Table 2.

EMA and FDA recommendations for the management of self-injectable DTMs in pregnancy and breastfeeding.

Treatment	EMA	FDA	Milk secretion	Clinical practice
Interferons beta	Pregnancy: initiation of treatment contraindicated during pregnancy. Update of EMA in 2019 allows to consider continuing IFNβ-1a until conception and during pregnancy as clinically needed. Breastfeeding: no harmful effects on breastfed infants are anticipated; can be used during breastfeeding.	Pregnancy: Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Breastfeeding: administer with caution to a nursing mother.	Not known.	Continue until pregnancy confirmed. In selected patients with highly active disease, may be administered throughout pregnancy after careful evaluation of the risk–benefit ratio.
Glatiramer acetate	Pregnancy: pregnancy contraindication removed from the EU label in 2017. Breastfeeding: decide on the balance between infant breastfeeding versus maternal therapy.	Pregnancy: Only use during pregnancy if clearly needed. Breastfeeding: consider benefits of breastfeeding against possible risks to the fetus.	Not known.	Continue until pregnancy confirmed. Continued use in pregnancy now supported in some cases.

EMA, European Medicines Agency; FDA, U.S. Food and Drug Administration.