Women with MS Taking Fingolimod Should Be Counseled About Family Planning

Robert T. Naismith, MD

Registry data suggest a potential increased risk for teratogenicity with fingolimod treatment for multiple sclerosis.

Multiple sclerosis (MS) largely affects women of childbearing potential, and family-planning considerations are an important element of MS care. The manufacturers of fingolimod have now analyzed their data on pregnancy that occurred during clinical trials (despite requirements for contraception use in the trials), as preclinical studies in rodents suggested teratogenicity potential.

Sixty-six pregnancies occurred with exposure to fingolimod. Outcomes were 24 elective abortions, 9 spontaneous abortions, 4 abortions due to identified abnormality, and 28 live births including 26 healthy deliveries and 2 live births with congenital abnormalities. One patient was lost to follow-up. The identified abnormalities prompting elective abortion included one case each of tetralogy of Fallot, ectopic implantation, intrauterine death, and fetus stopped in evolution. The two live births with congenital abnormalities included one with acrania who died and another with posteromedial bowing of the tibia.

Citation(s):

Karlsson G et al. Pregnancy outcomes in the clinical development program of fingolimod in multiple sclerosis. Neurology 2014 Jan 24; [e-pub ahead of print].