Vascepa Use In Pregnancy & Lactation

Pregnant Women: There are no adequate and well-controlled studies that evaluated the use of VASCEPA in pregnant women. In animal reproduction studies in pregnant rats, oral administration of icosapent ethyl or eicosapentaenoic acid (EPA) ethyl ester during organogenesis resulted in fetal visceral or skeletal abnormalities, increased incidence of absent optic nerves, and unilateral testes atrophy even at doses below an equivalent to the clinical dose of 4 g/day based on a comparison of body surface area, for a 60 kg human (see Pharmacology: Toxicology: Non-clinical Toxicology: Reproductive and Developmental Toxicology under Actions). ¹⁴C-labelled ethyl-EPA given orally to pregnant dams was shown to transfer to the fetus, especially in early gestation (gestation day 12) during which peak concentrations in fetuses and placentas reached 1.9- and 3.6-times the concentration in maternal plasma, respectively, at 24 hours post-administration.
Therefore, the use of VASCEPA is not recommended during pregnancy.
Breast-feeding: There is no information regarding the presence of VASCEPA in human milk, the effects on the breastfed infant, or the effects on milk production. However, studies with other omega-3-acid ethyl esters have demonstrated excretion in human milk, therefore VASCEPA may also be excreted in human milk. An animal study in lactating rats given one dose of ¹⁴C-labelled ethyl-EPA by oral gavage demonstrated that EPA levels were 6 to 14 times higher in milk than in plasma at their maximum, 24 hours post-administration. After 96 hours (4 days), the concentration of EPA measured in milk was still 20% of the peak values.
The use of VASCEPA in nursing women is not recommended (see Pharmacology: Toxicology: Non-clinical Toxicology: Reproductive and Developmental Toxicology under Actions).