Table 3.
EMA and FDA recommendations for the management of oral drugs in pregnancy and breastfeeding.
| Treatment | EMA | FDA | Milk secretion | Clinical practice |
|---|---|---|---|---|
| Dimethyl fumarate |
Pregnancy: not recommended during pregnancy and in fertile women not using appropriate contraception. Should be used only if clearly needed and if the potential benefit justifies the potential risk to the fetus. Breastfeeding: decide on the balance between infant breastfeeding versus maternal therapy. |
Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus. Breastfeeding: consider benefits of breastfeeding against possible risks to the fetus. |
Not known. | Discontinue before conception and maintain effective contraception for an appropriate time before pregnancy. Monitor disease activity with MRI, cease breastfeeding if applicable and resume therapy. |
| Fingolimod |
Pregnancy: women should not become pregnant and active contraception is recommended. Since it takes approximately 2 months to eliminate fingolimod from the body, contraception should be continued for 2 months after drug cessation before looking for pregnancy. Breastfeeding: contraindicated. |
Pregnancy: Use effective contraception during treatment and for 2 months after interruption. Use only if the potential benefit justifies the potential risk to the fetus. Breastfeeding: consider benefits of breastfeeding against possible risks to the fetus. |
Yes, in animals. | Discontinue before conception and maintain effective contraception for an appropriate period of time. Monitor disease activity with MRI, cease breastfeeding if applicable and resume therapy. |
| Siponimod |
Pregnancy: contraindicated during pregnancy. Fertile women must have a negative pregnancy test, and they should use effective contraception during treatment and for at least 10 days after discontinuation. Breastfeeding: contraindicated. |
Pregnancy: contraindicated; women should not become pregnant for at least 10 days after drug cessation. Breastfeeding: consider benefits of breastfeeding against possible risks to the fetus. |
Yes, in animals. | Discontinue therapy at least 10 days before conception while maintaining effective contraception. Breastfeeding is contraindicated. |
| Teriflunomide |
Pregnancy: contraindicated. Use accelerated drug elimination procedure if planning pregnancy or pregnancy occurs on treatment. Breastfeeding: contraindicated. |
Pregnancy: contraindicated: use accelerated drug elimination procedure if planning pregnancy or pregnancy occurs on treatment. Breastfeeding: women should not breastfeed while on treatment. |
Yes, in animals. | Use effective contraception during treatment and after treatment as long as drug plasma concentration is above 0.02 mg/l. Breastfeeding is contraindicated. |
| Cladribine |
Pregnancy: contraindicated. Women should not become pregnant for at least 6 months after the last dose. Breastfeeding: contraindicated. Women should not breastfeed for at least 1 week after the last dose. |
Pregnancy: contraindicated. Women should not become pregnant for at least 6 months after the last dose. Breastfeeding: contraindicated. Women should not breastfeed for at least 10 days after the last dose. |
Not known. | Women should not become pregnant for at least 6 months after the last dose. Women who become pregnant under therapy should discontinue treatment. Breastfeeding is contraindicated. |
EMA, European Medicines Agency; FDA, U.S. Food and Drug Administration.