Altocor Pregnancy Warnings
Use is contraindicated.
US FDA pregnancy category: X
Comments: Adequate methods of contraception should be encouraged.
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 in human pregnancy. However, HMG-CoA reductase inhibitors are known to inhibit biosynthetic processes necessary in fetal development.
Serum cholesterol and triglycerides increase during normal pregnancy, and are essential for fetal development. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis, they cause fetal harm when administered to a pregnant woman. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia.
US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
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