Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and Breast-feeding
Fertility
There are no human data on the potential effects of labetalol on fertility. Non-clinical data is considered insufficient.


Pregnancy
Based on experience during human pregnancy, labetalol is not expected to increase the risk of congenital malformations. Animal studies do not indicate teratogenicity. However toxicity on embryo-foetal development has been noted (see section 5.3). Due to the pharmacological action of alpha- and beta-adrenoceptor blockade, adverse effects on the foetus and neonate when used in the later stages of pregnancy (bradycardia, hypotension, respiratory depression, hypoglycaemia), should be borne in mind, as labetalol crosses the placental barrier. Close monitoring 24 - 48 hours after birth is required. Beta-blockers may reduce uterine blood flow.

Labetalol should only be used during pregnancy if the benefits for the mother outweigh the risks for the foetus.

Breast-feeding:
Labetalol is excreted in breast milk in small amounts (approximately 0.004- 0.07% of the maternal dose). Caution should be exercised when labetalol is administered to breast feeding women.
Nipple pain and Raynaud's phenomenon of the nipple have been reported (see section 4.8).