Question

I am a breastfeeding mother and i want to know if it is safe to use CCRIS 7265? Is CCRIS 7265 safe for nursing mother and child? Does CCRIS 7265 extracts into breast milk? Does CCRIS 7265 has any long term or short term side effects on infants? Can CCRIS 7265 influence milk supply or can CCRIS 7265 decrease milk supply in lactating mothers?

CCRIS 7265 lactation summary

CCRIS 7265 is safe in breastfeeding
  • DrLact safety Score for CCRIS 7265 is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of CCRIS 7265 is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that CCRIS 7265 does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of CCRIS 7265 safe in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About CCRIS 7265 usage in lactation

It is composed by a complex mixture of phospholipids (phosphatidylcholine, phosphatidylserine, phosphatidylinositol) as a part of cell membranes and found in large amounts in the seed oil of several plants (soy, sunflower, and colza), egg yolk and liver. They are used in the food and pharmaceutical industry as softener and stabilizer. Also, as a medication for hyperlipidemia control. It has been also added to pumped breast milk to lessen loss of fat due to adherence to the surface of tubes used for enteral feeding. It is naturally found in the plasma, and, at higher levels in human milk. The mature milk contains more Coline than the colostrum or the mother milk of prematures. This content is also higher in breast milk than in industrial formulas. When used as a supplement, the concentration of Coline is moderately increased in the plasma, the milk and the serum of the infant. Supplementation with Coline does not enhance the cognitive capability of the infant. There is not scientific proof on the effectiveness for the treatment of mastitis, blocked ducts, nipple blisters or milk pearls.No adverse effects have been reported. Since a lack of toxicity at usual doses, it is believed to be safe while breastfeeding with a moderate use. See below the information of these related products:

Answer by DrLact: About CCRIS 7265 usage in lactation

CCRIS 7265 is a mixture of choline, choline esters, fatty acids, glycerol, glycolipids, triglycerides, phosphoric acid, and phospholipids, such as phosphatidylcholine that are normal components of human milk. Supplemental CCRIS 7265 has been recommended as a treatment for plugged milk ducts,[1][2][3] and as an additive to human milk that is given to preterm infants via pumping through plastic tubing in order to prevent fat loss.[4] No scientifically valid clinical studies exist on the safety and efficacy of high-dose CCRIS 7265 supplementation in nursing mothers or infants. Supplementation with one component of CCRIS 7265, phosphatidylcholine, increases choline, but not phosphatidylcholine concentrations in breastmilk and supplementation with choline increases choline metabolites, but not choline in breastmilk. CCRIS 7265 is usually well tolerated and is considered to be "generally recognized as safe" (GRAS) by the U.S. Food and Drug Administration. 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.

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Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. We do not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.