Fluvastatin Pregnancy and Breastfeeding Warnings

Brand names: Lescol, Lescol XL

Medically reviewed by Drugs.com. Last updated on Sep 23, 2024.

Fluvastatin Pregnancy Warnings

Use in women who are or may become pregnant is contraindicated.

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

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-This drug should only be used in women of childbearing potential who are highly unlikely to conceive and who have been informed of the potential hazards.
-If the patient becomes pregnant while taking this drug, therapy should be immediately discontinued, and the patient should be apprised of the potential hazard to the fetus.
-Use of adequate methods of contraception should be encouraged.

Animal studies have failed to reveal evidence of teratogenicity or embryotoxicity. However, maternal toxicity was reported at high dose levels. 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 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

Fluvastatin Breastfeeding Warnings

Use is contraindicated.

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

Based on animal data, the breast milk to plasma ratio of this drug is 2:1. Perinatal/postnatal studies in rats demonstrated mortality associated with an increase in sensitivity to cardiotoxic effects of this drug at higher doses. This drug should not be used during breastfeeding due to the potential for serious adverse events in nursing infants and the concern over disruption of infant lipid metabolism.

See references

Further information

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