Pregnancy: The safety of venlafaxine in human pregnancy has not been established. Venlafaxine must be administered to pregnant women only if the expected benefits outweigh the possible risks. If venlafaxine is used until or shortly before birth, discontinuation effects in the newborn should be considered. Some neonates exposed to venlafaxine late in the third trimester have developed complications requiring tube-feeding, respiratory support or prolonged hospitalization. Such complications can arise immediately upon delivery.
When venlafaxine was administered orally to pregnant rats throughout gestation and lactation, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known. These effects occurred at 10 times the human daily dose (on a mg/kg basis) or 2.5 times (on a mg/m2 basis) the human daily dose of 375 mg of venlafaxine. The no-effect dose for rat pup mortality was 1.4 times the human dose, on a mg/kg basis, or 0.25 times the human dose, on a mg/m2 basis.
A prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy showed that women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.
Exposure to SNRIs in mid to late pregnancy may increase the risk for preeclampsia, and exposure to SNRIs near delivery may increase the risk for postpartum haemorrhage.
Lactation: Venlafaxine and ODV are excreted in human milk; therefore, a decision should be made whether to breast-feed or to discontinue venlafaxine.