Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Women of childbearing age
If diazepam is used in a female patient of childbearing age, she should be advised to contact her physician immediately if she wishes to become pregnant or if she suspects pregnancy.

Pregnancy
In pregnancy, diazepam should be used only in exceptional cases with stringent indication – neither in high doses nor over a prolonged period.

Diazepam and its main metabolite N-desmethyldiazepam cross the placenta. Diazepam accumulates in the fetal compartment and the blood of the newborn can reach concentrations that are three times those of the maternal concentration.

The malformation risk in humans after use of therapeutic doses of benzodiazepines in early pregnancy seems to be low, although a number of epidemiological studies have provided evidence of an increased risl of cleft palate.

There are case reports of malformations and intellectual disability in prenatally exposed children after benzodiazepine overdoses and intoxication.

Children of mothers who, during the pregnancy, have received benzodiazepines over a longer period can develop physical dependency. These children present withdrawal symptoms in the post-partum phase.

If, for urgent reasons, diazepam is administered in high doses in late pregnancy or during delivery, effects on the newborn baby such as respiratory failure, hypothermia, hyperactivity, excitability, hypotension, reduced muscle tone and feeding problems (floppy infant syndrome) can be expected.

Lactation
Diazepam and its metabolic products pass into breast milk. The milk-plasma ratio shows important individual differences. As diazepam is metabolized to a significantly slower 
extent in newborn babies than in children or adults, babies should not be breastfed by women under diazepam therapy. In case of an urgent indication, weaning is necessary.