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Omega-3 polyunsaturated fatty acids Pregnancy and Breastfeeding Warnings

Omega-3 polyunsaturated fatty acids is also known as: Animi-3, Divista, EPA Fish Oil, Epanova, Fish Oil, Fish Oil Ultra, Lovaza, Marine Lipid Concentrate, MaxEPA, MaxiTears Dry Eye Formula, MegaKrill, Mom's Omega Advantage, Nature's Bounty Red Krill Oil, Omacor, Omega 3-6-9 Complex, Omega-3, Omega-500, Ovega-3 Vegetarian, Prenatal DHA, Sea-Omega, Sundown Naturals Triple Strength Red Krill Oil, Super-EPA, Systane Vitamin Omega-3 Healthy Tears, TheraTears Nutrition, Vayarin

Medically reviewed on May 5, 2017

Omega-3 polyunsaturated fatty acids Pregnancy Warnings

Animal studies showed embryocidal effects, decreased live births, and decreased neonatal survival at doses equivalent to 7 times the recommended human dose (of 4 grams/day); lower doses showed no adverse effects. Maternal toxicity occurred at 4 times the human dose (over 750 mg/kg/day) in animal studies. There are no controlled data in human pregnancy. Adequate omega-3 fatty acid intake during pregnancy may reduce preterm birth, increase birth length, weight, and head circumference, improve cognitive and visual development, and reduce risk of allergies.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: C

Comments:
-There is no official RDA for omega-3 fatty acids during pregnancy, but the US Institute of Medicine and the Food and Nutrition Board suggest that 1400 mg per day should be adequate during lactation.
-Pregnant women may not consume adequate amounts of omega-3 fatty acids from their diet due to recommendations to limit fish consumption to no more than twice weekly (due to mercury content of fish).

See references

Omega-3 polyunsaturated fatty acids Breastfeeding Warnings

Use is not recommended.
Safety has not been established.

Excreted into human milk: Yes

Comments:
-Animal studies showed drug levels 6 to 14 times higher in milk than in plasma.
-Effects on infants are unknown; use with caution.
-Infant needs for docosahexaenoic acid (DHA) is approximately 70 to 80 mg per day.
-There is no official RDA for omega-3 fatty acids during lactation, but the US Institute of Medicine and the Food and Nutrition Board suggest that 1300 mg per day should be adequate during lactation.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Omega-3 D-3 Wellness Pack (omega-3 polyunsaturated fatty acids)." TMIG Inc, Marietta, GA.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Lovaza (omega-3 polyunsaturated fatty acids)." GlaxoSmithKline, Research Triangle Park, NC.
  6. "Product Information. Omega-3-Acid Ethyl Esters (omega-3 polyunsaturated fatty acids)." Apotex Corporation, Weston, FL.

References for breastfeeding information

  1. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  2. "Product Information. Omega-3 D-3 Wellness Pack (omega-3 polyunsaturated fatty acids)." TMIG Inc, Marietta, GA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Omega-3-Acid Ethyl Esters (omega-3 polyunsaturated fatty acids)." Apotex Corporation, Weston, FL.

Further information

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

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