Pregnancy & Lactation : הריון/הנקה

4.6.     Fertility, pregnancy and lactation

Pregnancy

Risk related to epilepsy and antiepileptic medicinal products in general 
In the offspring of women treated with antiepileptic medication, the prevalence of malformations is two to three times greater than in the general population. Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects. Polytherapy may be associated with a higher risk of congenital malformations than monotherapy, therefore it is important that monotherapy is practiced whenever possible.

Specialist advice should be provided to all patients who could begin a pregnancy or who are in the fertile age.
The need of antiepileptic treatment must be re-evaluated when a patient plans a pregnancy.

If a patient becomes pregnant, effective antiepileptic therapy should not be suddenly interrupted, since the aggravation of the illness may be detrimental to both the mother and the foetus.

Risk related to vigabatrin

Based on data on pregnancies exposed to vigabatrin, available from spontaneous reports, abnormal outcomes (congenital anomalies or spontaneous abortion) were reported in the offspring of mothers taking vigabatrin.
No definite conclusion can be drawn as to whether vigabatrin produces an increased risk of malformation when taken during pregnancy because of limited data and the presence of concomitant antiepileptics.
Studies in animals have shown reproductive toxicity (see section 5.3).

Sabrilan should not be used during pregnancy unless the clinical condition of the woman requires treatment with vigabatrin.

There is limited amount of information on the possible occurrence of visual field defect in children who have been exposed to vigabatrin in utero.

Breast-feeding
Vigabatrin is excreted into human milk. There is insufficient information on the effects of vigabatrin in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Sabrilan therapy taking into account the benefit to breast-feeding for the child and the benefit therapy for the woman.

Fertility
Fertility studies in rats have shown no effect on male and female fertility (see section 5.3).