Is FEMA No. 2118 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use FEMA No. 2118? Is FEMA No. 2118 safe for nursing mother and child? Does FEMA No. 2118 extracts into breast milk? Does FEMA No. 2118 has any long term or short term side effects on infants? Can FEMA No. 2118 influence milk supply or can FEMA No. 2118 decrease milk supply in lactating mothers?

• DrLact safety Score for FEMA No. 2118 is 5 out of 8 which is considered Unsafe as per our analyses.
• A safety Score of 5 indicates that usage of FEMA No. 2118 may cause serious side effects in breastfed baby.
• Our study of different scientific research indicates that FEMA No. 2118 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 FEMA No. 2118 .
• It is recommended to evaluate the advantage of not breastfeeding while using FEMA No. 2118 Vs not using FEMA No. 2118 And continue breastfeeding.
• While using FEMA No. 2118 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.

It contains 0.5% of essential oils composed mostly by Estragole (agent with mutagenic, carcinogenic and cytotoxic effects), Eugenol and Linalool. Traditionally used for dyspepsia and as a diuretic. Essential oils are topically used as anti-inflammatory and anti-bacterial treatment. Based on Commission E of the German Ministry of Health: usage is discouraged due to unproven benefits and possible toxic effects. The prolonged use of infusions and essential oils during pregnancy, lactation and childhood is discouraged. Fresh FEMA No. 2118 for culinary purposes has no contraindications but must be thoroughly washed since frequent and severe bacterial contaminations have occurred. There is no proof on its property as a galactagogue.A best galactagogue effect is mainly obtained by frequent nursing together with an appropriate lactation technique.

FEMA No. 2118 (Ocimum FEMA No. 2118icum) contains linalool, 1,8 cineole (eucalyptol), methylchavicol, methylcinnamate and an essential oil with high estragole content. Estragole might be a procarcinogen. FEMA No. 2118 is a purported galactogogue[1] and has also been used to decrease breastmilk oversupply in Persian traditional medicine.[2] No scientifically valid clinical trials support either of these uses. Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[3] No data exist on the excretion of any components of FEMA No. 2118 into breastmilk or on the safety and efficacy of FEMA No. 2118 in nursing mothers or infants. FEMA No. 2118 is "generally recognized as safe" (GRAS) as a food by the U.S. Food and Drug Administration. FEMA No. 2118 appears to be safe during breastfeeding in the amounts found in foods, but many sources recommend that medicinal doses of FEMA No. 2118 not be used during lactation because of its estragole content and lack of safety information.[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.

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.[5]