Clofibrate Pregnancy and Breastfeeding Warnings
Brand names: Atromid-S
Clofibrate Pregnancy Warnings
Clofibrate has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been conducted, although animal data does suggest placental transfer. There are no controlled data in human pregnancy. Clofibrate is considered contraindicated during pregnancy.
Animal data suggest that clofibrate crosses the placenta and is measurable, but similar data in humans is not available. No reports of congenital malformations are available.
The glucuronide metabolic system is responsible for metabolism of clofibrate, and because this system is immature in the newborn, the risk for accumulation is present. Therefore, the use of clofibrate at or near term is not recommended. The manufacturer considers the use of clofibrate contraindicated at any time during pregnancy.
Reliable birth control measures should be used in women of childbearing potential. Withdrawal of clofibrate several months before conception should be considered.
Clofibrate Breastfeeding Warnings
The active metabolite of clofibrate (clofibric acid) is excreted into human milk. The manufacturer considers clofibrate contraindicated during breast-feeding.
See also
References for pregnancy information
- (2001) "Product Information. Atromid-S (clofibrate)." Wyeth-Ayerst Laboratories
- Briggs GG, Freeman RK, Yaffe SJ.. (1998) "Drugs in Pregnancy and Lactation." Baltimore, MD: Williams & Wilkins
References for breastfeeding information
- Cayen MN (1985) "Disposition, metabolism and pharmacokinetics of antihyperlipidemic agents in laboratory animals and man." Pharmacol Ther, 29, p. 157-204
- (2001) "Product Information. Atromid-S (clofibrate)." Wyeth-Ayerst Laboratories
- Briggs GG, Freeman RK, Yaffe SJ.. (1998) "Drugs in Pregnancy and Lactation." Baltimore, MD: Williams & Wilkins
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
