Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and Breast-feeding

Fertility
There is no information on the effect of labetalol on fertility.

Pregnancy

Based on experience of pregnancy in humans, labetalol is not expected to increase the risk of birth defects. Animal studies do not indicate teratogenicity. However, toxic effects on foetal development have been noted (see section 5.3). Depending on the pharmacological mechanism of action of alpha and beta-adrenoceptor blockade, and when these are used in late pregnancy, undesirable effects to the foetus and the neonate should be taken into consideration (bradycardia, hypotension, respiratory depression, hypoglycaemia), as labetalol crosses the placenta. Beta blockers can reduce the blood flow in the uterus.
Labetalol should be only used in pregnancy when the benefits to the mother outweigh the risks for the foetus.

Breast-feeding

Labetalol is excreted in small quantities in human milk (around 0.004–0.07 % of the mother’s dose). Nipple pain and Raynaud’s phenomenon of the nipple have been reported (see section 4.8). Caution must be observed when labetalol is administered to lactating women.