance images.

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Universidade Metropolitana de SantosSantosBrazil
  2. 2.MS and Headache ResearchSantosBrazil
  3. 3.Hospital Sirio-Libanes de Sao PauloSao PauloBrazil
  4. 4.Hospital Beneficencia Portuguesa de Sao PauloSao PauloBrazil
  5. 5.Universidade da Regiao de JoinvilleJoinvilleBrazil
  6. 6.Metrowest Medical CenterFraminghamUSA
  7. 7.Universidade Federal FluminenseNiteroiBrazil
  8. 8.Universidade Metropolitana de Santos (UNIMES)SantosBrazil

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