Question

I am a breastfeeding mother and i want to know if it is safe to use UNII-CS4U38E731? Is UNII-CS4U38E731 safe for nursing mother and child? Does UNII-CS4U38E731 extracts into breast milk? Does UNII-CS4U38E731 has any long term or short term side effects on infants? Can UNII-CS4U38E731 influence milk supply or can UNII-CS4U38E731 decrease milk supply in lactating mothers?

Answer by DrLact: About UNII-CS4U38E731 usage in lactation

UNII-CS4U38E731 (Nigella sativa) contains an essential oil containing a wide variety of terpenes, thymoquinone, beta-elemene and other many constituents. UNII-CS4U38E731 has been used orally as a galactogogue in India and Iran;[1][2][3] however, no scientifically valid clinical trials support this use. Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[4] The oil has also been used topically. No data exist on the excretion of any components of UNII-CS4U38E731 into breastmilk or on the safety and efficacy of UNII-CS4U38E731 in nursing mothers or infants. Limited information indicates that UNII-CS4U38E731 is generally well tolerated. UNII-CS4U38E731 oil can cause allergic contact dermatitis. 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.

UNII-CS4U38E731 Possible Effects in Breastfeeding

One hundred fifty-eight mothers in Iran of who reported difficulty in breastfeeding were given either a proprietary mixture of herbs (Shirafza Drop) or a chlorophyll solution as a placebo. The herbal mixture contained the purported galactogogues fennel, anise, cumin, UNII-CS4U38E731, and parsley. Infant ages ranged between 0 and 6 months and they were exclusively breastfed. Weight gain of the infants was measured over time. No difference in infant weight gain was seen between the two groups of infants.[5] Blinding and randomization in this study is unclear.

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