Lovastatin Pregnancy and Breastfeeding Warnings

Brand names: Altocor, Altoprev, Mevacor

Medically reviewed by Drugs.com. Last updated on Sep 26, 2024.

Lovastatin Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category: Not assigned

Risk summary: Based on the mechanism of action, this drug may cause fetal harm when administered to a pregnant woman. Inadequate data available on the use of this drug in pregnant women to inform of a drug-related risk.

Comments: Adequate methods of contraception should be encouraged.

While animal studies with this drug 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Lovastatin Breastfeeding Warnings

Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

Further information

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