Vascepa and Pregnancy
Before taking Vascepa (icosapent ethyl) during pregnancy, women should be aware of the risks this drug may pose to an unborn child. Animal studies suggest that this medicine may harm a fetus and cause complications like skeletal abnormalities, eye problems, and even fetal death. If you are pregnant or thinking of becoming pregnant, consult your healthcare provider before taking this medicine.
Can Pregnant Women Take Vascepa?Vascepa™ (icosapent ethyl) is a prescription omega-3 fish oil medication approved to treat extremely high triglycerides. At this time, it is not clear if Vascepa is safe for use during pregnancy.
What Is Pregnancy Category C?The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is used during pregnancy. Vascepa is classified as a pregnancy Category C drug.
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to pregnant rats during animal studies, Vascepa appeared to cause a variety of defects, such as extra liver lobes, skeletal abnormalities, eye problems, and undescended testicles. In rabbits, high doses of the drug increased the risk of fetal death, which was largely due to toxicity in the mother.