There are no data regarding the use of niacin in animal reproductive studies or controlled human pregnancy studies. While animal studies with simvastatin failed to reveal evidence of teratogenicity, animal studies with other HMG-CoA reductase inhibitors revealed an increase in the incidence of skeletal malformations. There are no controlled data on the use of simvastatin in human pregnancy. However, HMG-CoA reductase inhibitors are known to inhibit biosynthetic processes necessary in fetal development. Niacin-simvastatin may cause fetal harm when administered to a pregnant woman. Niacin-simvastatin is considered contraindicated for use during pregnancy.

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Nicotinic acid is excreted into human milk, but it is not known whether simvastatin is excreted into human milk. Small amounts of a similar HMG-CoA reductase inhibitor does pass into breast milk. Because of the potential for serious adverse reactions in nursing infants, women receiving niacin-simvastatin treatment should not breastfeed their infants.

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