Animal studies of oral administration from 2 weeks prior to mating through lactation showed no adverse effects at 5 times the recommended human dose (MRHD). A dose ranging study of oral administration from 2 weeks prior to mating to postpartum day 7 showed a 20% reduction in live births and a 40% reduction in pup survival to postnatal day 4 at or above 3000 mg/kg/day (7 times the MRHD). Oral doses up to 14 times the MRHD (a maternotoxic dose) administered during organogenesis showed no fetal adverse effects. Animals given oral doses up to 5 times the MRHD from gestation day 14 through lactation day 21 showed no adverse effects. Skeletal malformations and reduced fetal growth were seen at maternally toxic doses (4 times the MRHD) and embryolethality occurred at 7 times the MRHD in rabbits. 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. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.


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 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.

Use is recommended only if clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Comments:
-There is insufficient data on use in pregnancy to identify drug-associate risks for major birth defects, miscarriage, or adverse fetal or maternal outcomes.
-Animal studies of dams given oral omega-3-acid ethyl esters from mating through lactation did not show adverse reproductive or developmental effects at 5 times the maximum recommended human dose (MRHD).
-Animal studies of oral dosing at clinically relevant doses during organogenesis did not show teratogenicity.
-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

Safety has not been established; use is not recommended.

Excreted into human milk: Yes

Comments:
-There is no information regarding this drug on the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-Higher omega-3 fatty acid levels have been seen in lactating patients receiving oral omega-3 fatty acid supplementation.
-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