Ezetimibe / rosuvastatin Pregnancy and Breastfeeding Warnings

Brand names: Roszet

Medically reviewed by Drugs.com. Last updated on Jul 5, 2024.

Ezetimibe / rosuvastatin Pregnancy Warnings

Use is not recommended

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk Summary: Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations; the data for use of ezetimibe are insufficient to determine a risk. Based on this drug's mechanism of action, fetal harm may occur when administered to pregnant patients.

Comments:
-This drug should be discontinued when pregnancy is recognized.
-Use of adequate methods of contraception should be encouraged.
-Treatment of hyperlipidemia is generally not necessary during pregnancy; 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 hyperlipidemia for most patients.
-Some authorities contraindicate use of this drug during pregnancy.

In animal studies, oral administration of rosuvastatin to pregnant rats and rabbits during organogenesis at doses equivalent to the maximum recommended human dose (MRHD) resulted in no adverse developmental effects. Oral administration of ezetimibe to pregnant rats and rabbits during organogenesis at doses 10 and 150 times, respectively, the MRHD resulted in no adverse developmental effects. A cohort study among 1152 statin-exposed pregnant women and 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy. However, cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). There are no controlled data in human pregnancy.

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 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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Ezetimibe / rosuvastatin Breastfeeding Warnings

Use is not recommended

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

Comments:
-Based on this drugs mechanism of action, there is a potential for serious adverse reactions in a breastfed infant.
-Some authorities contraindicate use of this drug during breastfeeding

Studies in rats treated with rosuvastatin showed that unchanged drug and metabolites are excreted in milk at concentrations up to 3 times greater than those in maternal plasma. Statins are generally not recommended in women who are breastfeeding because of a concern with disruption of infant lipid metabolism. Ezetimibe is best avoided during breastfeeding for similar reasons.

See references

Further information

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