Clinical Correspondence
Persistent Headache in Patients With Multiple Sclerosis
Starting Treatment With Fingolimod
Yara Dadalti Fragoso, MD, MSc, PhD; Tarso Adoni, MD, PhD; Sidney Gomes, MD, PhD;
Marcus Vinicius Magno Goncalves, MD; Andre Palma da Cunha Matta, MD, PhD;
Maria Fernanda Mendes, MD, PhD; Fabio Siquineli, MD
It is difficult to think of a medication that does
not have “headache” as a potential adverse event
listed by the manufacturer. However, this symptom
is not described in detail by the pharmaceutical
companies, and no considerations are made regarding
the acceptable duration of this side effect or how
to manage it, should it occur. This letter concerns
12 potential cases of headache associated with use
of fingolimod, a new and very efficient drug for
treating multiple sclerosis (MS). Upon starting with
fingolimod, these patients presented persistent head-
ache that resembled new daily persistent headache
(NDPH) but were, in fact, attributable to a new
substance.
1
Fingolimod is an orally bioavailable compound
that antagonizes the sphingosine 1-phosphate (SP1)
receptor. In vivo, fingolimod is phosphorylated to
fingolimod-phosphate, which resembles naturally
occurring S1P. Through binding to SP1 sites in lym-
phocytes, fingolimod prevents these cells from leaving
the lymph nodes.
2
The first dose of fingolimod may be
associated with bradycardia, fatigue, gastrointestinal
disturbance, headache, and upper respiratory tract
infection.
3
Other adverse events in patients using
fingolimod that are more serious but rare include
atrioventricular block, herpetic viral infections, and
macular edema.
3
Although headache is described as a
potential side effect of fingolimod and many other
drugs for the treatment of MS, the present cases
caught our attention because of the characteristics
that these patients presented.
These patients comprised 8 males and 3 females,
of mean age 33.5 years (range 23 to 46 years), who are
undergoing treatment for MS. Fingolimod was
prescribed due to suboptimal response to other drugs.
One patient had a previous history of episodic
migraine. They were not using any drugs other than
immunomodulatory treatments for MS.
In all patients, their headache started within the
first week of use of fingolimod and persisted for at
least 3 months. In all cases, the pain was bilateral,
non-pulsatile, of moderate intensity, and persistent
From the MS Reference Center, Universidade Metropolitana
de Santos, SP, Brazil (Y.D. Fragoso); MS Reference Center,
Hospital Sirio-Libanes, Sao Paulo, SP, Brazil (T. Adoni);
Department of Neurology, Hospital Beneficencia Portuguesa
de Sao Paulo, Sao Paulo, SP, Brazil (S. Gomes); MS Unit,
Centro Hospitalar Unimed, Joinville, SC, Brazil (M.V.M.
Goncalves); Department of Neurology, Hospital Universitario
Antônio Pedro, Universidade Federal Fluminense, Niterói, RJ,
Brazil (A.P.C. Matta); Department of Neurology, Medical
School, Irmandade de Misericordia da Santa Casa de Sao
Paulo, Sao Paulo, SP, Brazil (M.F. Mendes); Department of
Neurology, Universidade Regional de Blumenau, Blumenau,
SC, Brazil (F. Siquineli).
Address all correspondence to Y.D. Fragoso, Rua da
Constituicao 374, Santos, SP CEP 11015-470, Brazil.
Accepted for publication December 16, 2014.
Conflict of Interest: The authors have no conflicts of interest to
declare.
ISSN 0017-8748
doi: 10.1111/head.12526
Published by Wiley Periodicals, Inc.
Headache
© 2015 American Headache Society
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