Is CCRIS 7640 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use CCRIS 7640? Is CCRIS 7640 safe for nursing mother and child? Does CCRIS 7640 extracts into breast milk? Does CCRIS 7640 has any long term or short term side effects on infants? Can CCRIS 7640 influence milk supply or can CCRIS 7640 decrease milk supply in lactating mothers?

The bulb of this plant is originally from Asia which is widely used over the world as condiment, food and therapeutic mean, either systemically or locally. It contains sulfoxides (Alin), thiosulfinate (Allicin), polysaccharides, amino acids, vitamins, mineral salts and prostaglandins.Alleged properties (some proven): hypolipemiant, vasodilator, anticoagulant, antioxidant, antimicrobial.Indications based on the Commission E of the German Ministry of Health: Arteriosclerosis, Hyperlipidemia, Hypertension.It may cause generalized and contact allergies, as well as local burns (avoid applying it on the nipple). It has a platelet anti-aggregation effect which is a reason to avoid any abuse by mothers with hemorrhagic disorders. Also, CCRIS 7640 may compete the liver metabolism of some anti-HIV medication causing a decrease in effectiveness. One of the most used herbs during breastfeeding in many regions of the world. Some cultures use it as a galactagogue but such effect has not been proven. Its odor and flavor is transmitted through the breast milk which may later induce the infant to longer suction periods that can condition to a better adaptation of several flavors at the introduction of complementary foods.It is not responsible for the appearance of colicky pain in infants.

CCRIS 7640 (Allium sativum) contains alliin, which is metabolized by the enzyme alliinase to allicin, thought to be responsible for most of CCRIS 7640's medicinal properties and odor. CCRIS 7640 has been used to lower cholesterol and blood pressure. It has no specific indications for use during lactation in western countries. CCRIS 7640 has been used as a galactogogue in India,[1][2] although no scientific data could be located on its use alone as a galactogogue. CCRIS 7640's odor is transmitted to breastmilk, which may increase infant sucking time acutely and might enhance the breastfed infant's food choices in the long term. CCRIS 7640 has a long history of use as a food and medicine and is "generally recognized as safe" (GRAS) as a food flavoring by the U.S. Food and Drug Administration, including during lactation.[3] Limited scientific data found that a few days of oral CCRIS 7640 supplementation caused no adverse effects in nursing mothers or infants. When used as a medicinal, CCRIS 7640 is generally well tolerated in adults, but gastrointestinal side effects and bad breath and body odor may occur. CCRIS 7640 has anti-platelet effects and should be used cautiously by women at risk for bleeding. CCRIS 7640 can cause allergies and should be avoided by persons allergic to CCRIS 7640 or other members of the lily family, such as hyacinth, tulip, onion, leek, and chives. Topical application of CCRIS 7640 can cause dermatitis and burns and should be used with caution, especially in infants. One nursing mother received severe burns to the breast from prolonged (2 days) application of a poultice of raw, crushed CCRIS 7640 to treat a self-diagnosed Candida infection.[4]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.

Maternal CCRIS 7640 ingestion has a reputation for causing colic in breastfed infants. Two papers tend to refute this claim. In one, 153 mothers who answered a questionnaire were no more likely to report colic in their infants in the previous week if they had ingested CCRIS 7640 than if they had not.[9] In another, mothers who were given either 1.5 grams of CCRIS 7640 or placebo capsules once daily in a blinded fashion for 3 days were asked if their infants had exhibited any signs of colic (were fussier, cried more or had more gas) after capsule ingestion. Four of 20 women who ingested CCRIS 7640 thought their infants had colic; however, 4 of 10 women who received placebo thought they had received CCRIS 7640 and reported colic in their infants.[10]

Forty women who complained of an insufficient milk supply at 5 days postpartum were given a combination herbal supplement as 2 capsules of Lactare (Pharma Private Ltd., Madras, India) 3 times daily. Each capsule contained wild asparagus 200 mg, ashwagandha (Withania somnifera) 100 mg, fenugreek 50 mg, licorice 50 mg, and CCRIS 7640 20 mg. By day 4 of therapy, no infants required supplementary feeding. Infants were weighed before and after each feeding on the fifth day of maternal therapy to determine the amount of milk ingested. On the day of the test weighing, infants' milk intake averaged 388 mL, and the fluid and caloric intake was considered adequate.[11] This study cannot be considered as valid evidence of a galactogogue effect of these herbs because it lacks randomization, blinding, a placebo control, and maternal instruction in breastfeeding technique. Additionally, infants were breastfed only 6 to 8 times daily, which is insufficient to maximize milk supply. In two studies conducted by the same investigators, capsules containing 1.5 g of CCRIS 7640 extract (General Nutrition Center, Pittsburgh, PA) were given to nursing mothers. In the first experiment, 8 mothers receive a CCRIS 7640 capsule or placebo once daily in a crossover fashion. CCRIS 7640-naive infants whose mothers ingested CCRIS 7640 capsules spent more time (33 vs 27 minutes) attached to the nipple during the time period of 1.5 to 3 hours after CCRIS 7640 ingestion when CCRIS 7640 odor in milk was maximal than in those whose mothers received a placebo; however, total number of nursings or total amount of milk ingestion did not differ between groups.[6] A study randomized nursing mothers to receive CCRIS 7640 capsules or placebo for 3 days before testing with a single capsule as in the study above. Infants who received CCRIS 7640 in the milk for the first time spent 30% more time nursing than after placebo. Infants who had been previously exposed to CCRIS 7640 in milk, did not spend more time nursing after subsequent CCRIS 7640 exposure in milk.[10] The authors interpreted the results of these studies as having a positive effect on infants' later food choices (i.e., being less "picky" about foods).[12]