Lovastatin Pregnancy and Breastfeeding Warnings
Lovastatin Pregnancy Warnings
Lovastatin 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. The VATER association has been reported in one infant exposed to lovastatin and dextroamphetamine during organogenesis. Lovastatin 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 daily 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.
Lovastatin Breastfeeding Warnings
There are no data on the excretion of lovastatin into human milk. The manufacturer considers lovastatin to be contraindicated during lactation.
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