Fenofibrate Pregnancy and Breastfeeding Warnings
Fenofibrate Pregnancy Warnings
Fenofibrate has been assigned to pregnancy category C by the FDA. Animal reproductive studies with doses 7 to 10 times the recommended human dosage based on body surface area (BSA) have demonstrated embryocidal and teratogenic effects. There are no controlled data in human pregnancy. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In animal studies, doses 9 times the recommended human dosage prior to and throughout gestation resulted in delayed delivery, increased postimplantation loss, decreased litter size and pup birth weight, 40% pup survival rate, 4% neonate survival, no pup survival to weaning, and increased incidence of spina bifida. Doses 9 times the maximum recommended human dosages caused a 10% abortion rate that increased to 25% at doses 18 times the maximum recommended human dosage. Doses 10 times the maximum recommended human dosage on days 6 to 15 of gestation resulted in fetal skeletal alterations (domed head, hunched shoulders, rounded body, abnormal chest, kyphosis, stunted fetuses, altered skeletal formation of ribs, sternebrae, vertebrae, and palatine). Doses 7 times the maximum recommended human dosage given day 15 of gestation through weaning cause delayed delivery, decreased live births, a 75% decrease in neonate survival, and decreased pup birth and postpartum weight. Death of 17% of fetuses occurred at doses 18 times the maximum human dosage.
Fenofibrate Breastfeeding Warnings
Because animal studies have revealed a potential for tumorigenicity, the manufacturer considers the use of fenofibrate contraindicated in nursing women.
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