Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are no data available on bempedoic acid in human pregnancy to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there is insufficient data with ezetimibe. This drug may cause fetal harm based on its mechanism of action.

Comments:
-This drug should be discontinued once pregnancy is recognized unless the benefits are expected to outweigh the potential risks to the fetus.
-According to some authorities, this drug is contraindicated during pregnancy; this drug should be discontinued prior to conception; women of childbearing potential should use effective contraception during treatment (UK).

Animal studies have not shown teratogenicity of bempedoic acid in rats or rabbits at exposures estimated to be 11 and 12 times the maximum recommended human dose (MRHD), respectively. Ezetimibe studies in rats and rabbits have not shown maternal toxicity or embryo-fetal teratogenic or toxicologic effects at exposures up to 10 and 150 times the MRHD, respectively. However, based on this drug's action to decrease cholesterol synthesis and other biologically active substances derived from cholesterol, this drug may cause fetal harm when administered to pregnant women. Hyperlipidemia is generally not a condition necessary to treat during pregnancy. There are no controlled data in human pregnancy.

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

This drug may cause harm to breast fed infant based on its mechanism of action. This drug decreases cholesterol synthesis and possibly the synthesis of other biologically active substance derived from cholesterol. There are no data on the effects of this drug on the breastfed infant or its effects on milk production, but due to the potential for serious adverse reactions, breastfeeding is not recommended.

Not Recommended

Excreted into human milk: Unknown (bempedoic acid); Unknown (ezetimibe)
Excreted into animal milk: Unknown (bempedoic acid); Yes (ezetimibe)

Comments:
-Breastfeeding is not recommended due to the potential for serious adverse reaction in the breastfed infant.

See references