Is CCRIS 8515 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use CCRIS 8515? Is CCRIS 8515 safe for nursing mother and child? Does CCRIS 8515 extracts into breast milk? Does CCRIS 8515 has any long term or short term side effects on infants? Can CCRIS 8515 influence milk supply or can CCRIS 8515 decrease milk supply in lactating mothers?

CCRIS 8515, such as fish oil or algal oil, are a rich source of omega-3 fatty acids, especially the essential fatty acids, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). Algal oil is high in DHA and low in EPA, whereas fish oil has more EPA than DHA. DHA and EPA are normal components of breastmilk in which concentrations reflect maternal intake. The DHA level in breastmilk is typically between 0.2% and 0.3% in Western countries.[1] This is usually sufficient to meet the DHA requirements of term breastfed infants, but not the higher requirements of pre-term infants, where additional maternal supplementation is needed.[2] Maternal supplementation increases breastmilk levels of DHA and EPA.[3] Higher milk levels result in higher infant plasma and erythrocyte levels of omega-3 fatty acid-derived phospholipid; one study found that breastmilk DHA was a better predictor of infant erythrocyte DHA than direct supplementation of the infants with fish oil.[4] Current dietary recommendations for nursing mothers is 250 to 375 mg daily of DHA plus EPA.[5] Lactating women require a daily dosage of about 1000 mg DHA plus EPA to reach a milk DHA plus EPA of 1 g/dL at 4 weeks postpartum.[6] Supplementation with omega-3 fatty acids has been studied for reduction of postpartum depression in nursing mothers and for improving various infant outcomes. A meta-analysis of 35 randomized, controlled trials found that women with a diagnosis of severe depression obtained benefit from omega-3 fatty acids, but those with mild depression did not.[7] A meta-analysis of randomized, controlled trials on infant neurodevelopmental outcomes found that maternal supplementation with essential fatty acids during pregnancy and breastfeeding for the first 4 months postpartum did not improve the child's problem solving ability, intelligence, or psychomotor or motor development. Weak evidence for improved vision and attention was found in one study.[8] Two meta-analyses found that maternal supplementation with omega-3-polyunsaturated fatty acids during lactation had little or no beneficial effect on childhood allergic diseases.[9][10] Another meta-analysis using different selection criteria found that supplementation of the mother with omega-3-fatty acids during pregnancy and/or breastfeeding had no beneficial effect on visual acuity, growth or language development. Some aspects of motor, cardiovascular health, behavior and immunity were found to be differentially affected by supplementation, with the more desired effect occurring more often in breastfed infants than in formula-fed infants.[11] One subsequent study found fewer allergies in the breastfed infants of supplemented mothers, but could not distinguish between supplementation during pregnancy and during breastfeeding.[12] Another study that gave fish oil to women during pregnancy and lactation found no clear benefit or harm of fish oil supplementation on children's neurodevelopment at 5 years of age.[13] Long-term follow-up of a small group of children whose mothers received fish oil supplements during lactation found that boys had a delayed puberty, shorter average height, and higher systolic blood pressure at age 13 years.[14] Another study found that maternal fish oil supplementation during pregnancy and lactation reduced oxidative stress in their breastfed infants.[15] Fish oil up to 3 grams daily is "generally recognized as safe" (GRAS) as a food by the U.S. Food and Drug Administration. The most common complaint is burping a fishy taste after ingestion. However, breast milk odor is not changed by maternal fish oil consumption.[16] Rarely, allergic reactions are reported with nut oil-derived omega-3 fatty acids in patients allergic to nuts. Dietary supplements do not require extensive pre-marketing approval from the U.S. Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to the safety and effectiveness of dietary supplements before they are marketed. Dietary supplements may contain multiple ingredients, and differences are often found between labeled and actual ingredients or their amounts. A manufacturer may contract with an independent organization to verify the quality of a product or its ingredients, but that does certify the safety or effectiveness of a product. Because of the above issues, clinical testing results on one product may not be applicable to other products. More detailed information #about dietary supplements# is available elsewhere on the LactMed Web site.

Ninety-five pregnant women at risk of having an allergic infant were randomized to daily supplements of 2.7 grams of omega-3 fatty acids (EPA 1.6 grams and DHA 1.1 grams) or a placebo from week 25 of pregnancy until 3 months of lactation. Infants of supplemented mothers had fewer allergies than unsupplemented infants, but it is unclear is the results were caused by transfer during pregnancy or during lactation.[12][26] A small sample of children whose mothers were randomized to receive either fish oil or olive oil during the first 4 months of lactation were examined at 13 years of age. Boys, but not girls, whose mothers received fish oil supplements trended towards short heights, apparently because of a delay in puberty. Boys also had a statistically significantly higher systolic blood pressure by an average of 3.9 mm Hg than girls.[14] One study found that supplementation of mothers with fish oil during pregnancy and postpartum lactation decreased plasma hydroperoxides especially in newborn at delivery and at 2.5 months of age and increased superoxide dismutase and catalase in breastfed infants newborns at 2.5 months of age. All of these changes indicate a decrease in oxidative stress in the infants.[15]