Pregnancy

Simvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action. Discontinue simvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient

Lactation

Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with simvastatin

Warnings

"Contraindicated: Hypersensitivity to simvastatin, active liver disease or unexplained transaminase elevations, pregnancy, lactation Warnings: Strong CYP3A4 inhibitors, myopathy, rhabdomyolysis, liver enzyme abnormalities"