Glatiramer acetate to treat multiple sclerosis during pregnancy and lactation: a safety evaluation

Expert Opin Drug Saf. 2014 Dec;13(12):1743-8. doi: 10.1517/14740338.2014.955849. Epub 2014 Sep 1.


Introduction: Multiple sclerosis (MS) is a disease that mainly affects young adults who are of reproductive age. MS can lead to severe disability and is associated with worse prognosis in untreated patients. Although MS is not negatively affected by pregnancy itself, it may be a high-risk decision to leave a woman without treatment because she may get pregnant.

Areas covered: This paper reviews the literature on pregnancies where the mother was exposed to glatiramer acetate . Few data are available on paternal exposure, but this does not seem to pose a problem due to the pharmacological characteristics of the drug. Only a limited amount of data from individual groups in the world is available in the literature.

Expert opinion: TEVA Pharmaceuticals would need to open the database on pregnancy exposure to glatiramer acetate to allow for proper conclusions. Glatiramer acetate is a drug of low risk in pregnancy (category B in the FDA classification) and may be a safe option for the treatment of women of fertile age with MS.

Keywords: glatiramer acetate; lactation; malformations; pregnancy; safety.

Publication types

  • Review

MeSH terms

  • Animals
  • Female
  • Glatiramer Acetate
  • Humans
  • Immunosuppressive Agents / adverse effects*
  • Immunosuppressive Agents / pharmacology
  • Immunosuppressive Agents / therapeutic use*
  • Lactation / drug effects*
  • Multiple Sclerosis / drug therapy*
  • Peptides / adverse effects*
  • Peptides / pharmacology
  • Peptides / therapeutic use*
  • Pregnancy


  • Immunosuppressive Agents
  • Peptides
  • Glatiramer Acetate