Medicines Q&As Q&A 93.3 Is it safe for breastfeeding women to take herbal medicines? Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals Before using this Q&A, read the disclaimer at www.ukmi.nhs.uk/activities/medicinesQAs/default.asp Date prepared: 29th March 2012 Background A comparison of two national surveys in the United States showed that between 1997 and 2002, herbal medicines use rose by over 50% (1). In the United States, women between 30 and 50 years old are the most likely users of complementary health care products (2). A trend in herbal medicine use similar to that in the United States has been observed in the United Kingdom. It is likely therefore that many women are using herbal medicines during lactation, probably for reasons such as postpartum depression, to increase/decrease milk supply and to relieve physical discomfort associated with breastfeeding. The exact extent of herbal medicine use by women in the United Kingdom during lactation is unknown. However, a survey conducted among 600 Norwegian women found that of the women who had previously breastfed a child, 37.3% had used herbal medicines to increase milk production (3). Answer Scientific information on the safety of herbal medicines during lactation is scarce and a literature search revealed no rigorous trials in this area. Whether or not many herbal medicines pass into breast milk is unknown. Furthermore, contamination of herbal medicines with substances such as conventional medicines, pesticides and heavy metals cannot be ruled out. In view of the lack of safety data, it is generally advised that breastfeeding mothers avoid taking herbal medicines (4,5). There is a scarcity of reports in the literature concerning breastfed infants who have experienced adverse effects associated with herbs ingested by their mothers, but the assumption must not be made that herbal medicines are unlikely to cause problems in breastfed infants. One published report suggested that a soup made of dong quai was the cause of hypertension in a mother and her threeweek-old baby. The baby’s blood pressure returned to normal when breastfeeding was discontinued for a couple of days (6). Another report has been found of an exclusively breastfed 9 day old term male infant who presented with a one day history of lethargy, decreased milk intake, anaemia and jaundice (7). The lactating mother, who was asymptomatic, had started drinking tea made from arnica flowers 48 hours before the onset of symptoms. Exchange transfusions were used to lower the infant’s bilirubin and correct the anaemia. The mother stopped drinking the tea and resumed breastfeeding, and no further haemolysis or other problems were noted in the infant (7). A few herbs have the potential to harm infants exposed to them via breast milk. Among these are herbs containing pyrrolizidine alkaloids (PAs), some of which can be hepatotoxic if taken orally (8). Some herbal teas may also contain PAs; exact ingredients are not always listed on the herbal tea and it has been advised that lactating mothers limit their exposure to herbal teas and avoid those of unknown composition (9). Some sources advise against the use of herbs containing anthranoids (other than senna) (8,10). Anthranoids have laxative effects and are partially excreted into breast milk (8). Examples of herbs that are contraindicated in breastfeeding are provided below, this list is not exhaustive: Aloe (oral), buckthorn berry and bark, blue cohosh, cascara sagrada bark, coltsfoot, comfrey, germander, gordolobo yerba tea, Indian snakeroot, jin bu huan, kava kava, margosa oil, mate tea, mistletoe, pennyroyal oil, Petasites root, rhubarb root, sage, skullcap and uva ursi (11). Available through NICE Evidence Search at www.evidence.nhs.uk 1 Medicines Q&As Examples of herbal medicines that might be selected by breastfeeding women are given below with a brief discussion of the safety concerns associated with them: Herbs for physical discomfort related to breastfeeding Comfrey is a PA-containing herb sometimes used by breastfeeding mothers on their nipples to prevent dry, cracked skin. According to one US source, it has been associated with hepatic venoocclusive disease in infants and should be avoided (12). A further source advises against the use of comfrey and members of this Boraginacae family in breastfeeding mothers when administered topically, orally or in any form (9). One report has been published of a 17-day-old infant with a generalised urticaria whose mother had applied water boiled with stinging nettle onto her nipples twice a day (before and after each breastfeed) for two days in order to heal her nipple cracks. Serum total immunoglobulin E (IgE) and specific IgE levels for stinging nettle were high in both the infant and the mother. The rashes disappeared completely by the second day without treatment. A skin prick test with the water boiled with stinging nettle was positive for the infant with significant induration, but not for the mother (13). In any case of topical treatment, washing the breast after the application and before breastfeeding is recommended (14). Herbs to increase milk production Herbal medicines reported to be commonly used as galactagogues, i.e. to increase milk production include alfalfa, anise, blessed thistle, fenugreek and fennel (15,16). Other well-known galactagogues are milk thistle, chasteberry (8), goat’s rue, shatavari (asparagus racemosus), caraway seed, dill and borage (17). Borage may contains PAs (18) and should be avoided by breastfeeding mothers. An uncontrolled study found that ten women who used breast pumps to express milk noted a statistically significant increase in breast milk production (p=0.004) when they took three capsules of fenugreek seed three times a day. No side effects were reported in their infants, but the published information on the study is too brief to determine whether study participants were questioned about side effects (19). A small study assessed mothers who received at least 3 cups of herbal tea containing fenugreek (n=22) daily against placebo apple tea (n=22) and a control group (n=20) who were not advised any special recommendations. Infants in the fenugreek tea group regained their birth weight earlier than those in the control and placebo groups (6.7 ± 3.2 days in the fenugreek group versus 7.3 ± 2.7 days in the placebo group versus 9.9 ± 3.5 days in the control group, p<0.05). The mean measured breast milk volume of the mothers who received fenugreek tea was significantly higher than the placebo or control groups (73.2 ± 53.5mL in fenugreek group versus 38.8 ± 16.3mL in the placebo group versus 31.1 ± 12.9mL in the control group, p<0.05) (20). However a case has been reported in which gastrointestinal bleeding occurred in a premature (30 weeks) baby, whose mother had received fenugreek (11). Though the proportion of a fenugreek dose that passes into human milk is unknown, passage does occur and the infant’s urine may smell like maple syrup, as with Maple Syrup Urine Disease (21). The mother may also experience a maple-like smell of urine, breast milk and perspiration (22). Colic, abdominal discomfort and diarrhoea have been reported in babies whose mothers took fenugreek (23). The nursing mother should avoid taking fenugreek if they have a history of asthma, allergic reactions or diabetes or take antihypertensives, anticoagulants or antiplatelets (23,24). Blessed thistle, though reported to have low toxicity, can cause hypersensitivity reactions and has laxative properties. It is not known whether blessed thistle passes into breast milk (21). Any herbs that might have hormonal effects, e.g. chasteberry (also known as agnus castus) should be avoided during lactation. Chasteberry is used to relieve symptoms of mastalgia, its hormonal activity however can inhibit prolactin secretion and thus suppress milk production (21). Similarly, alfalfa (25) and fennel are not recommended during breastfeeding because they might have oestrogenic properties, which could actually inhibit breast milk production (11). Neurotoxicity (hypotonia, lethargy, emesis, weak cry and poor sucking) has been reported in two breastfed infants whose mothers drank an herbal tea that included fennel, liquorice, goat's rue and anise (26). It has also been advised that caraway oil, which is extracted from the seeds, is avoided by breastfeeding mothers (27). Available through NICE Evidence Search at www.evidence.nhs.uk 2 Medicines Q&As Milk thistle contains flavolignans, which may act on oestrogen receptors (ER2) by limiting the endogenous receptors' antagonism of milk production (22). A small, non-randomised, unblinded study compared 25 women who received micronised milk thistle (420mg daily) for 63 days against 25 placebo-controlled women. The authors reported an 86% increase in daily milk production in the treated group versus 32% increase in the placebo group (28). However limited information was available regarding the infants and their mothers (28). Possible adverse effects of milk thistle include allergic reactions and mild laxative effects (8). The effects of asparagus (asparagus racemosus) on lactation have been investigated in three clinical studies (29-31). In the first, a randomised, placebo-controlled study involving 64 mothers (n=32 in each group) who had reported lactational deficiency, a galactagogue containing asparagus racemosus as the ‘active ingredient’ did not increase milk production or prolactin hormone levels. No significant side effects were reported in this study (29). In the second, non-blinded study, a definite increase in milk production was reported by 11 of the 15 women involved (29,30). In contrast to the first study, a double-blind, randomised, placebo-controlled, parallel group study involving 60 lactating mothers (n=30 in each group) showed an increase in mean prolactin hormone level three times higher in the mothers in the research group than those in the control group (32.87 ± 6.48 versus 9.56 ± 4.57, p<0.05). The average percentage increase in the weight of babies was 16.13 ± 3.65 versus 5.68 ± 2.57 in the control group (p<0.05) (31). A small study in 82 women indicated that the use of the traditional Japanese herbal medicine Xionggui-tiao-xue-yin (an extract of 13 herbs) in the postpartum period stimulates lactation. The herbal medicine treated group (n=41) had higher plasma prolactin concentrations on days 1 and 6 postpartum compared to the group treated with ergometrine 0.375mg/day (n=41). The herbal group also produced statistically significantly greater quantities of milk (measured by baby weight) on days 4 to 6 compared to the ergometrine group. Although no adverse effects were reported in the mothers, no data was provided on the wellbeing of the infants (32). Overall, there is not enough available information to support the use of fenugreek, anise, chasteberry, alfalfa, fennel, borage, blessed thistle, milk thistle, goat’s rue, dill, caraway or asparagus in nursing mothers (18,22,25,27,29,33-40). The use of galactogogues (mainly non-herbal) has been recently reviewed in the UKMi Q&A ‘Drug treatment of inadequate lactation’ (41). Herbs which decrease milk supply Sage is thought to reduce a lactating mother's milk supply (42). Some recommend using it during the process of weaning (14,43). Other herbs reported to decrease milk supply include peppermint, spearmint, parsley, chickweed, black walnut, stinging nettles, yarrow, Herb Robert, lemon balm, oregano, periwinkle herb, and sorrel (14,43). St John’s Wort for post-natal depression The management of depression with complementary medicines has recently been reviewed in an UKMi Q&A ‘Management of depression in breastfeeding mothers – are St John’s Wort and other complementary therapies safe?’ (44). Although there is some evidence that St John’s Wort may be of benefit in treating mild to moderate depression, NICE advises that it should not be prescribed or recommended for use by patients because of uncertainty about appropriate doses, variation in the nature of preparations and potential serious interactions with other medicines (45,46). Some evidence exists for the safety of St John’s Wort during breastfeeding, but further investigation is required (47,48). For the time being, it is recommended that women do not self medicate with St John’s Wort (45). Infants exposed to St John’s Wort during breastfeeding should be monitored for adverse effects, particularly sedation and poor feeding. Prematurity or illness would set infants at greater risk of adverse effects from exposure to St John’s Wort and its use in mothers who are breastfeeding such infants should be avoided (44). Available through NICE Evidence Search at www.evidence.nhs.uk 3 Medicines Q&As Other commonly used herbs Black cohosh: Caution is recommended. Black cohosh could have oestrogenic and/or antioestrogenic activity (49). Theoretically therefore black cohosh might negatively affect breast milk production due to its oestrogenic effects (11). Coenzyme Q10: It is likely that coenzyme Q10 passes into breast milk (11). Because of the lack of safety data, it is recommended that coenzyme Q10 is avoided by breastfeeding mothers (11). Echinacea: Tinctures of echinacea can contain high amounts of alcohol which would be contraindicated in nursing mothers (21). Although it is generally well tolerated, allergic reactions are possible with echinacea (21). It is not known whether echinacea transfers into breast milk or affects lactation (11). Echinacea should be used with caution until there is further evidence to support its safety (50). Garlic: Passage of garlic into breast milk may affect the smell and taste of breast milk and, ideally, large amounts should be avoided. There are anecdotal reports of colic in infants following exposure to garlic through breast milk (21). Ginkgo biloba: There is nothing in the evidence-based medical literature to suggest that ginkgo leaf is safe or unsafe during breastfeeding. Medicinal use of raw ginkgo seeds might not be safe during lactation, according to a toxicology compendium (51). Known adverse effects include gastrointestinal upset, headache, dizziness, constipation, and of more concern are reports of spontaneous bleeding (52). Until further information becomes available, use of ginkgo during breastfeeding is probably best avoided. Ginseng (Panax): It is not known whether ginseng passes into breast milk, but caution is recommended (11). There is conflicting information as to whether ginseng has oestrogenic effects (53,54). Oestrogens are known to suppress breast milk production. Valerian: Tinctures of valerian may contain high amounts of alcohol which would be contraindicated in nursing mothers (21). No data on excretion into breast milk are available (11). Side effects include headache, gastric discomfort, morning drowsiness, insomnia, cardiac disturbances and vivid dreams (55). Herbs with sedative constituents are usually avoided in nursing infants due to the potential risks of lethargy and poor weight gain in the infant and concerns over potential risks of sudden infant death syndrome (21). Practical Information Although it is not currently recommended, if a breastfeeding woman does decide to take an herbal medicine, it should be with the knowledge of a healthcare professional (e.g. health visitor, doctor or pharmacist) and the product should come from a reputable source. It is also important to take into consideration why a woman wishes to take an herbal medicine as undiagnosed illness that remains untreated by conventional methods might result in harm to the individual. As for conventional medicines taken during breastfeeding, the risk of adverse events is greater in premature or very young infants and in those with a concurrent illness. Summary It is generally advised that breastfeeding mothers avoid herbal medicines. This is due to the lack of information on whether or not various herbal medicines pass into breast milk, and of scientific safety data. Furthermore, contamination of herbal products with conventional medicines, pesticides or heavy metals cannot be ruled out. Herbs containing pyrrolizidine alkaloids (PAs) can be hepatotoxic and are therefore potentially harmful to any infants exposed to them via breast milk. Available through NICE Evidence Search at www.evidence.nhs.uk 4 Medicines Q&As Some sources advise against the use of plants containing anthranoids, which have laxative effects. Other herbal medicines have hormonal effects which would render them unsuitable for breastfeeding women. Herbal medicines that contain constituents with sedative properties should be avoided due to the potential adverse effects in the infant. Although there is some evidence that St John’s Wort may be of benefit in treating mild to moderate depression, NICE advises that it should not be prescribed or recommended for use by patients because of uncertainty about appropriate doses, variation in the nature of preparations and potential serious interactions with other medicines. Some evidence exists for the safety of St John’s Wort during breastfeeding, but further investigation is required. For the time being, it is recommended that women do not self medicate with St John’s Wort. Infants exposed to St John’s Wort during breastfeeding should be monitored for adverse effects, particularly sedation and poor feeding. If an herbal medicine is taken during breastfeeding, it should be with the knowledge of a healthcare professional (e.g. health visitor, GP, pharmacist) and the products should come from a reputable source. Healthcare professionals should take into consideration why a woman wishes to take an herbal medicine. Undiagnosed illness that remains untreated by conventional methods might result in harm to the individual. The risk of adverse events in a breastfed infant is higher for premature or very young infants and in those with a concurrent illness. Limitations There is a lack of published scientific information on the safety of herbal medicines in breast fed infants and on whether or not various herbal medicines pass into breast milk. The list of herbal medicines included in this review is not exhaustive, absence from this Q&A does not imply that an herbal medicine is safe to use in breastfeeding. References (1) Tindle HA, Davis RB, Phillips RS et al. Trends in use of complementary and alternative medicine by US adults: 1997-2002. Altern Ther Health Med. 2005;11:42-9. (2) Ritchie HE. The safety of herbal medicine: use during pregnancy. Frontiers in Fetal Health. 2001;3:259-66. In: Conover EA. Herbal agents and over-the-counter medications in pregnancy. 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Available from: http://naturaldatabase.therapeuticresearch.com/home.aspx?cs=&s=ND [cited 3/3/12]. Quality Assurance Prepared by Anna Burgess, Welsh Medicines Information Centre, University Hospital of Wales (based on earlier work by Alex Bailey) Date Prepared 29th March 2012 Checked by Gail Woodland, Welsh Medicines Information Centre, University Hospital of Wales Date of check 30th March 2012 Acknowledgements We would like to thank Peter Golightly (Director, Trent Medicines Information Service) for his helpful comments. Search strategy Embase ([herbal medicine OR exp medicinal plant] AND [breast milk OR lactation OR breast feeding] Limit year: 2009 to current) Medline ([exp plants, medicinal OR exp drugs, Chinese herbal OR phytotherapy OR exp herbal medicine] AND [milk, human OR exp lactation OR exp breast feeding] Limit year: 2009 to current) NeLM (“herbal medicines” AND breast) IDIS (herbal medicines 92510000 OR Chinese herbal medicines 92510129 AND lactating mother v24.1 OR PKIN excretion milk 24. Limit year: 2009-2012) AltMedex (lactation) (herbal medicine name) Natural Medicines Comprehensive Database (herbal medicine name) Herbal medicines online (herbal medicine name) United Kingdom Drugs in Lactation Advisory Service (UKDILAS), Trent and West Midlands Medicines Information Service. Available through NICE Evidence Search at www.evidence.nhs.uk 8