Corstat Use In Pregnancy & Lactation

Use in pregnancy: Corstat is contraindicated in pregnancy (see Contraindications).
Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidaemia. Moreover, cholesterol and other products of cholesterol biosynthesis pathway are essential components for foetal development during, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase eg, Corstat to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway. Corstat is contraindicated for use in pregnancy and women of child bearing potential unless such patient are highly unlikely to conceive or such patients are adequately protected by nonhormonal methods. An interval of 1 month should elapse between the end of therapy with Corstat and planned conception. If the patient becomes pregnant while taking simvastatin, Corstat should be discontinued immediately and the patient apprised of the potential hazard to the foetus.
The active metabolite of simvastatin was shown to produce foetal malformation in the offspring of pregnant rats. A few reports have been received of congenital anomalies in infants whose mothers were treated during pregnancy with HMG-CoA reductase inhibitors.
In a review of approximately 100 prospectively followed pregnancies in women exposed to Corstat or another structurally related HMG-CoA reductase inhibitor, the incidences of congenital anomalies are expected in the general population. As safety in pregnant women has not been established and there is no apparent benefit to therapy with Corstat during pregnancy, treatment should be immediately discontinued as soon as pregnancy is recognised.
Use in lactation: It is not yet known whether simvastatin or its metabolites are excreted in human milk. Corstat should be avoided during lactation.