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Pravastatin Pregnancy and Breastfeeding Warnings

Pravastatin is also known as: Pravachol

Pravastatin Pregnancy Warnings

Pravastatin has been assigned to pregnancy category X by the FDA. Animal studies using pravastatin failed to reveal evidence of teratogenicity, however, studies with other HMG-CoA reductase inhibitors revealed an increased incidence of skeletal malformations. HMG-CoA reductase inhibitors are known to inhibit biosynthetic processes necessary for fetal development. There are no controlled data in human pregnancy. Pravastatin use is considered contraindicated during pregnancy.

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 hypercholesterolemia. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they are contraindicated during pregnancy and in nursing mothers.

Pravastatin Breastfeeding Warnings

Small quantities of pravastatin are excreted into human milk. The manufacturer considers pravastatin to be contraindicated during lactation.

The excretion of pravastatin into breast milk was evaluated in 11 women following oral administration of 20 mg of pravastatin orally twice a day for a total of five doses. The maximum concentrations of pravastatin and its major metabolite in milk following the last dose averaged 3.9 ng/mL and 2.1 ng/mL, respectively.

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