Atorvastatin / ezetimibe Pregnancy and Breastfeeding Warnings

Brand names: Liptruzet, Lypqozet

Atorvastatin / ezetimibe Pregnancy Warnings

Use is contraindicated

AU TGA pregnancy category: D
US FDA pregnancy category: X

Comments: This drug is contraindicated in women who are or may become pregnant; if pregnancy occurs, this drug should be discontinued and the women apprised of the potential hazard to the fetus.

Serum cholesterol and triglycerides are expected to increase during normal pregnancy. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development. Animal studies have shown both atorvastatin and ezetimibe cross the placenta. In rats, atorvastatin levels in the liver were equivalent to that of maternal plasma. Teratogenicity was not seen at doses up to 300 mg/kg/day, but at lower doses decreased pup survival and developmental delay were observed. There have been reports of congenital anomalies following intrauterine exposure to statins. With ezetimibe, there was no evidence of embryolethality, but in rats, there was an increased incidence of fetal skeletal findings. There are no adequate and well-controlled studies in humans.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Atorvastatin / ezetimibe Breastfeeding Warnings

Use should be avoided

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

Comments: Due to concerns with disruption of infant lipid metabolism, the consensus is that this drug should not be used during breastfeeding.

Statins have the potential for serious adverse reactions in nursing infants. In nursing rat pups, plasma and liver atorvastatin levels were 50% and 40% of their mother's milk, respectively. Total ezetimibe (parent drug plus active metabolite) in nursing pups was up to half that in maternal plasma.

See references

Further information

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