Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, Pregnancy and Lactation
Pregnancy

In animals (see section 5.3 Pre-clinical Safety Data), the abortifacient effect of Mifepristone precludes the proper assessment of any teratogenic effect of the molecule.

With subabortive doses, malformations were observed in rabbits, but not in rats, mice or monkeys. In clinical practice, rare cases of malformations of the extremity of lower limbs (out of them, club-foot) have been reported in case of mifepristone administered alone or associated with prostaglandins. One of the possible mechanisms might be amniotic band syndrome. However, data is too limited to determine whether the molecule is a human teratogen.

Consequently:

-   Women should be informed, that due to the risk of failure of the medical method of pregnancy termination and to the unknown risk to the foetus, the follow-up visit is mandatory (see Section 4.4 special warnings and special precautions for use).
-   Should a failure of the method be diagnosed at the follow-up visit (viable ongoing pregnancy), and should the patient still agree, pregnancy termination should be completed by another method.
-   Should the patient wish to continue with her pregnancy, a careful ultrasound monitoring of the pregnancy, with a special attention to the limbs, must be established in a specialised centre.

Breastfeeding
Mifepristone is excreted in mother’s milk in small amounts. Consequently, mifepristone use should be avoided during breastfeeding.

Fertility
Mifepristone does not affect fertility. It is possible that the woman becomes pregnant again as soon as the termination of pregnancy is completed. Therefore, it is important to inform the patient to start contraception immediately after the termination of the pregnancy is confirmed.