Pregnancy Warnings

Pravastatin Pregnancy and Breast Feeding Warnings

Pravastatin is also known as: Pravachol

Overview

Do not use Pravastatin if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Pravastatin is found in breast milk. Do not breast-feed while you are taking Pravastatin .

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.

Pravastatin Lactation 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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