Cerivastatin Pregnancy and Breastfeeding Warnings

Brand names: Baycol

Cerivastatin Pregnancy Warnings

Cerivastatin has been assigned to pregnancy category X by the FDA. Animal studies have revealed evidence of teratogenicity, including 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. Rare cases of congenital anomalies have been reported following prenatal exposure to other HMG-CoA reductase inhibitors. Cerivastatin use is considered contraindicated during pregnancy.

The VATER association (vertebral anomalies, anal atresia, tracheo-esophageal fistula with esophageal atresia, renal and radial dysplasia) was reported in an infant girl whose mother received lovastatin 10 mg and dextroamphetamine 10 mg daily during the first trimester of pregnancy for the treatment of hypercholesterolemia and progressive weight gain. Both drugs were discontinued five weeks later, at approximately nine weeks gestation, when pregnancy was confirmed.

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Cerivastatin Breastfeeding Warnings

Cerivastatin is excreted into human milk. According to the manufacturer, the breast milk to plasma ratio of cerivastatin based on preclinical data is 1.3:1. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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Further information

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