Pregnancy & Lactation : הריון/הנקה

4.6    PREGNANCY AND LACTATION
Pregnancy
Published data on a limited number of exposed pregnancies in women with diabetes insipidus (n = 53) as well as data on exposed pregnancies in women with bleeding complications (n=216) no adverse effects of desmopressin on pregnancy or on the health of the foetus/newborn child.. To date, no other relevant epidemiological data are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

Caution should be exercised when prescribing to pregnant women.

Animal reproduction studies have shown no clinically relevant effects on parents and offspring. In vitro analysis of human cotyledon models have shown that there is no transplacental transport of desmopressin when administered at therapeutic concentration corresponding to recommended dose.

Lactation
Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 μg intranasally), indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.