Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of agomelatine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of Valdoxan during pregnancy.
Breast-feeding: It is not known whether agomelatine/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of agomelatine/metabolites in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Valdoxan therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).