Amlodipine / atorvastatin Pregnancy and Breastfeeding Warnings

Brand names: Caduet

Medically reviewed by Drugs.com. Last updated on Sep 21, 2023.

Amlodipine / atorvastatin Pregnancy Warnings

Use is contraindicated

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

Risk Summary: Atorvastatin is contraindicated in pregnancy since there is no apparent benefit of lipid lowering drugs during pregnancy and there is a possibility of fetal harm; limited data on both atorvastatin and amlodipine are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to mother and fetus associated with poorly controlled blood pressure during pregnancy.

Comments:
-Females of reproductive age should use effective contraception during therapy.
-Pregnant women with hypertension need to be closely monitored and managed during pregnancy.

Animal studies with amlodipine have revealed evidence of decreased litter size, increased intrauterine deaths, and prolonged gestation and labor in rats. Rats given atorvastatin at 6 times or more the maximum recommended human dose, experienced decreased postnatal growth and development. In humans, the safety of using statins (HMG-CoA reductase inhibitors) during pregnancy has not been established. These drugs decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, and therefore may cause fetal harm. Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension need to be closely monitored and managed. 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 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

Amlodipine / atorvastatin Breastfeeding Warnings

Use is contraindicated.

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

Comments:
-This drug should not be used during breastfeeding due to the potential for serious adverse events in nursing infants.

It is unknown if atorvastatin is present in human milk, but another drug in this class has been shown to be present in human milk. Atorvastatin is present in rat milk.

See references

Further information

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