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Use in Pregnancy: Risk Related to Epilepsy and Antiepileptic Medicinal Products in General: It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population. In the treated population, an increase in malformations has been noted with polytherapy; however, the extent to which the treatment and/or the illness is responsible has not been elucidated.
Moreover, effective antiepileptic therapy must not be interrupted, since the aggravation of the illness is detrimental to both the mother and the foetus.
Risk Related to Rufinamide: Studies in animals revealed no teratogenic effect but foetotoxicity in presence of maternal toxicity (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). The potential risk for humans is unknown.
For rufinamide, no clinical data on exposed pregnancies are available.
Taking these data into consideration, rufinamide should not be used during pregnancy unless clearly necessary and in women of childbearing age not using contraceptive measures.
Women of childbearing potential must use contraceptive measures during treatment with rufinamide. Physicians should try to ensure that appropriate contraception is used, and should use clinical judgment when assessing whether oral contraceptives, or the doses of the oral contraceptive components, are adequate based on the individual patients clinical situation (see Precautions).
If women treated with rufinamide plan to become pregnant, the indication of this product should be carefully weighed. During pregnancy, an effective antiepileptic rufinamide treatment must not be interrupted, since the aggravation of the illness is detrimental to both the mother and the foetus.
Use in Lactation: It is not known if rufinamide is excreted in human breast milk. Due to the potential harmful effects for the breast fed infant, breast-feeding should be avoided during maternal treatment with rufinamide.
