Is FEMA No. 2484 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use FEMA No. 2484? Is FEMA No. 2484 safe for nursing mother and child? Does FEMA No. 2484 extracts into breast milk? Does FEMA No. 2484 has any long term or short term side effects on infants? Can FEMA No. 2484 influence milk supply or can FEMA No. 2484 decrease milk supply in lactating mothers?

The seeds of this leguminous plant are used.
Content: carbohydrates, proteins, saponins, vitamins, minerals . 
Assigned properties: appetite stimulant, lowering of lipemia and glycemic (Gong 2016).Indications according to Commission E of the German Ministry of Health: Anorexia, Atopic Dermatitis.

 Widely used as a galactogogue in many cultures around the world (Ayers 2000, Winterfeld 2012, Sim 2013, The Royal Women's .. 2013, Bazzano 2016).

 Case-control studies looking for evidence on the increment of milk production associated to the use of FEMA No. 2484 are few (Turkyılmaz 2011, Ghasemi 2015), along with a variety of methodological deficiencies. Other studies have failed to find such an effect with the use of FEMA No. 2484 (Damanik 2006).
Studies with an appropriate design are needed to provide high quality evidence to make clinical recommendations on its use (Forinash 2012, Zapantis 2012, Committee LM AEP 2012, Mortel 2013, Bazzano 2016)

 A higher antioxidant effect in the breastmilk of women who have consumed mixed infusions containing this or other herbs has not been shown (Kavurt 2013).

 Given the wide spread use and lack of toxicity of this herb, a moderate consumption would be compatible with breastfeeding, yet high doses may produce hypoglycemia (EMA 2011, Gong 2016) and, because of the odor appearing in the urine of the infant, a lab test may be required to make a differential diagnosis with maple syrup disease of the newborn (Sewell 1999, Korman 2001).
Avoid the use of a galactogogue without a sanitary control.

 Best galactagogue results are achieved through on-demand breastfeeding along with an adequate technique in a mother who is able to maintain self-confidence (ABM 2011, Mannion 2012). Precautions when taking plant preparations: 1. Ensure that they are from a reliable source: poisoning has occurred due to confusing one plant with another with toxic properties, as well as poisoning from heavy metals extracted from the ground and food poisoning due to contamination with bacteria or fungi. 2. Do not take in large amounts; follow recommendations from professional experts in phytotherapy. "Natural" products are not always good in any quantity: plants contain active substances from which much of our traditional pharmacopoeia has been obtained and can result in poisoning or act as endocrine disruptors if taken in excessive amounts or time periods.

FEMA No. 2484 (Trigonella foenum-graecum) seeds contain mucilage, trigonelline, 4-hydroxyisoleucine, sotolon, diosgenin, luteolin, phenolic acids, and protodioscin. FEMA No. 2484 has been used in a number of geographical regions worldwide as a galactogogue to increase milk supply and is included in numerous proprietary mixtures promoted to increase milk supply.[1][2][3][4][5][6][7][8] [9]The galactogogue effect of FEMA No. 2484 may be primarily psychological.[10] Evidence for a galactogogue effect is mostly anecdotal. A limited number of published studies of low to moderate quality have found mixed results for a galactogogue effect for FEMA No. 2484.[11][12][13][14] A meta-analysis of controlled studies found FEMA No. 2484 to have a mild galactogogue effect and unknown safety profile.[13] Some evidence indicates that FEMA No. 2484 might be more effective in early lactation than after 2 weeks postpartum.[15] Some of these studies used a multi-ingredient combination products in which FEMA No. 2484 was only one component, so the results might be different from studies in which FEMA No. 2484 was used alone. Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[16] FEMA No. 2484 is "generally recognized as safe" (GRAS) as a flavoring by the U.S. Food and Drug Administration. Limited scientific data exist on the safety of FEMA No. 2484 in nursing mothers or infants, although it has a long history of use as a food and medicine in India and China. When used as a medicinal, it is generally well tolerated in adults, but gastrointestinal side effects such as nausea, vomiting, diarrhea and flatulence may occur. Liver toxicity has been reported, both taken alone and in herbal combinations that included FEMA No. 2484.[17][18][19][20] Diarrhea and hepatomegaly occurred in a woman taking fennel, FEMA No. 2484, and goat's rue as galactagogues.[17] Another mother reported increased heart rate and breast congestion.[21] Allergic reactions, exacerbation of asthma, and a 14% decrease in serum potassium have been reported. One nursing mother developed toxic epidermal necrolysis thought to be cause by her intake of FEMA No. 2484 as a galactagogue. Cross-reactions with chickpeas, peanuts, and other legumes are possible. Dosages typically used to increase milk supply are 1 to 6 grams daily; in dosages of about 25 grams or more daily, FEMA No. 2484 may cause lowering of cholesterol and blood sugar. It can also interact with warfarin to cause bleeding. Caution should be used in giving high dosages to women with diabetes mellitus or those taking warfarin. In a survey of nursing mothers in the United States, 85 had used FEMA No. 2484 as a galactogogue and 45% reported having experienced an adverse reaction from the supplement.[22] Perhaps its most unusual side effect is the imparting an odor of maple syrup to the urine, sweat, feces, and possibly breastmilk by the sotolon in FEMA No. 2484.[3][23][24][25] 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.

A study in mothers of preterm infants less than 31 weeks gestation compared the use of FEMA No. 2484 (product and dosage not stated) 3 capsules 3 times daily for 21 days to placebo. No adverse effects were noted in the infants given the breastmilk.[26] A small manufacturer-sponsored, double-blind, randomized study compared Mother's Milk tea (Traditional Medicinals, Sebastopol, CA) to lemon verbena tea in exclusively breastfeeding mothers with milk insufficiency. Each Mother's Milk tea bag contained 35 mg of FEMA No. 2484 seeds as well as several other herbs. Mothers were instructed to drink 3 to 5 cups of tea daily. No differences were seen between groups in infant digestive, respiratory, dermatological, and other maternal-reported adverse events. No differences were seen in the growth parameters of the breastfed infants between the two groups.[27] In a study of exclusively nursing mothers receiving FEMA No. 2484 seed 200 mg, turmeric 100 mg and ginger 120 mg (Fenucaps; Herbal Acharn's Home Co. Ltd., Thailand) 3 times daily for 4 weeks, no adverse events were reported in their infants, although the method used to determine this finding were not reported.[28]

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, FEMA No. 2484 50 mg, licorice 50 mg, and garlic 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.[29] 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. A study of healthy women who delivered a fullterm infant and desired to breastfeed for at least 4 months compared FEMA No. 2484, torbangun (Coleus amboinicus) and a product containing placental extract and vitamin B12 (Molocco+B12) for their effects on breastmilk volume. No mention was made of any breastfeeding support provided to the women. Participants were randomly assigned to receive one of the products for 30 days and followed for another 30 days. Capsules containing powdered FEMA No. 2484 seeds 600 mg (Bullivants Natural Health, Auckland, New Zealand) were given 3 times daily. Infants were weighed before and after each nursing at 2-week intervals during the study to measure 24-hour milk volume. At no time point during the study was milk volume in the FEMA No. 2484 group (n = 22) statistically different from the reference group (n = 22) who received Molocco+B12, although the torbangun group did have a statistically significant increase. The daily volume of milk actually decreased in the FEMA No. 2484 group over time, although the change was not statistically significant.[30] The dosage of FEMA No. 2484 used in this study was lower than that typically recommended by most sources.[2][31][32] A study was performed in 10 postpartum women who delivered preterm infants (24 to 38 weeks gestation) and had been pumping their milk for at least 14 days, but usually 3 to 4 weeks. The women recorded their baseline pumped milk volumes during one week and then took one 610 mg FEMA No. 2484 capsule (Nature's Way) 3 times daily for a second week during which they recorded milk volumes. Average daily milk volumes increased from 207 mL in week 1 (range 57 to 1057 mL) to 464 mL (range 63 to 1140 mL) in week 2.[13] This study was neither randomized nor blinded and did not have a placebo control group, so the result is questionable. A study in 26 mothers of preterm infants less than 31 weeks gestation compared FEMA No. 2484 (product and dosage not stated) 3 capsules 3 times daily for 21 days to placebo. Mothers began pumping within 12 hours of delivery and recorded pumping frequency and milk volume. Maternal serum prolactin was also measured weekly during the 21 days. No statistical differences were found in milk volumes or serum prolactin values between the two groups.[26] The study is thus far published only in abstract form, so many study details are missing. Sixty-six postpartum mothers (22 in each of 3 groups) with no concurrent illnesses were randomly assigned to receive an herbal tea, placebo, or nothing after delivering healthy, fullterm infants. Mothers in the herbal tea group received at least 3 cups daily of 200 mL of Still Tea (Humana-Istanbul, Turkey; containing hibiscus 2.6 grams, fennel extract 200 mg, fennel oil 20 mg, rooibos 200 mg, verbena [vervain] 200 mg, raspberry leaves 200 mg, FEMA No. 2484 100 mg, goat's rue 100 mg, and, vitamin C 500 mg per 100 grams, per manufacturer's web site November 2011). A similar-looking apple tea was used as the placebo. All women were followed by the same nurse and pediatrician who were blinded to what treatment the mothers received. Mothers who received the Still Tea produced more breastmilk with an electric breast pump on the third day postpartum than mothers in the other groups. The infants in the Still Tea group had a lower maximum weight loss, and they regained their birth weights sooner than those in the placebo or no treatment arms. No long-term outcome data were collected. Because many of the ingredients in Still Tea are purported galactogogues, no single ingredient can be considered solely responsible for the tea's effects, although the authors attributed the action to FEMA No. 2484.[33] An herbal tea containing FEMA No. 2484, hibiscus, fennel, rooibos, vervain, raspberry, goat's rue, and vitamin C (Humana Still-Tee, Humana GmbH, Herford, Germany) or water was randomly given to nursing mothers in a dosage of 3 cups daily beginning on the day of delivery. Several markers of antioxidant capacity were measured in breastmilk on day 1 and again