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Cannabis and Breastfeeding
Cannabis use on a regular basis by breastfeeding mothers concerns me. Cannabis has a long half life (25-57 hours) and it takes 5 times this to be removed from milk. THC crosses the blood brain barrier and it is known to accumulate in body fats. Although it is highly protein bound and subject to first pass metabolism, the milk plasma ratio is 8. We do not know enough about the impact on the developing brain to be sure that the amount passing through breastmilk is safe. Regular use is not recommended in the breastfeeding mother or other members of the family who may expose the baby through passive inhalation.
Breastfeeding and Cannabis factsheet
see also Cannabis and Breastfeeding: What We Know and What We Should Do – LCGB
Osteoporosis and breastfeeding
Following on from the data on the menopause and breastfeeding, I know many women are advised to limit the duration of breastfeeding in order to protect their own bone density. This sadly often shows a mis understanding of breastfeeding and its importance to the ongoing health of mother and child.
I hope this information taken from Breastfeeding and Chronic Medical Conditions helps
Osteoporosis and breastfeeding fact sheet
” I have severe early onset osteoporosis causing 12 spinal compression fractures. The challenges were
managing my pain relief, deciding on a medication that could treat my low bone density whilst
breastfeeding…. but also positioning and attachment with a spine that is inflexible and incredibly
painful. Just lifting my new-born caused some fracturing. We nailed the pain relief and medication
for osteoporosis side of things and with help positioning side of things. I was an experienced breast
feeder but had never fed whilst so immobile and in pain before. Thankfully I am still feeding him now,
over 4 years later. I am not cured; I never will be as it is a degenerative disease. I continue to suffer
fractures. But looking back the help I had to enable me to breastfeed was the only way I was able to
independently care for my new baby. I was bed bound and could never have managed formula
preparation. Now that I too am in the shield group, I am thankful that I am still breastfeeding to help
boost his immune system in this most terrifying time.“
Description
Osteoporosis is a condition that weakens bones, making them fragile and more likely to fracture. It
develops slowly over several years and is often only diagnosed when a fall or sudden impact causes a
bone to break. Osteoporosis affects over 3 million people in the UK. It is frequently diagnosed in
women after the menopause but not exclusively.
Other risk factors for osteoporosis:
- taking high-dose steroid tablets for more than 3 months
- other medical conditions – such as inflammatory conditions, hormone-related conditions, or
malabsorption problems - a family history of osteoporosis – particularly a hip fracture in a parent
- long-term use of certain medicines that can affect bone strength or hormone levels, such as
anti-oestrogen tablets that many women take after breast cancer having or having had an eating disorder such as anorexia or bulimia - having a low body mass index (BMI)
- not exercising regularly
- heavy drinking and smoking
It can be prevented by taking regular, weight bearing exercise, eating a diet rich in calcium and
vitamin D (or taking supplements), abstaining from smoking and high alcohol use.
Treatment - Calcium and vitamin D supplements: minimum 10 micrograms vit d and 700mg -1200mg
calcium - Bisphosphonates: bisphosphonates should always be taken on an empty stomach with a full
glass of water, standing or sitting upright for 30 minutes after taking them. Other drinks or
foods should be avoided for 30 minutes and 2 hours.
Alendronic acid (Alendronate ™) https://www.ncbi.nlm.nih.gov/books/NBK501621/
Ibandronic acid (Bonviva ™) https://www.ncbi.nlm.nih.gov/books/NBK501616/
Risedronic acid (Actonel™) – no information on levels in breastmilk but poor oral
bioavailability
Zoledronic acid – no information on levels in breastmilk but poor oral bioavailability
Raloxifene – no information and may suppress lactation - Denosumab: an alternative for women with osteoporosis who have been through the
menopause if a bisphosphonate is not suitable or is not tolerated. It is given twice a year by
injection and helps to slow down bone loss. As with bisphosphonates, there is a small risk of
a rare problem of the jawbone, called osteonecrosis - Breastfeeding and Bone Density Research
The effects of breastfeeding on mothers’ bone health (UNICEF Baby Friendly Hospital Initiative
https://www.unicef.org.uk/babyfriendly/news-and-research/baby-friendly-research/maternalhealth-research/maternal-health-research-bone-density/ - Caroline J. Chantry et al (2004). Lactation Among Adolescent Mothers and Subsequent Bone
Mineral Density. Arch Pediatr Adolesc Med. 158:650-656 - Paton LM et al (2003). Pregnancy and lactation have no long-term deleterious effect on
measures of bone mineral in healthy women: a twin study. Am J Clin Nut 77: 707-14 - Kalkwarf HJ, Specker BL (1995) Bone mineral loss during lactation and recovery after
weaning. Obstet Gynecol 86: 26-32
Kalkwarf HJ (1999) Hormonal and dietary regulation of changes in bone density during
lactation and after weaning in women. J Mammary Gland Biol Neoplasia 4: 319-29
Further information on Osteoporosis
Royal Osteoporosis Society https://theros.org.uk
please email me wendy@breastfeeding-and-medication.co.uk if you need more information
Ustekinumab (Stelara ™) and Breastfeeding
Ustekinumab is a disease modifying, biological drug used to treat psoriatic arthritis, plaque psoriasis, Crohns disease, and ulcerative colitis. It is given by sub cutaneous injection.
It has a molecular weight 149,000, poor oral bioavailability and milk plasma ratio 0.001 – 0.027
Ustekinumab is a recombinant human monoclonal TNF antibody that binds specifically to TNF- α.
It is likely that any small amounts in milk are destroyed in the baby’s gut. Three studies have shown very low levels in milk but the babies showed no evidence of increased rates of infection or other effects on physical or mental health.
BNF states that “specialist sources indicate use with caution; negligible amounts present in milk which are likely to be destroyed in the infant’s gastro-intestinal tract. In newborn or premature infants there may be greater intestinal absorption. “
Ustekinumab is compatible with breastfeeding due to poor bio-availability and hence low-level absorption by the infant. It should be avoided in the first few days post partum when the gaps between the cells are wide open to facilitate transfer of immunoglobulins.
If it is used in pregnancy live vaccines should be avoided in the baby – normally rotavirus because immunity may be compromised. If not used in pregnancy when the rotavirus is given, the breastfeeding mother needs to wear gloves for 2 weeks to avoid picking up the live viral fragments shed in faeces. This alert card may be useful to have within the red book to remind professionals.
References
- Klenske E, Osaba L, Nagore D, Rath T, Neurath MF, Atreya R. Drug Levels in the Maternal Serum, Cord Blood and Breast Milk of a Ustekinumab-Treated Patient with Crohn’s Disease. J Crohns Colitis. 2019;13(2):267-269.
- Saito J, Kaneko K, Kawasaki H, et al. Ustekinumab during pregnancy and lactation: drug levels in maternal serum, cord blood, breast milk, and infant serum. J Pharm Health Care Sci. 2022;8(1):18.
- Bar-Gil Shitrit A, Ben-Horin S, Mishael T, et al. Detection of Ustekinumab in Breast Milk of Nursing Mothers With Crohn Disease. Inflamm Bowel Dis. 2021;27(5):742-745
- https://www.ncbi.nlm.nih.gov/books/NBK500594
- https://e-lactancia.org/breastfeeding/ustekinumab/product/
Adalimumab (Humira™) and Breastfeeding
Adalimumab is a disease modifying, biological drug used to treat rheumatoid arthritis, psoriatic arthritis, Crohns disease, ulcerative colitis and Hidradenitis suppurativa. It is given by sub cutaneous injection.
It has a molecular weight 148,000. Poor oral bioavailability and relative infant dose 0.12% ( well below 10% regarded as compatible).
Adalimumab is a recombinant human monoclonal TNF antibody that binds specifically to TNF- α.
It is likely that any small amounts in milk are destroyed in the baby’s gut. Two infants of women who
took adalimumab 40 mg subcutaneously during lactation were followed until 14.5 and 15 months of
age. No adverse reactions were found in the infant to be attributed to exposure of the drug in breast
milk. Both infants were reported to have met all developmental milestones (Fritzsche 2012).
BNF however states that it should be avoided by breastfeeding mothers because the manufacturer
advises it should be avoided for at least 5 months after last dose. This is not based on evidence.
Adalimumab is compatible with breastfeeding due to poor bio-availability and hence low-level absorption by the infant. It should be avoided in the first few days post partum when the gaps between the cells are wide open to facilitate transfer of immunoglobulins.
If it is used in pregnancy live vaccines should be avoided in the baby – normally rotavirus because immunity may be compromised. If not used in pregnancy when the rotavirus is given, the breastfeeding mother needs to wear gloves for 2 weeks to avoid picking up the live viral fragments shed in faeces. This alert card may be useful to have within the red book to remind professionals.
References
- Wasan SK, Kane SV. Adalimumab for the treatment of inflammatory bowel disease. Expert
- Rev Gastroenterol Hepatol. 2011 Dec;5(6):679-84.
- Fritzsche J, Pilch A, Mury D, Schaefer C, Weber-Schoendorfer C. Infliximab and adalimumab
- use during breastfeeding. J Clin Gastroenterol 2012;46(8):718-19.
- https://www.ncbi.nlm.nih.gov/books/NBK501392/
- https://e-lactancia.org/breastfeeding/adalimumab/product/
Raised cholesterol and breastfeeding
When I was working as an independent pharmacist prescriber my main role was to look at primary prevention of cardio vascular disease – identifying factors which raised the risk of people to have a heart attack or stroke in the next 10 years. I used an online calculator using various data like BMI, smoking status, blood pressure and cholesterol ( https://qrisk.org/three/). I didnt see many breastfeeding patients and we concentrated on the over 50s. But in the process I learned a lot about managing weight and encouraging a healthy diet and portion size, smoking cessation and control of cholesterol. In many cases we managed to reduce the risk with lifetyle changes.
It seems that mothers may now have their cholesterol measure and advised that it is too high. I had 20 -30 minute appoitments to encourage lifestyle change. This isnt possible for GPs with pressures on appointments so often the mothers are offered medication to reduce cholesterol. Until recently the only drug compatible with breastfeeding was cholestryamine. This is fine if there isnt a history of familial hypercholesterolaemia and a much higher risk of a cardio vascular event.
A colleague pointed me to some data on elactancia which had a very different list of references and information on cholesterol in standard artificial formula. Thus began a journey to this factsheet over the past couple of months. It isnt a recommendation, as there are currently no studies on the use of statins during breastfeeding nor the effect on the baby . However, it looks at an evidence base which can prompt discussion with clinicians. I hope it helps.
My thanks to Sam Morris and Amanda Da Costa for their knowledge and support as pharmacists and breastfeeding helpers on the BfN Drugs in Breastmilk Information Service
UPDATE
In a 2024 study Campbell et al studied milk samples from 3 women who had taken atorvastatin at various doses. The highest weight-adjusted relative infant dose of the combined analytes was 0.09%, far below established thresholds for infant safety (10%). Milk cholesterol levels were within previously established norms in the range of 10 mg/dL. The mothers reported no adverse outcomes in the two exposed infants. The authors concluded that “it is unlikely that the drug in the milk would be present in clinically significant levels to adversely affect a breastfed infant.”
Campbell L, Huseman K, Krutsch K, Datta P. Minimal Transfer of Atorvastatin and Its Metabolites in Human Milk: A Case Series. Breastfeed Med. 2024 Sep 13. doi: 10.1089/bfm.2024.0258. Epub ahead of print. PMID: 39268678.
Raised cholesterol and breastfeeding factsheet
- If a breastfeeding mother has raised cholesterol (not familial) encourage diet and lifestyle changes and monitor at intervals
- If the breastfeeding mother has familial hypercholesteraemia it is likely that the baby has been born with high cholesterol and it is assumed that even reducing the level in maternal milk will still exceed that in standard infant formula together with added protective cardio-vascular properties of breastmilk (Holmsen)
- Standard Infant formula contains no cholesterol (Lawrence) but also lacks the cardio protective properties of breastmilk (Tschiderer)
- Breastfeeding has many factors to protect the mother and baby from future cardiovascular disease
NB This data has been taken from expert sources but there is currently an absence of data and research studies on the effect of statins on breastfed babies.
This document provides an overview of research and is not intended as a recommendation. Treatment of raised cholesterol in breastfeeding should be made after informed discussion between parents and their professionals whilst protecting breastfeeding.
Cholesterol
Cholesterol is necessary for the development of brain tissue, myelination of nerves, and is the basis for many enzymes. Breastfed infants have higher plasma cholesterol levels than those fed standard artificial formulas as these products contain no cholesterol at all. The higher cholesterol levels in breastmilk protects babies against the consequences of hypercholesterolemia in adult life (Lawrence 2016).
Breastfeeding and Cardio-vascular disease (CVD)
Research shows that being breastfed leads to better outcomes with respect to coronary artery disease in later life (UNICEF). Cessation of breastfeeding may have consequences for the mother and baby and a recommendation to stop should not be undertaken without examining the literature for benefit and risk to the baby of the medication.
Nguyen (2019) reported that ever breastfeeding was associated with lower risk of CVD hospitalization and mortality compared with never breastfeeding, and breastfeeding ≤12 months/child was significantly associated with lower risk of CVD hospitalization. WHO (2021) and UNICEF recommend: early initiation of breastfeeding within 1 hour of birth; exclusive breastfeeding for the first 6 months of life; and. introduction of nutritionally adequate and safe complementary (solid) foods at 6 months together with continued breastfeeding up to 2 years of age or beyond.
Schwartz (2009) studied 139,681 women who had breastfed for more than 12 months across their lactations and showed a 10-15% reduction in hypertension, diabetes, hyperlipidaemia, and cardiovascular disease than those who had not breastfed.
Hui (2019) looked at an association between breastfeeding in the first three months of life with lipid profile and adiposity at around 17.5 years in a population in Hong Kong. The team found that exclusive breastfeeding, (but not mixed feeding) at 0 to 3 months, compared with formula feeding was associated with lower total cholesterol and low-density lipoprotein (LDL) cholesterol but not with high-density lipoprotein cholesterol (HDL). LDL is sometimes referred to as “bad” cholesterol because it collects in the walls of blood vessels. HDL is seen as “good” cholesterol, because it absorbs cholesterol and carries it back to the liver. The liver then flushes it from the body. High levels of HDL cholesterol can lower the risk for heart disease and stroke
Singhal (2004) studied 926 preterm babies and determines evidence for the long-term benefits of breastmilk feeding on the risk of atherosclerosis.
Owen (2002) conducted a cross-sectional study of 1,532 adolescents in 10 British towns and determined that breastfeeding is associated with increased mean serum total cholesterol and low-density lipoprotein cholesterol in infancy but with lower levels in adult life providing long-term benefits for cardiovascular health.
These studies should not be taken as the advantages of breastfeeding but rather the risk of deleterious health outcomes for babies exclusively fed with infant formula (Renfrew 2012).
Raised cholesterol
Cholesterol is a fatty substance which is made in the liver. It is also found in foods. The Mediterranean diet is generally recommended to decrease cholesterol obtained through consumption of foods.
Cholesterol levels may be found to be raised at routine monitoring of a woman. Diet and lifestyle issues should be addressed before considering the initiation of cholesterol lowering medication to avoid unnecessary medication. Raised cholesterol is mainly caused by:
- eating fatty food,
- not exercising enough,
- being overweight,
- smoking and drinking alcohol
It is recommended that those with high cholesterol eat more:
- oily fish, like mackerel and salmon
- brown rice, bread, and pasta
- nuts and seeds
- fruits and vegetables
and eat less:
- meat pies, sausages, and fatty meat
- butter, lard, and ghee
- cream and hard cheese, like cheddar
- cakes and biscuits
- food that contains coconut oil or palm oil (NHS)
They should aim to exercise more (150 minutes (2.5 hours) a week. This might include walking until the heart starts beating faster (pushing a pram round a local park or carrying baby in a sling whilst you walk possibly with a group of other mothers), swimming or cycling. However, as a new mother it is acknowledged this can be difficult. Smoking cessation can improve the levels too (for more information https://www.breastfeedingnetwork.org.uk/smoking/)
When undertaking a review of cardiovascular risk, a calculator is used to determine the likelihood of cardiovascular disease occurring in the next 10 years. Risk calculators should not be used for people already identified as being at high risk, such as those with diabetes or familial hypercholesterolaemia (see below). The risk is calculated taking into account many other factors including height, weight, age, smoking status, alcohol consumption, blood pressure, family history, chronic medical conditions, cholesterol level etc (https://qrisk.org/three/). This permits discussion with a health professional on possible lifestyle changes or initiation of medication. (See https://www.nhs.uk/conditions/nhs-health-check/your-nhs-health-check-results-and-action-plan/ for further information.
Cholestyramine may be considered as first line if medication continues to be necessary due to its low oral bioavailability (0%) so that so it cannot transfer to breastmilk, nor to the infant’s plasma via breastmilk.
Familial hypercholesterolaemia
Women with familial hypercholesterolaemia are currently advised to discontinue breastfeeding prior to beginning statin therapy after pregnancy. This is because we have little data from studies on the compatibility of statins with breastfeeding. There has always been a concern that we do not know what effect potentially lowering cholesterol in the breastfed baby has.
Familial hypercholesterolaemia (FH for short) is an inherited condition which can lead to extremely high cholesterol levels. It’s passed down through families in the genes. Without treatment, FH can lead to heart disease at a very young age. But once it’s been diagnosed, it can be treated with medicines and a healthy lifestyle (HEARTUK). As a result of their FH, the incidence of fatal or non-fatal myocardial infarction without treatment is about 50% by the age of 50 years in men and about 30% by the age of 60 years in women. (NHSEI)
The current recommendation is that statins should be discontinued three months before attempting to conceive, during pregnancy and lactation (Shala-Haskaj 2020). During this time the cholesterol level may become significantly raised even if the woman is eating a healthy, balanced diet and keeping active (NHS).
It is reported by Holmsen et al that the FELIC study showed that hypercholesterolaemia in a woman during pregnancy increased the risk of atherosclerosis in the child (Napoli 1999). They state that animal studies have shown that statin treatment in pregnant and lactating mice has a cardioprotective effect not only in the pregnant mouse but also in the offspring (Elahi 2008, 213)
Cholesterol levels are normally increased by 40% during pregnancy and lactation in healthy women (Lawrence 2016). The cholesterol in breast milk is synthesized in the mammary gland and its concentration in breast milk ranges from 27 mg/dL in colostrum to 16 mg/dL in mature breast milk (>30 days post-partum) (Lawrence 2016). Cholesterol is used in brain tissue development, myelination of nerves and as a base for many enzymes. The role of higher cholesterol in colostrum is unclear (Lawrence 2016) The amount of cholesterol in breast milk that would remain after the hypothetical reduction in cholesterol produced by statins taken by the mother, would still be much higher than that provided by standard artificial formulas (Holmsen 2017). Standard artificial formula does not vary in composition at all and lacks cholesterol itself although it contains other lipids. Lawrence comments that interest in lipids in human milk has increased after reports of advance development at 12 months (Lucas 1992), 8-10 years (Lucas 1994) and even at 18 years (Horwood 1998).
Use of statins during breastfeeding
Although there are no current studies on the use of statins in breastfeeding (Hale) in one study, breast milk from a woman with familial hypercholesterolaemia gene contained three times as much cholesterol as that of healthy control women (Tsang 1978). Holmsen et al hypothesise that if cholesterol levels are normalised by statin use, it is reasonable to assume that the lipid content of breast milk will also decrease to more normal levels but will still exceed those of standard infant formula which contains no cholesterol.
Botha et al ((Botha 2018) retrospectively reviewed 39 pregnancies from a cohort of 20 genotypically confirmed female patients with Homozygous familial hypercholesterolaemia (HoFH). Twenty-five pregnancies were exposed to lipid-lowering therapy, of which 18 were exposed to statin therapy, just prior to or during the pregnancy. The infants of HoFH patients are obligate HeFH and likely already affected by atherosclerotic lesions at birth. Twelve of the 20 patients chose to breastfeed (21 infants). “Most patients breastfed for three to six months”; three patients opted to breastfeed for nine months. However, only 6 patients (11 infants) continued breastfeeding despite restarting statin therapy after delivery, while three patients (four infants) chose not to breastfeed while on statin therapy. Botha concluded that for many females with HoFH, despite the high cardiovascular risk, pregnancy is not uncommon and that lipid lowering therapy, particularly statin therapy during pregnancy, appears to be safe for both mother and foetus. Infants had no developmental or school learning problems. Botha et al recommended “patients should discontinue all lipid lowering therapy a month prior to planned conception and reinstate lipid lowering therapy, statin plus ezetimibe, during the second trimester. This limits the possible teratogenic effect of statins during the first trimester while providing the mother with optimal care during a time of increased cholesterol production. Women’s perceptions and preferences regarding statin use in pregnancy should also be considered when giving advice in these situations. It is interesting that no recommendation is made on breastfeeding despite the health outcomes associated with infant feeding (UNICEF).
Pan (1988) studied 11 lactating women who were not breastfeeding but taking 20 mg of pravastatin orally twice daily for 2.5 days. Serum and milk samples were taken and analysed for pravastatin and its active metabolite after the fifth dose. Peak milk levels averaged 3.9 mcg/L for pravastatin and 2.1 mcg/L for its metabolite. He suggested that negligible levels were excreted into breast milk, but that benefits, and risks should be carefully considered. Using the peak levels above, a fully breastfed infant would receive a maximum of 900 ng/kg daily with this dosage or about 0.13% of the maternal weight-adjusted dosage (LactMed).
Lwin (2018) studied a mother with a 13-month child still being breastfed who was commenced on Rosuvastatin 20mg at bedtime. The peak milk concentration was 58.6 mcg/L occurred 17 hours after the dose. The authors calculated a daily infant dosage of 4.63 mcg/kg, which corresponded to a weight-adjusted 1.5% of the maternal dose. Breastfeeding was discontinued so no analysis of the baby’s plasma levels, or outcome were available.
Schutte (2018) published a case report of a woman with familial hypercholesterolemia who was started on rosuvastatin 40 mg daily on day 33 postpartum. Levels of the drug were measured up to day 80. All concentrations of the drug were in the range of 21 to 22 mcg/L. Despite the fact that samples were provided for 80 days there is no mention of the effect on the baby.
Pharmacokinetics of lipid lowering drugs
Oral bioavailability % | Plasma protein binding % | Theoretical dose | Relative infant dose | |
Simvastatin | <5% | >95 | ||
Atorvastatin | 12 to 30 | >98 | ||
Pravastatin | 17 | 50 | 0.001mg/Kg/d | 0.15% |
Rosuvastatin | 20 | 88 | 0.003 mg/Kg/d | 0.5 – 1 % |
Ezetimibe | 35 to 60 | 92-100 |
The pharmacokinetic data (high percentage of protein binding, extensive first pass metabolism and low oral bioavailability) make it highly unlikely that significant quantities of statins will pass into breast milk (Elactancia). Data taken from Lennernäs 2003, NCBI StatPerls, Krishna 2009, Elactancia, Hale)
However, lack of passage into breastmilk has not been proven in research. Standard Infant formula milk contains no cholesterol but does contain other lipids.
Statins are grouped into low, medium, and high intensity according to the percentage reduction in low-density lipoprotein cholesterol (NICE CG 181 2016):
- a 20% to 30% reduction is low intensity e.g., pravastatin
- a 31% to 40% reduction is medium intensity
- a reduction of more than 40% is high intensity e.g., simvastatin 80mg, atorvastatin >20mg, rosuvastatin > 10mg.
MHRA (2014): there is an increased risk of myopathy associated with high dose (80 mg) simvastatin.
References
- Botha TC, Pilcher GJ, Wolmarans K, Blom DJ, Raal FJ. Statins and other lipid-lowering therapy and pregnancy outcomes in homozygous familial hypercholesterolaemia: A retrospective review of 39 pregnancies. Atherosclerosis. 2018 Oct; 277:502-507. https://pubmed.ncbi.nlm.nih.gov/30270091/
- Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK501922/
- Elactancia database https://www.e-lactancia.org/breastfeeding
- Elahi 2008) MM, Cagampang FR, Anthony FW et al. Statin treatment in hypercholesterolemic pregnant mice reduces cardiovascular risk factors in their offspring. Hypertension 2008; 51: 939 – 44.
- Elahi MM, Cagampang FR, Ohri SK et al. Long-term statin administration to dams on high-fat diet protects not only them but also their offspring from cardiovascular risk. Ann Nutr Metab 2013; 62: 250 – 6.).
- Hale TW Medications and Mothers Milk – online access HalesMeds.com
- HEARTUK What is Familial hypercholesterolaemia (FH) https://www.heartuk.org.uk/cholesterol/what-is-fh
- Holmsen ST , Bakkebø T, Seferowicz M, Retterstøl K. Statins and breastfeeding in familial hypercholesterolaemia https://tidsskriftet.no/en/2017/05/commentary-and-debate/statins-and-breastfeeding-familial-hypercholesterolaemia
- Horwood LJ, Fergusson DM. Breastfeeding and later cognitive and academic outcomes. Pediatrics. 1998 Jan;101(1): E9. doi: 10.1542/peds.101.1. e9. PMID: 9417173.
- Krishna R, Garg A, Jin B, et al. Assessment of a pharmacokinetic and pharmacodynamic interaction between simvastatin and anacetrapib, a potent cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects. Br J Clin Pharmacol. 2009;67(5):520-526. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2686068/
- L.L. Hui, Man Ki Kwok, E. Anthony S. Nelson et al (2019). Breastfeeding in Infancy and Lipid Profile in Adolescence. Pediatrics, Volume 143, Issue 5.
- Lawrence RA, Lawrence RM. Breastfeeding. A guide for the medical profession. Eighth Edition. Philadelphia: Elsevier; 2016
- Lennernäs H. Clinical pharmacokinetics of atorvastatin. Clin Pharmacokinet. 2003;42(13):1141-60.
- Lucas A, Morley R, Cole TJ, Gore SM. A randomised multicentre study of human milk versus formula and later development in preterm infants. Arch Dis Child Fetal Neonatal Ed. 1994;70(2): F141-F146. doi:10.1136/fn.70.2. f141
- Lucas A, Morley R, Cole TJ, Lister G, Leeson-Payne C. Breast milk and subsequent intelligence quotient in children born preterm. Lancet. 1992 Feb 1;339(8788):261-4.
- Lwin EMP, Leggett C, Ritchie U, et al. Transfer of rosuvastatin into breast milk: Liquid chromatography-mass spectrometry methodology and clinical recommendations. Drug Des Devel Ther. 2018; 12:3645–51.
- Napoli C, Glass CK, Witztum JL et al. Influence of maternal hypercholesterolaemia during pregnancy on progression of early atherosclerotic lesions in childhood: Fate of Early Lesions in Children (FELIC) study. Lancet 1999; 354: 1234 – 41
- NCBI StatPerls Pravastatin https://www.ncbi.nlm.nih.gov/books/NBK551621/
- Nguyen, B, Gale, J, Nassar, N, et al (2019). Breastfeeding and cardiovascular disease hospitalization and mortality in parous women: evidence from a large Australian cohort study. Journal of the American Heart Association, doi.org/10.1161/JAHA.118.011056
- NHS High Cholesterol https://www.nhs.uk/conditions/high-cholesterol
- NHS Lower your cholesterol https://www.nhs.uk/live-well/healthy-body/lower-your-cholesterol/
- NHS What is high cholesterol https://www.nhs.uk/conditions/high-cholesterol
- Owen CG et al (2002). Infant Feeding and Blood Cholesterol: A Study in Adolescents and a Systematic Review.Pediatrics 110: 597-608.
- Pan H, Fleiss P, Moore L, et al. Excretion of pravastatin, an HMG CoA reductase inhibitor, in breast milk of lactating women. J Clin Pharmacol. 1988; 28:942.
- Renfrew MJ, Pokhrel S, Quigley M, McCormick F, Fox-Rushby J, Dodds R, Duffy S, Trueman P, William A. Preventing disease and saving resources: the potential contribution of increasing breastfeeding rates in the UK 2012
- Schutte AE, Symington EA, du Preez JL. Rosuvastatin is transferred into human breast milk: A case report. Am J Med. 2013;126: e7–8
- Schwarz EB Ray RM, Steube AM et al. Duration of lactation and risk factors for maternal cardiovascular disease. Obstet Gynecol 2009 May; 113:974
- Shala-Haskaj P, Krähenmann F, Schmidt D. CME: Familiäre Hypercholesterinämie – Behandlung mit Statinen in der Schwangerschaft und Stillzeit [CME: Familial Hypercholesterolemia – Statin Treatment during Pregnancy and Breastfeeding]. Praxis (Bern 1994). 2020 Apr;109(6):405-410. German
- Singhal A et al (2004). Breastmilk feeding and lipoprotein profile in adolescents born preterm: follow-up of a prospective randomised study. Lancet 363: 1571-78
- Tschiderer L, Seekircher L. , K. Kunutsor SK , Peters SAE , O’Keeffe LM, Willeit P Breastfeeding Is Associated With a Reduced Maternal Cardiovascular Risk: Systematic Review and Meta‐Analysis Involving Data From 8 Studies and 1 192 700 Parous Women. Journal of the American Heart Association 2022 https://www.ahajournals.org/doi/epub/10.1161/JAHA.121.022746
- Tsang RC, Glueck CJ, McLain C et al. Pregnancy, parturition, and lactation in familial homozygous hypercholesterolemia. Metabolism 1978; 27: 823 – 9
- UNICEF Baby Friendly Initiative: the impact that breastfeeding can have on maternal cardiovascular health. https://www.unicef.org.uk/babyfriendly/news-and-research/baby-friendly-research/maternal-health-research/maternal-health-research-heart-disease/
- WHO Infant and young child feeding June 2021 https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-feeding
The authors would like to express their gratitude to Dr James Akre and Prof Anders Hakansson for their support in the preparation of this information and to Amanda Da Costa the other pharmacists of the Breastfeeding Network Drugs in Breastmilk Information Service for their input.
Dr Wendy Jones PhD MBE, Mrs S. Morris MRPharmS
Scleratherpy and Breastfeeding
Another question not frequently asked but something I have been meaning to write for ages. Hope it helps for those who need to have this procedure.
Scleratherapy and Breastfeeding Factsheet
Sclerotherapy is a means of treating varicose veins.
Varicose veins are swollen and enlarged veins that usually occur on the legs and feet. They may be blue or dark purple, and are often lumpy, bulging or twisted in appearance. They can occur after pregnancy. Other predisposing factors are being overweight, having a job that involves a lot of standing and being female. Women seem to get the short straw in many ways.
In a healthy vein, blood flows smoothly to the heart. The blood is prevented from flowing backwards by a series of tiny valves that open and close to let blood through. If the valves weaken or are damaged, the blood can flow backwards and collect in the vein, eventually causing it to be swollen and enlarged.
Symptoms
- aching, heavy and uncomfortable legs
- swollen feet and ankles
- burning or throbbing in your legs
- muscle cramp in your legs, particularly at night
- dry, itchy and thin skin over the affected vein
If treatment is necessary, using compression stockings, taking regular exercise and elevating the affected area when resting may be recommended first line.
The most common further treatment options include:
- endothermal ablation – where heat is used to seal affected veins
- sclerotherapy – this uses special foam to close the veins
- ligation and stripping – the affected veins are surgically removed
It’s unlikely treatment on the NHS for cosmetic reasons is available but has to be sought privately.
Breastfeeding and sclerotherapy
Sclerotherapy is the procedure which seems to give rise to questions about breastfeeding. The treatment involves injecting special foam into your veins. The foam scars the veins, which seals them closed. As well as the foam the procedure involves the injection of a local anaesthetic.
The agent injected into the veins is usually Sodium Tetradecyl Sulphate. It is a modified version of sodium lauryl sulphate, a common ingredient in toothpaste, shampoo, and dish soap. Trade names include Fibro-Vein™, Sotradecol™, Trombovar™.
No data on excretion into breastmilk nor are pharmacokinetic data available, but toxicity is expected to be low. Breastfeeding can be resumed a few hours after the procedure (Hale). Like others sclerosing products used to treat varices it does not trespass into the blood stream in significative amounts nor the breast milk when applied properly. (Elactancia)
References
Elactancia https://e-lactancia.org/breastfeeding/sodium-tetradecyl-sulfate/product/
Hale TW Medications and Mother’s Milk Springer Publishers
NHS Varicose Veins https://www.nhs.uk/conditions/varicose-veins/
Thrush and Breastfeeding
I’m hearing of some really weird treatment of topical thrush in the recent few days and weeks.
- suggestion of applying miconazole oral gel to the nipples ( there are currently supply issues nationally at the moment so it is not available) which could be really dangerous and is ineffective
- applying nystatin suspension to the nipples which makes no sense at all
- a variety of creams with no evidence of effectiveness and which would necessitate washing off due to the thickness of the cream and resulting in further damage
- incorrect diagnosis of thrush which sounds much more likely to be an issue with latch which is the most important fact because it misses the opportunity to fix/reinforce the basics.
Do I believe thrush on the nipples exists? Rarely based on the experience of 25 years since I wrote the first leaflet with Magda.
What I see is :
1. Initial problems with latch
2. Latch that has slipped a little around 6 weeks
3. Pain with teething when latch changes
Please please please don’t rush in to treat but look first, second and third time at positioning and attachment particularly if there is pain during breastfeeds. A white tongue does not alone justify treatment as this may be normal or associated with less than perfect latch or tongue tie.
The BfN factsheet on thrush and breastfeeding has currently been withdrawn.
So many contacts recently about thrush and breastfeeding I have decided to record a presentation I have made many times over the years. I will in a few days record one with detailed prescribing information for doctors and pharmacists . A copy of the slides will go onto my website www.breastfeeding-and-medication.co.uk. Hope this helps everyone. I have found it necessary to leave several social media groups for my own sanity after reading threads where non evidence based practice seems to get perpetuated. This is my view after looking at thrush and breastfeeding for the last 20 years.
Posted by Breastfeeding and Medication on Friday, July 20, 2018
Medicalising Sore Nipples – thrush and breastfeeding July 2018
The origin of the BfN Breastfeeding and Thrush leaflet and factsheet
It feels a very long time since I recorded this video and it is now 25 years since Dr Magda Sachs and I wrote the first BfN leaflet about Thrush in Breastfeeding. At that time, as experienced breastfeeding supporters, we had seen maybe 6 mothers between us whose nipple pain had not been resolved by attention to positioning and attachment after months of breastfeeding without problem. We researched and found research about thrush and breastfeeding which exactly described what we were seeing. Those original references included :
Brent N., Thrush in the Breastfeeding Dyad: Results of a survey on diagnosis and treatment, Clin Paed. 2001; 40:503506.
Francis-Morrell J, Heinig MJ et al, Diagnostic value of signs and symptoms of mammary candidosis among lactating women. JHL 2004; 20:288-95 ›
Kaufman D, et al., Fluconazole prophylaxis against fungal colonisation and infection in preterm infants, N Eng J Med 2001; 345(23):1660-6.
Morrill JF et al. Risk factors for mammary candidosis among lactating women. J.Obstet.Gynecol. Neon.Nurse. 2005;34:37-45
We wrote the leaflet and then watched what became an avalanche of queries, recommendation and self diagnoses. Women repeated back to us the words such as “shark’s teeth” that we had used and we noted how hard they were trying to obtain treatment. We updated the leaflet a few years later and then wrote a factsheet as finances didnt allow further printing of leaflets.
Current research
There remains little research on thrush as a cause of nipple pain although it remains in the ABM Clinical Protocol #26: Persistent Pain with Breastfeeding https://abm.memberclicks.net/assets/DOCUMENTS/PROTOCOLS/26-persistent-pain-protocol-english.pdf
Do I still believe thrush affects breastfeeding women and causing nipple pain? Yes but in a small minority of cases. I think that most pain still comes from not quite positioning and attachment in the early days and often around 6 weeks when babies feed frequently and we assume that the latch is ok. I see another rush of instances of pain often described as thrush when babies are teething and again I think in most cases the latch has altered fractionally to take the pain off sore gums.
Miconazole oral gel
I do believe that miconazole gel is much more effective than nystatin drops and that is supported by research. However, there are current major national supply issues.
In 2008 Janssen-Cilag the manufacturers of Daktarin oral gel ® altered the licensed application of the product with respect to the age from which it is recommended. They recommend that it is not licensed for use in babies under 4 months of age and only with care between 4 and 6 months (EMC). I co-authored a paper published in the BMJ about this. https://www.bmj.com/content/338/bmj.a3178.long
This change appears to originate from a published report (De Vries 1996) documenting a 17 day old baby (born at 36 weeks gestation) who choked when exposed to miconazole oral gel applied to her mother’s nipples before and after feeds on the advice of a pharmacist. The baby suddenly stopped feeding and breathing, became cyanotic and lost consciousness. The mother scooped out the visible miconazole gel and the baby recovered within a few moments. The doctor who was called could find no abnormalities and the baby recovered without further problem. The report mentions nine other cases of babies who suffered some form of difficulty with breathing, one of who was admitted to hospital, but all recovered spontaneously.
The current research evidence for nystatin is poor according to Hoppe (1996, 1997).
If practitioners choose to continue to recommend miconazole oral gel they should ensure that the mother/carer is aware that the gel should be applied gently, in small amounts at a time until all the surfaces of the mouth are covered. It is important that a spoon is not used to administer the gel and that the back of the throat is not touched either by the adult’s finger or by the gel (Ainsworth 2009). Healthcare providers must ensure that when recommending this product that the parent/carer is aware of how to apply the gel safely i.e. using a clean finger, apply small amounts of gel at a time, four times a day after feeds. Practitioners who recommend miconazole oral gel that responsibility in a baby under 4 months lies with the person who prescribes or recommends its use. The licensed application does not necessarily imply a risk if used appropriately but each prescription should be considered on an individual basis. Under no circumstances should miconazole oral gel be applied to the mother’s nipples as a means of treating the baby or the mother.
-
- Ainsworth S and Jones W. It sticks in our throats too. BMJ 2009;337:3178
- De Vries TW, Wewerinke ME, de Langen JJ. [Near asphyxiation of a neonate due to miconazole oral gel Ned Tijschr Geneeskd 2006;148:1598–600
- Electronic Medicines compendium – miconazole oral gel SPC emc.medicines.org.uk
- Hoppe JE, Hahn H. Randomized comparison of two nystatin oral gels with miconazole oral gel for treatment of oral thrush in infants. Antimycotics Study Group. Infection. 1996 Mar-Apr; 24(2): 136-9.
- Hoppe JE. Treatment of oropharyngeal candidiasis in immunocompetent infants: a randomised multicenter study of miconazole gel vs. nystatin suspension. The Antifungals Study Group. Pediatr Infect Dis J. 1997 Mar; 16(3): 288-93.
Clotrimazole cream applied to the nipples
The lack of efficacy of clotrimazole cream applied to the nipples is anecdotal after supporting many women. The risk of it causing irritation comes from data supplied personally by Chloe Fisher and Sally Inch at the once famous breastfeeding clinic in Cambridge. Miconazole cream remains preferable in my opinion
The future?
I continue to believe that thrush affecting the breastfeeding dyad is rare and should only be used after all other reasons have been excluded or in the presence of positive swabs.
I refer you to another paper which I was involved in writing. “Identifying the cause of breast and nipple pain during lactation” https://breastfeeding-and-medication.co.uk/wp-content/uploads/2024/06/bmj.n1628.full-.pdf
https://breastfeeding-and-medication.co.uk/wp-content/uploads/2024/06/bmj.n1628.full-.pdf
and to this information from others https://breastfeeding-and-medication.co.uk/fact-sheet/what-do-mothers-want-healthcare-professionals-to-know-about-breast-and-nipple-pain-in-lactation
Queries can be sent to me wendy@breastfeeding-and-medication.co.uk
Semaglutide and Breastfeeding
Following the recommendation by NICE (March 2023) I looked at the evidence on semaglutide and breastfeeding. There are no current published reports, only theory from pharmacokietics.
It seems that there are no supplies just now either as I understand.
I have found the ZOE podcast interesting (no financial involvement) https://link.chtbl.com/s9cwxMzY
And Margaret MCartnetny view in the BMJ https://www.bmj.com/content/380/bmj.p624.full
Pdf of factsheet :
https://breastfeeding-and-medication.co.uk/wp-content/uploads/2023/03/semaglutide-and-breastfeeding-.pdf
Semaglutide binds to, and activates, the GLP-1 (glucagon-like peptide-1) receptor to increase insulin secretion, suppress glucagon secretion, and slow gastric emptying.
Semaglutide is used to treat Type 2 diabetes mellitus as monotherapy (if metformin inappropriate), or in combination with other antidiabetic drugs (including insulin) if existing treatment fails to achieve adequate glycaemic control. In March 2023 it was recommended for the treatment of obesity in specific circumstances.
Use in obesity.
Semaglutide (Wegovy™) was recommended by the National Institute for Health and Care Excellence (NICE) to treat thousands of people with obesity in England (March 2023). Semaglutide will be allowed to be prescribed to help people lose weight as part of their treatment in an NHS specialist weight management service. The drug works by suppressing appetite by mimicking the hormone glucagon-like peptide-1 (GLP-1), which is released after eating. It is injected once a week by patients. NICE first recommended the drug in draft guidance 2022, after a clinical trial of just under 2000 volunteers found that people lost on average 12% more weight with semaglutide alongside supervised weight loss coaching (BMJ 2023;380:556).
Guidelines for use in obesity
Semaglutide is recommended as an option for weight management, including weight loss and weight maintenance, alongside a reduced-calorie diet and increased physical activity in adults, only if:
- it is used for a maximum of 2 years, and within a specialist weight management service providing multidisciplinary management of overweight or obesity (including but not limited to tiers 3 and 4), and
- they have at least 1 weight-related comorbidity and:
- a body mass index (BMI) of at least 35.0 kg/m2, or a BMI of 30.0 kg/m2 to 34.9 kg/m2 and meet the criteria for referral to specialist weight management services in NICE’s guideline on obesity: identification, assessment and management.
Consideration should be made to stop semaglutide if less than 5% of the initial weight has been lost after 6 months of treatment. (https://www.nice.org.uk/guidance/TA875/chapter/1-Recommendations)
Currently Wegovy is not commercially available. Ozempic is available but is not licensed for weight management but only treatment of diabetes.
Dose
By subcutaneous injection( Ozempic™ ): Initially 0.25 mg once weekly for 4 weeks, then increased to 0.5 mg once weekly for at least 4 weeks, then increased if necessary to 1 mg once weekly.
By mouth (Rybelsus™): Initially 3 mg once daily for 1 month, then increased to 7 mg once daily for at least 1 month, then increased if necessary to 14 mg once daily, dose to be taken on an empty stomach, one 14 mg tablet should be used to achieve a 14 mg dose; use of two 7 mg tablets to achieve a 14 mg dose has not been studied and is therefore not recommended; maximum 14 mg per day.
By subcutaneous injection (Wegovy™): initially 0.25 mg once a week and increased every 4 weeks until the full dose of 2.4 mg is reached.
Compatibility with breastfeeding
- It is currently not known if semaglutide is excreted in human milk. The molecular weight of this medication means that it would have great difficulty entering breast milk. It is described as having oral bioavailability < 1% although an oral preparation exists. In consequence very little of this medication would be absorbed by the infant orally even if found in breast milk. The risk of this in a breastfed infant would be expected to be very low (Hale and Krutsch).
- Manufacturer advises avoid stating that it is present in milk in animal studies. so its use in a lactating mother would be outside of the product licence (BNF)
- No information is available on the clinical use of semaglutide during breastfeeding. Because semaglutide is a peptide molecule with a molecular weight of 4113 daltons and is over 99% protein bound, the amount in milk is likely to be very low. Absorption by the infant is unlikely because the drug is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, semaglutide should be used with caution during breastfeeding, especially while nursing a new-born or preterm infant. (https://www.ncbi.nlm.nih.gov/books/NBK500980/)
- Elactancia cites semaglutide as of very low risk in lactation (https://www.e-lactancia.org/breastfeeding/semaglutide/product/ ). Its high molecular weight and high fixation to plasma proteins make it very unlikely to pass into mothers’ milk in a clinically significant quantity. (Serrano 2015). In addition, due to its protein nature it is inactivated in the gastrointestinal tract, not being absorbed (practically null oral bioavailability), which hinders or prevents the passage into plasma of the infant from ingested breast milk (Serrano 2015), except in premature infants and during the immediate neonatal period, in which there may be greater intestinal permeability.
Common or very common side effects
Appetite decreased; burping; cholelithiasis; constipation; diarrhoea; dizziness; fatigue; gastrointestinal discomfort; gastrointestinal disorders; hypoglycaemia (in combination with insulin or sulfonylurea); nausea; vomiting; weight decreased (BNF).
There are recent reports of eye problems following use of semaglutide, https://www.aao.org/newsroom/news-releases/detail/weight-loss-drug-and-eye-health
Monitoring of nursling for side effects
Although adverse effects have not been noted the baby should be monitored for decreased appetite, abdominal distension, GERD, constipation, diarrhoea. (Hale and Krutsch)
Can my GP prescribe Wegovy™ in the UK for weight loss?
Semaglutide can only be prescribed as part of a specialist (tertiary) weight management service with multidisciplinary input and for a maximum of two years. https://www.nice.org.uk/guidance/ta875/chapter/1-Recommendations
Conception and contraception
Manufacturer advises women of childbearing potential should use effective contraception during and for at least two months after stopping treatment.
References
Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK501922/
Hale TW and Krutsch K Hale’s Medications & Mothers’ Milk™ 2023: A Manual of Lactational Pharmacology (online access HalesMeds.com January 2023)
Joint Formulary Committee (2022) British National Formulary. [Online]. London: British Medical Association and Royal Pharmaceutical Society of Great Britain. Available at: Medicines Complete Database, [Accessed January 2023].
Elactancia Is it compatible with breastfeeding? https://www.e-lactancia.org/
Serrano Aguayo P, García de Quirós Muñoz JM, Bretón Lesmes I, Cózar León MV. Tratamiento de enfermedades endocrinológicas durante la lactancia. [Endocrinologic diseases management during breastfeeding.] Med Clin (Barc). 2015 Jan 20;144(2):73-9.
Pharmacological methods of weaning versus conservative weaning
I have recently written an article for ELACTA on a subject that causes so many problems. Just this week I received this question ” I have a 30 week prem baby, I didnt want to braestfeed so they gave me a single dose of cabergoline and the baby is having donor breastmilk. I’ve changed my mind and I would love to feed her. Can I give her the milk I have expressed today?” It is such a difficult question as we have so little data on the passage of cabergoline into braestmilk, the baby is very premature so has poor kidney and liver function and expressing to get a full supply is going to be a long hard journey. On the day of delivering such a tiny precious bundle, it is so hard to take in the implications of taking the drug
ELACTA is a European Journal for European Lactation Consultants. “Lactation & Breastfeeding” is also available in the UK as an electronic version for €8 per issue ( 4 annual editions) if you are not a member of ELACTA. Single Issues (elacta-magazine.eu)
PDF of the article can be downloaded
https://breastfeeding-and-medication.co.uk/wp-content/uploads/2023/01/Pharmacological-methods-of-weaning-versus-conservative-weaning.pdf
There are several different reasons why a mother may wish to wean her baby from the breast if we accept that weaning for the purpose of this article means as the cessation of breastfeeding rather than introduction of appropriate complimentary solid foods:
- Physiological natural weaning because the mother has decided that the time is right for them and their baby to stop breastfeeding and there is a natural reduction of milk supply.
- Unintentional weaning which may include ongoing supplementation or as a side effect of medication
- The prescription of medication to reduce lactation in the puerperium such as following a stillbirth or neonatal death, a baby to be adopted or where the mother has chosen not to breastfeed
- To rapidly cease lactation at a later period because of a medical diagnosis e.g., a diagnosis of cancer, or more rarely because of initiation of a medication which is incompatible with breastfeeding initiation of long-term methotrexate or lithium
- The use of supplementary or complimentary products to reduce lactation which may include perceived over-supply
- To discourage an older nursling who is reluctant to stop breastfeeding
- To stop lactation following a stillbirth or baby loss
Physiological weaning
For the majority of women weaning from the breast occurs gradually over a period usually after the introduction of appropriate complimentary solid foods (). As such under the influence of the Feedback Inhibitor of Lactation (FIL) supply diminishes slowly and without symptoms or discomfort or need for medication. As the baby breastfeeds less the feedback inhibitor lowers the production of milk.
Unintentional weaning
However, some 80% of lactations in the UK ceased before the baby was 6 months old and before the mother had planned to stop, usually because of lack of support and perceived low milk supply (McAndrew et al., 2012) In this case usually breastmilk feeds have been replaced by formula milk feeds so that breastmilk supply has gradually reduced and ceased altogether. This sadly can happen because a mother has misunderstood the way that milk supply is stimulated or that a short-term feeding plan involving top ups of formula milk or replacement of breastfeeds has been continued longer than may have been anticipated by the professionals. Not reaching the goals of breastfeeding been shown to be associated with feelings of loss and grief (Brown,2019) (.
Suppression of lactation in the puerperium when mother has chosen not to breastfeed
Some mothers of course choose not to breastfeed from birth because of personal wishes or ill health of mother or baby. In the past many of them were prescribed medication to dry up their milk. Oladapo& Fawole ) conducted a review of 46 controlled trials that randomised a total of 5164 mothers to receive the treatment under investigation, no treatment or another treatment (Oladapo & Fawole, 2019). The trials were generally of limited quality, and most were conducted among healthy women who chose not to breastfeed for personal reasons at hospitals in industrialized countries before 1980. Half of the trials involved bromocriptine which is no longer recommended for routine suppression of lactation and has indeed been withdrawn in USA by the FDA due to numerous maternal deaths.
Adoption
In the past many women whose babies were to be placed for adoption were offered medication to suppress lactation presumably to diminish the grief of the separation. In some cases, where limited contact with the baby is being maintained under supervision, mothers may choose to provide some breastmilk which can either be given as expressed breastmilk by the carer or directly by the mother feeding during contact. Anecdotally there have been reports to social services (personal communications to the author) where foster mothers have reported concerns that following maternal breastfeeds the baby appeared to have loose bowel motions and that the mother may be passing unacceptable substances via breastmilk. This exemplifies a misunderstanding of the difference between the bowel motions of breast and formula milk fed babies. There appears to be little research on the subject suggesting that long term expression is rare for babies given up for fostering and adoption. Whilst breastfeeding a baby who is to be adopted seems to be more common (Gribble 2006)
Stillbirth or neonatal death
For some mothers the choice to donate their breastmilk, following loss of their baby is a comfort and seen as a tribute to the baby’s memory (Jones, 2018) .
“When I gave birth to my stillborn daughter, I was given a dry up shot without them even mentioning donating to milk banks as an option. I would have LOVED donating my milk. ”“It’s funny, no one told me about milk donation. I don’t know how I knew about it. I learned when I was planning the C-section, I knew donor milk was an option, but didn’t know who donated it, never suspected I would become one who would be a milk donor.”
The side effects of cabergoline, used to stop lactation are not insignificant and it can precipitate depression, already a high risk after baby death in the puerperium.
Some mothers (personal communication to the author) were encouraged to not express their milk after sick, pre-term birth “just in case” their baby didn’t survive. In each of the cases, although limited in number, the mothers expressed regret that they felt that they had been excluded from caring for their baby.
Unintentionally lowering of milk supply due to medication
Drugs known to lower milk production as a side effect of use as medication are the combined contraceptive pill and the decongestant pseudoephedrine. Use to deliberately lower supply is not supported by research and effects vary with individuals. There have been no clinical trials on use for this purpose. Side effects of the drugs may be to raise the blood pressure of the mother and cause restlessness and irritability in the baby.
In one study of eight mothers (Aljazaf et al., 2003) a single dose of 60 mg pseudoephedrine was found to reduce the breastmilk supply by 24%. The reduction appeared to be more pronounced in those with later stage lactation defined as more than 60 weeks. The authors proposed that this may be due to a reduction in the production of prolactin although the reduction did not reach statistical significance with this small study population. Theoretically the reduction is also possible with the more frequently used phenylephrine although this hasn’t been reported in studies (Hale & Krutsch 2022, ) .
Dr Jack Newman has reported that bromocriptine and cabergoline are prescribed to overcome the symptoms of engorgement and mastitis sometimes on a routine basis (Newman, 2014) without the mother being aware of the potential effect on her long-term chances of successful breastfeeding.
Early post-partum use of the combined oral contraceptive pill has been shown to decrease milk supply in some women due to the oestrogenic activity. However, the reduction seen is not consistent and seems to vary from woman to woman. The studies available are very dated and evidence relies on anecdotal reporting by mothers and lactation specialists.
Other non-prescribed products used to reduce lactation
The herb sage has been reported to lower milk supply although without clinical research. In 2014 Eglash stated that “Sage is the most common herb used to reduce milk supply. Sage tea or extract made from the leaves is typically recommended, although there are no studies on the use of sage for hypergalactia and very few on its effect on the nursing baby. Sage tea may be prepared by steeping 1–3 g of dried sage leaves in a cup of hot water. The mother should be advised to just use one dose of the extract or 1 cup of tea and to observe the effect on her supply, as well as any behavioural change in the baby, over the next several hours. If she does not notice a difference in supply in 8–12 hours, then she can try another, stronger dose. Once she sees a response, she should just use it as needed. Often women will use one dose every 12 hours for 3 days to keep their supply down. Sage is known to have several side effects in high doses, including nausea, vomiting, and dizziness. It can induce wheezing, lower the blood sugar, and induce seizures, so high doses should be avoided in asthmatics, diabetics, and people prone to seizures. It is considered safe when used as a food.
In a 1998 Shrivastavet al studied the use of topical application of jasmine flowers was compared to bromocriptine to suppress lactation immediately after birth(. They reported that “The efficacy of jasmine flowers applied to the breasts to suppress puerperal lactation was compared to that of Bromocriptine. Effectiveness of both regimens was monitored by serum prolactin levels, clinical evaluation of the degree of breast engorgement and milk production and the analgesic intake. While both bromocriptine and jasmine flowers brought about a significant reduction in serum prolactin, the decrease was significantly greater with bromocriptine. However, clinical parameters such as breast engorgement, milk production and analgesic intake showed the two modes of therapy to be equally effective. The failure rates of the two regimens to suppress lactation were similar; however, rebound lactation occurred in a small proportion of women treated with bromocriptine. Jasmine flowers seem to be an effective and inexpensive method of suppressing puerperal lactation and can be used as an alternative in situations where cost and nonavailability restrict the use of bromocriptine.”
KellyMom reports that other herbs can be used to decrease supply but no evidence from research is supplied to support the statement. The herbs include Peppermint, Spearmint, Parsley, Chickweed, Black Walnut, stinging nettles, Yarrow, Herb Robert Lemon Balm, Oregano, Periwinkle Herb, Sorrel (KellyMom, 2018).
Normal consumption of the herbs as foodstuffs or drinking peppermint tea would not be likely to decrease supply.
Medication to reduce lactation
Bromocriptine
In 2015, the French pharmacovigilance program( Bernard) published a review of the adverse events associated with bromocriptine use to cease lactation. This group reported 105 serious adverse reactions including cardiovascular (70.5%), neurological (14.4%) and psychiatric (8.6%) events. There were also two fatalities: one 32-year-old female had a myocardial infarction with an arrhythmia, and a 21-year-old female had an ischemic stroke. (Hale & Kutsch 2022)(8)
Cabergoline
If a dopamine-receptor agonist is required to suppress lactation, cabergoline is preferred at a dose one mg, to be taken as a single dose on the first day postpartum. For the suppression of established lactation, a dose of 0.25mg is taken every 12 hours for two days for a total of 1mg (BNF 2022). However, this drug also has significant side effects, including headache, dizziness, fatigue or insomnia, orthostatic hypotension, oedema, nosebleed, dry mouth, inhibition of lactation, nausea, constipation, anorexia and weakness.
The manufacturer’s summary of product characteristics (Electronics Medicines Compendium SPC) ( states that:
“As with other ergot derivatives, cabergoline should not be used in women with pregnancy-induced hypertension, for example, preeclampsia or post-partum hypertension, unless the potential benefit is judged to outweigh the possible risk.
Serious adverse events including hypertension, myocardial infarction, seizures, stroke or psychiatric disorders have been reported in postpartum women treated with cabergoline for inhibition of lactation. In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances. Blood pressure should be carefully monitored after the treatment. If hypertension, suggestive chest pain, severe, progressive, or unremitting headache (with or without visual disturbances), or evidence of central nervous system toxicity develop, cabergoline should be discontinued and the patient should be evaluated promptly.
In post-partum studies with cabergoline, blood pressure decreases were mostly asymptomatic and were frequently observed on a single occasion 2 to 4 days after treatment. Since decreases in blood pressure are frequently noted during the puerperium, independently of drug therapy, it is likely that many of the observed decreases in blood pressure after cabergoline administration were not drug-induced. However, periodic monitoring of blood pressure, particularly during the first few days after cabergoline administration, is advised”.
Cabergoline can also cause depression. They should be avoided if the mother has experienced pre-eclampsia. Both drugs can produce sudden onset sleep or excessive daytime drowsiness and driving should be avoided.
Although bromocriptine and cabergoline are licensed to suppress lactation, they are not recommended for routine suppression when women have decided not to breastfeed, or for the relief of symptoms of postpartum pain and engorgement that can be adequately treated with simple analgesics and breast support. Should the mother decide that she wants to continue to breastfeed after taking cabergoline caution is recommended as there are no studies on the effects on babies of the dose used to suppress lactation (Hale and Krutsh 2022). Elactancia suggests that “No untoward effects have been reported in breastfed infants of mothers who were treated (or erroneously had received medication) and decided to resume breastfeeding” whilst recommending waiting 3-7 half lives. The half life of cabergoline is 63-69 hours.
Weaning the reluctant nursling
Social media posts often have posts from mothers who are experiencing aversion to breastfeeding, sometimes around the time of menstruation, or because their babies are “nipple twiddling”. They report that they are desperate to stop breastfeeding whilst their nursling remains bonded and even reliant on breastfeeding. Discussions that they have felt unable to convince their little ones that milk has dried up are undermined when the nursling latches on and finds there is milk. They often question whether taking a medication to suppress lactation would be an option as a strategy of last resort!
“So, unless I can come up with a better plan, I need to dry my milk up. I bedshare with my 23-month-old (no other options), am a solo parent, and night nurse all night long (her choice, not mine). I planned to keep breastfeeding for as long as she wanted but I can’t nurse her at night anymore. I have no clue how to night wean her because I’m literally lying next to her all night long. So, I figured the easiest thing to do would be to dry my milk up with drug. “
Conclusion
In an ideal world it is better to allow the breastmilk supply to dwindle slowly, by dropping one feed at a time or expressing/feeding only when the breasts become uncomfortably full. It may however be necessary to speed up this process up, but it is still important to avoid blocked ducts and mastitis. It is possible to treat the breasts as in the early days of engorgement, using simple analgesics and cold savoy cabbage leaves in a firm but well-fitting bra. Or the mother can express just enough milk to remain comfortable, frequently changing breast pads, which may become soaked as milk leaks from the breasts. Restricting the fluids which the mother is drinking will not help the milk to dry up; nor will the use of laxatives to remove water from the body.
Whose choice should it be?
The choice should ultimately be that of the lactating mother having been provided with full information about the side effects of the drug, alternative methods of reducing supply and that this should be a final decision. So many times, mothers say that they have taken cabergoline but regret the decision and wish to return to breastfeeding, for example that formula isn’t suiting their baby. As with so many aspects of parenthood it isn’t always as easy a professionals might suggest.
References
- Aljazaf K, Hale TW, Ilett KF, et al. (2003) Pseudoephedrine: effects on milk production in women and estimation of infant exposure via breastmilk. Br J Clin Pharmacol. 56(1):18-24
- Bernard N, Jantzem H, Pecriaux C, et al. Severe adverse effects of bromocriptine in lactation inhibition: a pharmacovigilance survey. BJOG. 2015;122:1244-1251.
- Brown A, Why Breastfeeding Grief and Trauma Matter Pinter and Martin 2019
- Dr Jack Newman Facebook social media https://www.facebook.com/DrJackNewman/posts/the-use-of-cabergoline-dostinex-and-bromocriptine-parlodel-in-breastfeeding-wome/311003792384007/
- Eglash A. (2014)Treatment of maternal hypergalactia. Breastfeed Med. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4216483/pdf/bfm.2014.0133.pdf
- Elactancia online database https://www.halesmeds.com/monographs/60947?q=cabergoline
- Electronics Medicines Compendium SPC bromocriptine https://www.medicines.org.uk/emc/product/1202
- Cabergoline https://www.medicines.org.uk/emc/product/1691/smpc (accessed December 2022)
- Gribble, K.D. (2006) Mental health, attachment and breastfeeding: implications for adopted children and their mothers. Int Breastfeed J 1: 5
- Hale TW and Krutsch K Medications and Mothers Milk online access December 2022).
- Joint Formulary Committee. (2022). British national formulary. Accessed December 2022, fromhttps://www.medicinescomplete.com/#/browse/bnf
- Jones W Breastfeeding and Medication website lowering or stopping breastmilk supply https://breastfeeding-and-medication.co.uk/fact-sheet/breastfeeding-and-lowering-stopping-milk-supply
- KellyMom Herbs that may decrease milk supply https://kellymom.com/bf/got-milk/herbs_to_avoid/ Accessed December 2022
- McAndrew F, Thompson J, Fellows L, Large A, Speed M, Renfrew MJ (2012) Infant Feeding Survey 2010, Health and Social Care Information Centre
- Oladapo, O.T.; Fawole, B. (2009) Treatments for suppression of lactation. Cochrane Database of Systematic Reviews
- Shrivastav P, George K, Balasubramaniam N, Jasper MP, Thomas M, Kanagasabhapathy AS. Suppression of puerperal lactation using jasmine flowers (Jasminum sambac). Aust N Z J Obstet Gynaecol. 1988 Feb;28(1):68-71
Raynaud’s and Breastfeeding
Raynaud’s phenomenon affects up to 10% of otherwise healthy women aged 21-50 years of age. It is 9 times more common in women than men.
Yet many doctors are unaware that Raynaud’s can affect breastfeeding. It produces deep pain after feeds with a mother often automatically covering her nipples or massaging them to restore the blood flow. Symptoms are often mis-diagnosed as thrush when in fact the use of fluconazole can make the symptoms worse by causing further vasoconstriction.
Most mothers who experience problems with Raynaud’s during breastfeeding, have a history of cold hands and feet or a close relative who has. It may be that in a family it is routine to wear thick socks and gloves, maybe a vest without realising that they may be “unusual” in their response to the cold.
Babies of mothers with Raynaud’s may be born early and / or smaller because of restriction of blood flow to the placenta. It is not uncommon for there to be a maternal (or close family) history of migraines.
Symptoms which differentiate Raynaud’s phenomenon with other causes of breast pain are:
- Pain in both breasts after feeds
- Pain which may be precipitated by being cold or for example going down the freezer aisle in a supermarket
- Rapid 3 colour change in the nipples after feeds
- Pain that is resolved by warmth or gentle massage
- A history or close family history of poor circulation
Treatment of Raynaud’s during breastfeeding
- Don’t ignore the fact that pain after breastfeeds may be due to less than perfect attachment of the baby at the breast. A white tip to the nipple after feeds is not the same as the tri colour change typical of Raynaud’s
- Nifedipine 30-60mg a day (either as 10-20mg three times a day or long acting dose once daily. The amount in breastmilk is too small to affect babies although it may give the mother hot flushes and / or headaches.
- The following extract is taken from Breastfeeding and Medication 2nd Ed to be published May 2018
- High doses of vitamin B6 (Newman 2012), magnesium (Smith 1960, Turlapaty Leppert1994), calcium (DiGiacomo 1989), fatty acids (Belch 1985) and fish oil supplementation (DiGiacomo 1989) have also been suggested but take a minimum of 6 weeks to be effective. Ginger 2000mg-4000mg daily. Capsules usually contain 500mg. It may also be beneficial to add ginger to your diet, to drink ginger tea, or to put a spoonful of ground ginger in your bathing water (Royal Free hospital www.royalfree.nhs.uk/pip_admin/docs/Raynaudsnatural_186.pdf)
Nifedipine
Nifedipine relaxes vascular smooth muscle and dilates coronary and peripheral arteries. It has activity in reducing blood pressure and in the treatment of Reynaud’s syndrome
Nifedipine is almost completely absorbed from the GI tract but undergoes extensive first-pass metabolism. It is up to 98% bound to plasma proteins. It is used to treat hypertension (Penny and Lewis 1989; Ehrenkranz et al. 1989) and also to improve circulation in Reynaud’s disease (cold extremities and nipple vasospasm) in doses up to 30 mg daily (Lawlor-Smith and Lawlor-Smith 1996; Garrison 2002; Anderson et al. 2004). Side effects for the mother include flushing and headache, which may limit its usefulness. It is present in breastmilk but in levels too small to be harmful and there have been no reports of adverse effects in babies (see Chapter 5).
In Taddio et al’s study (1996) of 21 women taking 40 mg daily the babies were estimated to be exposed to 0.1% of the maternal weight adjusted dose via breastmilk. Nifedipine is widely used to treat pre-eclampsia and eclampsia in the mother together with methyldopa or a beta blocker. Ehrenkranz et al. (1989) studied one woman who took 10, 20 or 30 mg three times daily on different days. Using the maximum dose transferred by the 30 mg regimen, the authors estimated that the baby would be exposed to the authors estimated that an exclusively breastfed infant would receive an estimated maximum of 7.5 µg per kilogramme of nifedipine daily. Its relative infant dose is quoted as 2.3–3.4% (Hale 2017 online access).
The BNF reports that the amount secreted into breastmilk is too small to be harmful but that manufacturer advises it should be avoided.
Compatible with breastfeeding.
References
- Anderson JE, Held N, Wright K, Raynaud’s phenomenon of the nipple: a treatable cause of painful breastfeeding, Pediatrics, 2004;113(4):e360–4.
- Ehrenkranz RA, Ackerman BA, Hulse JD, Nifedipine transfer into human milk, J Pediatr, 1989;114:478–80.
- Garrison CP, Nipple vasospasm, Raynaud’s syndrome, and nifedipine, J Hum Lact, 2002;18(4):382–5.
- Lawlor-Smith LS, Lawlor-Smith CL, Raynaud’s phenomenon of the nipple: a preventable cause of breastfeeding failure?, Med J Aust, 1996;166:448. Letter.
- Penny WJ, Lewis MJ, Nifedipine is excreted in human milk, Eur J Clin Pharmacol, 1989;36:427–8.
- Taddio A; Oskamp M; Ito S; Bryan H; Farine D; Ryan D; Koren G,. Is nifedipine use during labour and breastfeeding safe for the neonate?, Clin Invest Med, 1996;19(4 Suppl.):S11. Abstract.
- Quental C, Brito DB, Sobral J, Macedo AM. Raynaud Phenomenon of the Nipple: A Clinical Case Report. J Family Reprod Health. 2023 Jun;17(2):113-115. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10397528/pdf/JFRH-17-113.pdf
- Deniz S, Kural B. Nipple Vasospasm of Nursing Mothers. Breastfeed Med. 2023 Jun;18(6):494-498
- Di Como J, Tan S, Weaver M, Edmonson D, Gass JS. Nipple pain: Raynaud’s beyond fingers and toes. Breast J. 2020 Oct;26(10):2045-2047