Risk Factor: CM
Class: Antilipemic agents
Fetal Risk Summary
No reports linking the use of clofibrate with congenital defects have been located. Animal reproduction studies have not been conducted with clofibrate (1).
There is pharmacologic evidence that clofibrate crosses the rat placenta and reaches measurable levels, but data in humans are lacking (2). The low molecular weight (about 243), however, indicates that the drug probably crosses the human placenta to the fetus. The drug is metabolized by glucuronide conjugation. Because this system is immature in the newborn, accumulation may occur. Consequently, the use of clofibrate near term is not recommended.
Breast Feeding Summary
No reports describing the use of clofibrate during human lactation have been located. Animal studies suggest that the drug is excreted into milk (2). The low molecular weight (about 243), also suggests that the drug is excreted into human milk. Moreover, the manufacturer states that an active metabolite has been measured in breast milk (1). Because of the potential for severe adverse effects in a nursing infant, the use of clofibrate should be considered contraindicated during breast feeding (1).
- Product information. Atromid-S. Wyeth-Ayerst Pharmaceuticals, 2000.
- Chabra S, Kurup CKR. Maternal transport of chlorophenoxyisobutyrate at the foetal and neonatal stages of development. Biochem Pharmacol 1978;27:20635.