Agomelatine Teva Use In Pregnancy & Lactation

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. As a precautionary measure, it is preferable to avoid the use of Agomelatine Teva Tablets 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. A risk to the newborns/infants cannot be excluded. A decision must be made whether or discontinue breast-feeding or to discontinue/abstain from Agomelatine Teva Tablets 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.