Use in pregnancy: Pregnancy Category C: Safety in pregnant women has not been established. There are no adequate and well-controlled studies of fenofibrate in pregnant women. Fenofibrate should not be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Fenofibrate should not be used in nursing mothers.
145-mg: A decision should be made whether to discontinue nursing or to Colestrim Supra, taking into account the importance of Colestrim Supra to the mother.
160-mg: Because of the potential for tumorigenicity seen in animal studies, a decision should be made whether to discontinue nursing or to discontinue Colestrim.