Also known as , A-60386X, A-855071.0, ABT-263, ABT-510, ADH-1, AT9283, ATN-161, AVR118, AZD2171, AZD2171 Maleate, Acetophenone, Aurora kinase inhibitor AT9283, Beractant, CC-8490, Cediranib Maleate, Exherin, Immunomodulator OHR/AVR118, Multikinase Inhibitor AT9283, Navitoclax, OGX-011, Product R, Recentin, SPC8490, Survanta, custirsen
Summary of use during lactation
Fennel (Foeniculum vulgare) seeds contain the volatile oil composed largely of anethole, which is a phytoestrogen, as well as fenchone, estragole, 1,8-cineole (eucalyptol), and other constituents. Fennel is a purported galactogogue[1][2][3][4][5][6][7][8][9][10][11] and is included in some proprietary mixtures promoted to increase milk supply. No scientifically valid clinical trials support this use, although one old, small study found an increase in milk volume and fat content with fennel therapy. Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[12] Immersing the breast in a warm infusion of fennel seeds and marshmallow root has been suggested as a treatment for breast inflammation,[13] but no scientific data are available that support this use. Anethole is excreted in breastmilk.[14] Fennel is generally well tolerated in adults, and fennel oil is “generally recognized as safe” (GRAS) for use in food by the US Food and Drug Administration. It has been safely and effectively used alone and with other herbs in infants for the treatment of colic,[15][16][17] so the smaller amounts in breastmilk are likely not to be harmful with usual maternal doses. Some sources recommend limiting the duration of treatment to 2 weeks. Excessive maternal use of an herbal tea containing fennel, anise and other herbs appeared to cause toxicity in 2 breastfed newborns that was consistent with toxicity caused by anethole, which is found in fennel and anise. Fennel can cause allergic reactions after oral or topical use affecting the respiratory system or skin, including photosensitivity. Avoid excessive sunlight or ultraviolet light exposure while using this herbal. Fennel should be avoided by mothers if they or their infants are allergic to carrots, celery, or other plants in the Apiaceae family because of possible cross-allergenicity.
Dietary supplements do not require extensive pre-marketing approval from the US Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to prove 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 not 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.
Drug levels
Maternal Levels. Eighteen lactating women were given 100 mg of trans-anethol in a capsule on 3 test days. Milk samples were collected every 2 hours for 8 hours starting at the time of ingestion. Trans-anethol was detected in milk at all collection times, with the average concentrations of 2 mcg/L at 0 hours, 9.9 mcg/L at 2 hours, 9.2 mcg/L at 4 hours, 7.3 mcg/L at 6 hours and 4.3 mcg/L at 8 hours after the dose. The average peak anenthol concentration in milk was 23.2 mcg/L. Only small amounts of anenthol glucuronide metabolites were present in the milk samples.[14]
Twelve nursing mothers who were19 weeks to 19 months postpartum ingested 100 mg of 1,8 cineole (eucalyptol) in the form of delayed-release capsules (Soledum-Klosterfrau Vertriebs GmbH, Germany) that release the drug in the intestine. Then they pumped 1 to 4 milk samples at the time they perceived the smell of eucalyptus on their breath which had been previously shown to be approximately concurrent. A total of 21 milk samples were obtained. Odor was rated by a panel of 3 to 5 experts as either smelling like eucalyptus or not. Fourteen of the samples had a distinct eucalyptus-like odor. Chemical analysis of the positive odor tests found 1,8-cineole in concentrations from 70 to about 2090 mcg/kg of milk, most in the range of 100 to 500 mcg/kg of milk. Samples with negative odor tests contained concentrations in the range of 0.98 to about 20.23 mcg/kg of milk. In one woman who donated 3 samples, the highest concentration of 71 mcg/kg occurred at 1.5 hours after ingestion, with concentrations of 1 mcg/kg before ingestion and 15 mcg/kg at 9.5 hours after ingestion.[18] Eight women had their milk analyzed for 1,8-cineole metabolites. Ten metabolites and several enantiomers of these metabolites were detected.[19][20]
Five women who were nursing infants between 6 and 55 weeks of age drank 950 mL of fennel-anise-caraway tea (Messmer Ostfriesische Tee Gesellschaft Laurens Spethmann GmbH & Co. KG, Seevetal, Germany). The main odorant components of the tea are the following terpenes: limonene, 1,8-cineole, fenchone, estragole, carvone, trans-anethole, p-anisaldehyde and anisketone. Mothers collected milk samples at 30 minutes, 1 and 2 hours after ingesting the tea. Ingestion of the tea did not increase the overall terpene content of the milk, but there was wide variation from mother to mother. Some mothers had high background levels of some terpenes, probably from other foods or person care products. In addition, a sensory panel found no significant change in the odor profile of the breastmilk samples compared to blank samples.[21]
Infant Levels. Relevant published information was not found as of the revision date.
Effects in breastfed infants
Maternal Levels. Eighteen lactating women were given 100 mg of trans-anethol in a capsule on 3 test days. Milk samples were collected every 2 hours for 8 hours starting at the time of ingestion. Trans-anethol was detected in milk at all collection times, with the average concentrations of 2 mcg/L at 0 hours, 9.9 mcg/L at 2 hours, 9.2 mcg/L at 4 hours, 7.3 mcg/L at 6 hours and 4.3 mcg/L at 8 hours after the dose. The average peak anenthol concentration in milk was 23.2 mcg/L. Only small amounts of anenthol glucuronide metabolites were present in the milk samples.[14]
Twelve nursing mothers who were19 weeks to 19 months postpartum ingested 100 mg of 1,8 cineole (eucalyptol) in the form of delayed-release capsules (Soledum-Klosterfrau Vertriebs GmbH, Germany) that release the drug in the intestine. Then they pumped 1 to 4 milk samples at the time they perceived the smell of eucalyptus on their breath which had been previously shown to be approximately concurrent. A total of 21 milk samples were obtained. Odor was rated by a panel of 3 to 5 experts as either smelling like eucalyptus or not. Fourteen of the samples had a distinct eucalyptus-like odor. Chemical analysis of the positive odor tests found 1,8-cineole in concentrations from 70 to about 2090 mcg/kg of milk, most in the range of 100 to 500 mcg/kg of milk. Samples with negative odor tests contained concentrations in the range of 0.98 to about 20.23 mcg/kg of milk. In one woman who donated 3 samples, the highest concentration of 71 mcg/kg occurred at 1.5 hours after ingestion, with concentrations of 1 mcg/kg before ingestion and 15 mcg/kg at 9.5 hours after ingestion.[18] Eight women had their milk analyzed for 1,8-cineole metabolites. Ten metabolites and several enantiomers of these metabolites were detected.[19][20]
Five women who were nursing infants between 6 and 55 weeks of age drank 950 mL of fennel-anise-caraway tea (Messmer Ostfriesische Tee Gesellschaft Laurens Spethmann GmbH & Co. KG, Seevetal, Germany). The main odorant components of the tea are the following terpenes: limonene, 1,8-cineole, fenchone, estragole, carvone, trans-anethole, p-anisaldehyde and anisketone. Mothers collected milk samples at 30 minutes, 1 and 2 hours after ingesting the tea. Ingestion of the tea did not increase the overall terpene content of the milk, but there was wide variation from mother to mother. Some mothers had high background levels of some terpenes, probably from other foods or person care products. In addition, a sensory panel found no significant change in the odor profile of the breastmilk samples compared to blank samples.[21]
Infant Levels. Relevant published information was not found as of the revision date.
Possible effects on lactation
A group of 5 nursing mothers were given no herb for 5 days, 15 mL of a 5 % infusion of fennel seeds 3 times daily for 10 days, followed by another 5-day control period from days 15 to 20. Their diet and environment were kept constant during the study period. Milk volume was measured daily and milk fat percentage was measured on days 5, 10, 15 and 20. Milk volume and fat content increased somewhat during the 10-day treatment period and carried over for 3 to 5 days after discontinuation.[23] Because of the lack of randomization, blinding and controls, and small number of participants, no valid conclusion can be made from this study on the galactogogue effects of fennel.
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, fenugreek 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, including fennel, no single ingredient can be considered solely responsible for the tea’s effects, although the authors attributed the action to fengreek[24]
An herbal tea containing fennel, fenugreek, hibiscus, 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 after 7 to 10 days. No difference was found in the markers between mothers who received the tea and the water.[25]
An uncontrolled, nonrandomized, nonblinded study in Iran enrolled 46 healthy nursing mothers between 18 and 35 years of age. At the start of the study, mothers were all nursing their infants and having no difficulty in doing so. The mothers’ serum prolactin was measured in the morning before breakfast at least one hour after the previous nursing bout. Prolactin was measured before and after receiving powdered fennel in a dose of 3 grams daily by mouth for 15 days. The average baseline serum prolactin concentration was 64.6 mcg/L. The serum prolactin concentration after fennel therapy was 95.6 mcg/L. The difference was statistically significant. No measurements of milk production were made.[26]
The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
References
1. Yarnell E . Botanical medicine in pregnancy and lactation. Altern Complement Ther. 1997;3 (April):93-100.
2. Ayers JF. The use of alternative therapies in the support of breastfeeding. J Hum Lact. 2000;16:52-6. PMID: 11138225
3. Dennehy C, Tsourounis C, Bui L, King TL. The use of herbs by California midwives. J Obstet Gynecol Neonatal Nurs. 2010;39:684-93. PMID: 21044150
4. Hardy ML. Women’s health series: herbs of special interest to women. J Am Pharm Assoc (Wash). 2000;40:234-42 . PMID: 10730024
5. Petrie KA, Peck MR. Alternative medicine in maternity care. Prim Care. 2000;27:117-36. PMID: 10739460
6. Westfall RE. Galactagogue herbs: a qualitative study and review. Can J Midwifery Res Practice. 2003;2:22-7.
7. Sayed NZ, Deo R, Mukundan U. Herbal remedies used by Warlis of Dahanu to induce lactation in nursing mothers. Indian J Tradit Knowl. 2007;6:602-5.
8. Jackson PC. Complementary and alternative methods of increasing breast milk supply for lactating mothers of infants in the NICU. Neonatal Netw. 2010;29:225-30. PMID: 20630837
9. Abascal K, Yarnell E. Botanical galactagogues. Altern Complement Ther. 2008;14:288-94.
10. Alachkar A, Jaddouh A, Elsheikh MS et al. Traditional medicine in Syria: folk medicine in Aleppo governorate. Nat Prod Commun. 2011;6:79-84. PMID: 21366051
11. Winterfeld U, Meyer Y, Panchaud A, Einarson A. Management of deficient lactation in Switzerland and Canada: A survey of midwives’ current practices. Breastfeed Med. 2012;7:317-8. PMID: 22224508
12. The Academy of Breastfeeding Medicine Protocol Committee. ABM clinical protocol #9: use of galactogogues in initiating or augmenting the rate of maternal milk secretion (First revision January 2011). Breastfeed Med. 2011;6:41-9. PMID: 21332371
13. Stapleton H. The use of herbal medicine in pregnancy and labour. Part II: Events after birth, including those affecting the health of babies. Complement Ther Nurs Midwifery. 1995;1:165-7. PMID: 9456733
14. Hausner H, Bredie WL, Molgaard C et al. Differential transfer of dietary flavour compounds into human breast milk. Physiol Behav. 2008;95:118-24. PMID: 18571209
15. Weizman Z, Alkrinawi S, Goldfarb D, Bitran C. Efficacy of herbal tea preparation in infantile colic. J Pediatr. 1993;122:650-2. PMID: 8463920
16. Alexandrovich I, Rakovitskaya O, Kolmo E et al. The effect of fennel (Foeniculum vulgare) seed oil emulsion in infantile colic: a randomized, placebo-controlled study. Altern Ther Health Med. 2003;9:58-61. PMID: 12868253
17. Savino F, Cresi F, Castagno E, Silvestro L, Oggero R. A randomized double-blind placebo-controlled trial of a standardized extract of Matricariae recutita, Foeniculum vulgare and Melissa officinalis (ColiMil) in the treatment of breastfed colicky infants. Phytother Res. 2005;19:335-40. PMID: 16041731
18. Kirsch F, Beauchamp J, Buettner A. Time-dependent aroma changes in breast milk after oral intake of a pharmacological preparation containing 1,8-cineole. Clin Nutr. 2012;31:682-92. PMID: 22405404
19. Kirsch F, Buettner A. Characterisation of the metabolites of 1,8-cineole transferred into human milk: Concentrations and ratio of enantiomers. Metabolites. 2013;3:47-71.
20. Kirsch F, Horst K, Rohrig W et al. Tracing metabolite profiles in human milk: studies on the odorant 1,8-cineole transferred into breast milk after oral intake. Metabolomics. 2013;9:483-96.
21. Denzer M, Kirsch F, Buettner A. Are odorant constituents of herbal tea transferred into human milk? J Agric Food Chem. 2015;63:104-11. PMID: 25436940
22. Rosti L, Nardini A, Bettinelli ME, Rosti D. Toxic effects of a herbal tea mixture in two newborns. Acta Paediatr. 1994;83:683. Letter. PMID: 7919774
23. Nikolov P, Avramov NR. [Investigations on the effect of Foeniculum vulgare, Carum carvi, Anisum vulgare, Crataegus oxyacanthus, and Galga officinalis on lactation]. Izv Meditsinskite Inst Bulg Akad Naukite Sofia Otd Biol Meditsinski Nauki. 1951 ;1:169-82. PMID: 14888359
24. Turkyilmaz C, Onal E, Hirfanoglu IM et al. The effect of galactagogue herbal tea on breast milk production and short-term catch-up of birth weight in the first week of life. J Altern Complement Med. 2011;17:139-42. PMID: 21261516
25. Kavurt S, Bas AY, Yucel H et al. The effect of galactagogue herbal tea on oxidant and anti-oxidant status of human milk. J Matern Fetal Neonatal Med. 2013;26:1048-51. PMID: 23363373
26. Honarvar F, Tadayon M, Afshari P et al. The effect of foeniculum vulgare on serum prolactin level in lactating women. Iran J Obstet Gynecol Infertil. 2013;16:18-24.
Last Revision Date
20150310
Disclaimer:Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
Source: LactMed – National Library of Medicine (NLM)