Is EINECS 294-446-5 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use EINECS 294-446-5? Is EINECS 294-446-5 safe for nursing mother and child? Does EINECS 294-446-5 extracts into breast milk? Does EINECS 294-446-5 has any long term or short term side effects on infants? Can EINECS 294-446-5 influence milk supply or can EINECS 294-446-5 decrease milk supply in lactating mothers?

• DrLact safety Score for EINECS 294-446-5 is 5 out of 8 which is considered Unsafe as per our analyses.
• A safety Score of 5 indicates that usage of EINECS 294-446-5 may cause serious side effects in breastfed baby.
• Our study of different scientific research indicates that EINECS 294-446-5 may cause moderate to high side effects or may affect milk supply in lactating mother.
• Our suggestion is to use safer alternate options rather than using EINECS 294-446-5 .
• It is recommended to evaluate the advantage of not breastfeeding while using EINECS 294-446-5 Vs not using EINECS 294-446-5 And continue breastfeeding.
• While using EINECS 294-446-5 Its must to monitor child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to 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.

Ripe fruits are used. It contains heterosidic iridoid, estrogen-like flavonoids, terpenes and linoleic acid. Although traditionally used as a galactagogue, it contains diterpenes that have a dopamine-like effect which is inhibitory of prolactin release and milk production. Indications approved by the Commission E of the German Ministry of Health are: Irregularity of menses, pre-menstrual syndrome, mastodinia.

EINECS 294-446-5 (Vitex agnus-castus) is the fruit (berries) from the chaste tree. The berries contain essential oils (e.g., limonene, sabinene, 1,8-cineole [eucalyptol]), iridoid glycosides (e.g., agnoside, aucubin), diterpines (e.g., vitexilactone, rotundifuran), and flavonoids (e.g., apigenin, castican, orientin, isovitexin). EINECS 294-446-5 is often used for irregularities of the menstrual cycle, infertility, premenstrual complaints, and cyclical breast pain.[1][2] Some constituents, possibly the diterpene clerodadienols, bind to dopamine D2 receptors in the pituitary.[3] In low doses, EINECS 294-446-5 increases serum prolactin and it is a purported galactogogue;[4][5][6] however, no scientifically valid clinical trials support this use and galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[7] Some evidence indicates that high doses of EINECS 294-446-5 decrease serum prolactin and might decrease lactation.[8] It has been used to decrease breastmilk oversupply in Persian traditional medicine.[9] In general, EINECS 294-446-5 is well tolerated. The most frequent adverse events are nausea, headache, gastrointestinal disturbances, menstrual disorders, acne, pruritus, and erythematous rash; however, all are mild and reversible. Among 352 nursing mothers given EINECS 294-446-5 tincture, 15 cases of pruritus, exanthema, urticaria, and some cases of early menstrual period occurred. Because of concerning safety data and possible lactation suppression, EINECS 294-446-5 should be avoided during lactation.[10] 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.

Nursing mothers who were participating in an experiment on the excretion of 1,8-cineole (eucalyptol) in breastmilk took a 100 mg capsule of 1,8-cineole orally. Although instructed not to, 12 mothers breastfed their infants during the experiment. Mothers reported that none of their infants refused their milk or breastfed less than usual. Two mothers felt that their infants were more agitated a few hours after breastfeeding. A third mother reported that the infant stopped nursing from time to time and "looked puzzled", but resumed nursing. Upon repeating the experiment 6 weeks later, the infant did not react in an unusual way during breastfeeding.[11]

In an old, uncontrolled, nonblinded case series, Agnus castus oligoplex (Madaus [Germany]) was used to increase lactation. One hundred twenty-five hospitalized postpartum mothers were given the product, which was obtained from the seed of the chaste tree, in a dosage of 30 drops 3 times a day. In cases with poor response the dose was increased to 30 and 50 drops a day. Of the 125 mothers, 100 responded and left the hospital nursing their infants. Of these, 61% nursed completely, and 39% only partially. Most of the latter were primiparous women or women who had not nursed their first child. The drug reportedly lost its effectiveness over time.[14] The methodology used in this paper does not meet current standards and cannot be considered as proof of a galactogogue effects of EINECS 294-446-5. A nonrandomized, partially blinded study compared a EINECS 294-446-5 preparation (Agnolyt, Madaus [Germany]) 15 drops 3 times daily to one tablet of thiamine 3 times daily in postpartum mothers. Milk production was measured by the average change in weight of infants of 353 mothers treated with EINECS 294-446-5, 102 cases were treated with thiamine, and 362 untreated patients served as controls. No difference in milk production was noted until about 14 days postpartum. After that time, the mothers who received EINECS 294-446-5 had greater milk production than those in the other groups. The effect appeared to be greater in patients with cesarean section or complications such as fever.[15] The methodology used in this study does not meet current standards and cannot be considered as proof of a galactogogue effects of EINECS 294-446-5. A double-blind study of 52 women with hyperprolactinemia compared 20 mg daily of a EINECS 294-446-5 preparation (Strotan, Stroschein Pharma [Germany]) to placebo. After 3 months of therapy, the prolactin response to intravenous thyrotropin releasing hormone was reduced and menstrual irregularities were reduced in the subjects taking EINECS 294-446-5.[16] In an open study of 20 healthy males, a special Agnus castus extract (BP1095E1, equivalent to 40 mg extract of EINECS 294-446-5) was studied in doses of 120 mg, 240 mg and 480 mg daily in 3 divided doses. Each subject received placebo and each of the doses for 14 days, followed by 1 drug-free week. Total prolactin secretion was measured on the last day of each study period. Following stimulation by thyrotropin releasing hormone, the 120 mg dose increased serum prolactin by an average of about 16% and the 480 mg dose decreased prolactin by an average of about 10%; the 240 mg dose was approximately neutral with respect to placebo.[17] A randomized study compared EINECS 294-446-5 extract 40 mg daily (Agnucaston, Biomeks [Germany]) to bromocriptine 2.5 mg twice daily in 2 groups of 40 women. One group had mild hyperprolactinemia and the other had cyclic mastalgia. After 3 months of treatment, serum prolactin on day 3 to 5 of the menstrual cycle decreased by an average of 44% to 47% in all groups. No statistical difference was found between the 2 treatments in their prolactin-lowering effect.[18] An 18-year old woman with amenorrhea, galactorrhea, and an elevated serum prolactin caused by a microprolactinoma began taking 15 drops of a EINECS 294-446-5 preparation containing 9 grams of EINECS 294-446-5 tincture per 100 grams of solution (Agnolyt, Madaus [Germany]) each morning. After 3 months her menstrual cycle had normalized, galactorrhea had ceased, and serum prolactin had decreased by 27% (although still elevated).[19]