Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Pregnancy
There are no adequate data on the use of Asacol in pregnant women.
However, data on a limited number of exposed pregnancies indicate no adverse effect of mesalazine on pregnancy or on the foetus/newborn child. To date, no other relevant epidemiologic data are available.
In one single case after long-term use of a high dose of mesalazine (2-4 g, orally) during pregnancy, renal failure in a neonate was reported.
Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. Asacol should only be used during pregnancy if the potential benefit outweighs the possible risk.
Breastfeeding
N-acetyl-5-aminosalicylic acid and to a lesser degree mesalazine are excreted in breast milk. The clinical significance of this has not been determined. Only limited experience during lactation in women is available to date.
Hypersensitivity reactions such as diarrhoea in the infant cannot be excluded.
Therefore, Asacol should only be used during breast-feeding if the potential benefit outweighs the possible risk. If the infant develops diarrhoea, breast- feeding should be discontinued.
Fertility
No effects on fertility have been observed.