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…
Reviewing Author
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)