Priacin Use In Pregnancy & Lactation

Use in pregnancy: Safety in pregnant women has not been established. No controlled clinical trials with simvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. However, in an analysis of approximately 200 prospectively followed pregnancies exposed during the 1st trimester to Priacin or another closely related HMG-CoA reductase inhibitor, the incidence of congenital anomalies was comparable to that seen in the general population. This number of pregnancies was statistically sufficient to exclude a ≥2.5-fold increase in congenital anomalies over the background incidence. Although there is no evidence that the incidence of congenital anomalies in offspring of patients taking Priacin or another closely related HMG-CoA reductase inhibitor differs from that observed in the general population, maternal treatment with Priacin may reduce the foetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atherosclerosis is a chronic process and ordinarily discontinuation of lipid-lowering medicinal products during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolaemia. For these reasons, Priacin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with Priacin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant.
Use in lactation: It is not known whether simvastatin or its metabolites are excreted in human milk. Because many medicinal products are excreted in human milk and because of the potential for serious adverse reactions, women taking Priacin should not breastfeed their infants.