Use in Pregnancy: Teratogenic Effects.
Pregnancy Category C: There are no adequate data regarding the use of nepafenac (Nevanac) on human pregnancy. No significant teratogenic effects were observed in rats and rabbits orally administered with doses of nepafenac up to 2500 times greater than the maximum recommended human ocular dose. Since human systemic exposure is negligible (< 1 ng/mL) after treatment with nepafenac (Nevanac), the risk during pregnancy could be considered low. Nevertheless, inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/fetal development and/or parturition and/or postnatal development.
Nepafenac (Nevanac) is not recommended during pregnancy unless the benefit outweighs the potential risk.
Non-teratogenic Effects: Because of the known effects of prostaglandin biosynthesis inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of nepafenac (Nevanac) Sterile Ophthalmic Suspension during late pregnancy should be avoided.
Use in Lactation: Nepafenac (Nevanac) Sterile Ophthalmic Suspension is excreted in the milk of pregnant rats. It is unknown whether nepafenac is excreted in human milk after topical administration. Because many drugs excreted in human milk, caution should be exercised when nepafenac (Nevanac) Sterile Ophthalmic Suspension is administered to a nursing woman. Animal studies have shown excretion of nepafenac in the milk of rats after oral administration. While no effects on the suckling child are anticipated since the systemic exposure of the breastfeeding woman to nepafenac is negligible (<1 ng/mL), caution should be exercised when nepafenac (Nevanac) is administered to a nursing woman.