Fingolimod-associated amenorrhea: a report of three cases

Mult Scler. 2014 Oct;20(12):1662-4. doi: 10.1177/1352458514523497. Epub 2014 Feb 10.

Abstract

Amenorrhea has not been reported as an adverse event in fingolimod phase III clinical trials in patients with multiple sclerosis (MS) with either 0.5 mg or 1.25 mg dosages. Here we report three cases of young women with MS who developed amenorrhea within 6 months of initiation of fingolimod. They experienced irregularities in their menstrual cycles in the first 3 months, which progressed to amenorrhea by 5(th) or 6(th) month. Gynecology evaluations showed no other etiologies. Menses returned to baseline after discontinuation of fingolimod for 2-3 months. Amenorrhea could be associated with fingolimod in the first year. Future surveillance is advised to determine the incidence rate of this adverse event.

Keywords: Relapsing/remitting; amenorrhea; disease-modifying therapies; fingolimod.

Publication types

  • Case Reports

MeSH terms

  • Adult
  • Amenorrhea / chemically induced*
  • Amenorrhea / diagnosis
  • Female
  • Fingolimod Hydrochloride
  • Humans
  • Immunosuppressive Agents / adverse effects*
  • Immunosuppressive Agents / therapeutic use
  • Multiple Sclerosis / drug therapy*
  • Propylene Glycols / administration & dosage
  • Propylene Glycols / adverse effects*
  • Propylene Glycols / therapeutic use
  • Sphingosine / administration & dosage
  • Sphingosine / adverse effects
  • Sphingosine / analogs & derivatives*
  • Sphingosine / therapeutic use
  • Time Factors
  • Treatment Outcome

Substances

  • Immunosuppressive Agents
  • Propylene Glycols
  • Fingolimod Hydrochloride
  • Sphingosine