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Icosapent Pregnancy and Breastfeeding Warnings

Icosapent is also known as: Vascepa

Medically reviewed by Drugs.com. Last updated on Feb 13, 2020.

Icosapent Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: The available data in pregnant women is insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes; in pregnant rats, non-dose-related imbalances for some minor developmental findings were observed with administration during organogenesis at exposures equivalent to the human dose.

In pregnant rats, non-dose-related imbalances for some minor developmental findings (e.g., 13th reduced ribs, additional liver lobes, testes medially displaced and/or not descended) were observed with oral administration of this drug during organogenesis at exposures equivalent to the human dose of 4 g/day. In pregnant rabbits administered this drug during organogenesis, there were no clinically relevant adverse developmental effects at exposures that were 5 times the human dose. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Icosapent Breastfeeding Warnings

Drug levels 6 to 14 times higher in milk than in plasma have been demonstrated in lactating rats.

Caution is recommended

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Vascepa (icosapent)." Amarin Pharmaceuticals Inc, Warren, NJ.

References for breastfeeding information

  1. "Product Information. Vascepa (icosapent)." Amarin Pharmaceuticals Inc, Warren, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.