Pregnancy
Safinamide should not be used in pregnant women or women who may possibly be pregnant.
In animal studies, administration of this drug during an organogenetic period in pregnant rats induced ectopic testis, urologic changes (ureteric dilatation and renal pelvis dilatation), and skeletal abnormality in fetuses. In addition, co-administration with levodopa/carbidopa resulted in an increase in the incidence of skeletal malformation (bowing of scapula and shortening/bowing/thickening of long bones). In rabbits, coadministration with levodopa/carbidopa resulted in an increase in the incidence of cardiovascular malformation (ventricular septal defect and dilation of 1 blood vessel leading directly to the heart), which was observed with levodopa/carbidopa alone, as well as an increase in the rate of embryonic or fetal death. A study in which mothers (rats) were administered this drug pre- and post-natally showed an increased mortality and changes associated with hepatobiliary disorder (yellow/orange discoloration of the skin and skull bone) in offspring.
Lactation
Breastfeeding should be discontinued during treatment with this drug.
In animals (rats), administration of safinamide to breastfeeding mothers was associated with vacuoles in the hepatocyte and reduced glycogen in breastfed offspring. In addition, safinamide was detected in the plasma of breastfed offspring, suggesting excretion of safinamide in milk.
