Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Pregnancy
There are no adequate data from the use of Milnacipran in pregnant women.
Animal studies have shown reproductive toxicity (see section 5.3). Neonatal risk after pregnancy exposure with serotonin re-uptake inhibitors have been reported and may be related to either withdrawal syndrome or serotonin toxicity: tachypnea, feeding difficulties, tremors, hypertonicity or hypotonia, sleeping disorders, hyperexcitability or more rarely long- lasting crying. All these signs appear in the first days of life and are generally of short duration and not severe.

Consequently, as a precautionary measure, it is preferable to avoid Milnacipran during pregnancy and in women of childbearing potential not using contraception.

Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage following SSRI/SNRI exposure within the month prior to birth (see sections 4.4, 4.8).

Breast-feeding

Because small amounts of Milnacipran are excreted in breast-milk, breast-feeding is contraindicated.

Fertility
Milnacipran affected fertility in rats and induced embryolethality with no safety margin (see section 5.3).
No human data on the effect of active substance Milnacipran on fertility are available.