as written for Maternity and Midwifery Forum Vaccinations in pregnancy and breastfeeding – Maternity & Midwifery Forum

The long-term impact of the use of thalidomide for nausea in the 1960’s continues to be in the minds of many pregnant women and their families. They fear exposing their growing baby to anything from foods to medicines to passive smoking. The anti-vax campaign after COVID-19 still lurks when we discuss the benefits of vaccination in pregnancy. Women should not be dismissed but their fears acknowledged, and evidence-based information provided.

We can share with them that vaccination is recommended for Flu and COVID-19 as their own immunity is supressed in pregnancy making them more prone to infections which can be more severe than normal. In addition, no vaccination would be added to the schedule without significant consultation on risks and benefits by the UK Teratology Information Service. The vaccines are also given to protect the vulnerable newborn from infections and possible hospitalisation.

Active listening

As part of my training as a volunteer breastfeeding supporter I learned about active listening and how that can help someone clarify their fears, doubts and intentions. I have continued to use these in all areas of my professional practice and within the family!

These skills include:

• making eye contact, if possible (many of us, as healthcare professionals, are busy filling in forms and records as we talk!),
• picking up the non-verbal clues (how are they sitting, sounding?),
• not interrupting or phrasing the question with an implied agreement. For example, “so you are going to have the vaccine, aren’t you?” But maybe “at this stage in pregnancy we normally offer vaccine x, how do you feel about that? Do you have any questions?”
• unconditional respect for that decision, we are not in a position to judge. You could offer further information for the family to look at and discuss. Written information is powerful. Think how many people believe everything they find on google searches! Ensure that you are providing appropriate evidence-based information.
• show that you are listening by nodding and don’t pass on your opinions.
• paraphrase back to the family the concerns that they might have expressed. “So, I’m hearing that you have seen some experiences and opinions on social media that are concerning you. Is that correct?”
• ask open questions rather than anything to which the expected reply is yes or no.

We cannot force vaccinations onto pregnant women without addressing their concerns, if they have them. Otherwise, they may worry for the rest of the pregnancy that they have damaged this precious baby which may not have been conceived simply and on who great hopes are placed. NICE has particularly emphasised that all healthcare professionals should be facilitating shared patient choses in all aspects of their care. The vaccinations recommended in pregnancy are currently Flu, COVID-19, Whooping Cough, Respiratory syncytial virus (RSV) vaccine.

Flu vaccine

Flu vaccination is recommended in pregnancy to protect the woman from complications of flu and to help prevent the baby from catching flu in the first few weeks after delivery. Pregnant women are more likely to suffer complications such as chest infections and pneumonia.    https://www.medicinesinpregnancy.org/leaflets-a-z/flu-vaccine/

Whooping Cough vaccine

The whooping cough vaccine is given sometime after 16 weeks but normally around 20 weeks. Some immunity passes across the placenta protecting the neonate until it can have its own vaccination. There has been an increase in cases of whooping cough reported over the past year and the youngest babies are at greater risk of severe illness and hospitalisation. There are sadly even reports of infant death. https://www.medicinesinpregnancy.org/leaflets-a-z/whooping-cough-vaccine/

Respiratory syncytial virus (RSV) vaccine

The new RSV vaccine given to the mother (available from 1.9.24) protects the baby for the first 6 months after birth from severe lung infections which may make it difficult for babies to breathe and necessitate hospital admission. The vaccine is normally offered around 28 weeks of pregnancy. RSV is a common virus that causes coughs and colds but can lead to bronchiolitis in babies making it difficult for them to breathe and feed. https://www.gov.uk/government/publications/respiratory-syncytial-virus-rsv-maternal-vaccination/a-guide-to-rsv-vaccination-for-pregnant-women

COVID-19 vaccine

The COVID-19 vaccine can be given at any stage in pregnancy. It protects both mother and baby. Pregnant mothers who develop COVID-19 can become seriously ill. If the mother contracts it late in pregnancy the baby may become seriously unwell and need to be admitted to special care. https://www.medicinesinpregnancy.org/leaflets-a-z/covid-19-vaccine/

Live virus vaccines

Vaccines to be avoided in pregnancy include all those which contain live virus. These include MMR, BCG and Oral typhoid, polio and yellow fever

Vaccination during breastfeeding

Breastfeeding mothers can have all routine vaccinations which they may have missed, and which are injected e.g. MMR, Flu, COVID-19.

The vaccines are not transmitted through breastmilk as they are poorly orally bioavailable and so cannot be absorbed from breastmilk. Healthcare workers can receive hepatitis vaccines without interrupting breastfeeding.

Other vaccines which can be used are chickenpox, hepatitis a and c, pneumonia, tetanus, typhoid, BCG, DipPT, whooping cough, injected polio vaccine (but not oral drops).

Children’s vaccines which can affect the mother.

Immunocompromised mothers i.e. those taking drugs such as azathioprine, biological drugs (Infliximab, Humira™ etc) should wear gloves when changing nappies for 2 weeks if their baby is given rotavirus drops as part of their routine immunisation. This is because live viral particles are shed in faeces for two weeks. https://breastfeeding-and-medication.co.uk/fact-sheet/live-vaccinations-and-immunosuppressant-medication-taken-by-breastfeeding-mothers

Immunotherapy drugs given during pregnancy.

If the mother continued biological drugs during pregnancy the baby should not receive the rotavirus drops for at least 6 months (12 months for infliximab). This is because sufficient of the drugs pass the placenta to impact on the baby’s immunity. Other vaccines to avoid are BCG if that is necessary because the baby is at increased risk of contracting tuberculosis. https://www.nhs.uk/vaccinations/bcg-vaccine-for-tuberculosis-tb/

Although MMR vaccine contains a live virus there is little evidence of risk to an immunocompromised mother[JH1] .

The card below was developed by Lorna Orriss-Dib at Healthwatch Essex as a resource for mothers with Inflammatory Bowel Disease to be stuck into the Red Book. Some healthcare professionals were not aware of the risks to women taking medication which caused them to be immunocompromised during pregnancy or when their babies received live vaccines, according to a study undertaken by Lorna. I have also witnessed this on the Facebook group which I administer for breastfeeding mothers with IBD. The card was developed as a simple tool to be ensure everyone was fully informed of the risks and benefits. Healthwatch Essex are keen that it can be widely disseminated to other areas.

The information applies whether the mother is breastfeeding or using infant formula if she is immunocompromised.

In summary:

• For mothers who were taking biological medication in the third trimester of pregnancy, their babies, should not receive live vaccinations before at least 6 months of age
• Mothers who are immunocompromised may be infected by faecal particles shed following the use of rotavirus vaccine to their baby and should take hygiene precautions

Image developed by Lorna Orriss-Dib at Healthwatch Essex Reproduced with consent and can be widely disseminated ).

Further information

Breastfeeding and Medication https://breastfeeding-and-medication.co.uk/fact-sheet/vaccines-and-breastfeeding

Immunisation against infectious disease. The Green Book https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

Kroger AT, Atkinson WL, Marcuse EK, Pickering LK, Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR Recomm Rep, 2006;55(RR-15):1–48.

Plotkin SA, Orenstein WA, Vaccines 4th edition, Philadelphia: WB Saunders, 2004 (cited in Department of Health Green Book chapter 34).

Using vaccines during breastfeeding https://www.nhs.uk/vaccinations/bcg-vaccine-for-tuberculosis-tb/

Vaccines in pregnancy Public Health Scotland https://www.youtube.com/watch?v=yqGN2tivZT4

UK Teratology Information Service. https://uktis.org/

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I’m really saddened that so many mothers are recommended to stop breastfeeding in order to be treated with medication. There is some evidence that breastfeeding in itself protects the mother

Research on Rheumatoid Arthritis

I hope that this factsheet provides some alternatives. The information is taken from Breastfeeding and Chronic Medical Conditions – https://tinyurl.com/mbbebe8x

RA and Breastfeeding Factsheet

“Recovering from childbirth is horrendous enough (well it was for me), never mind having RA
symptoms on top of it. I met with my consultant 3 weeks after the birth, and straight away she was
urging me to stop breastfeeding and trying to get me to begin courses of strong medication.
Overwhelmed by the pain, the sleepless night, and the huge amount of information she was throwing
at me, I found it very hard to take much of what she said in. I just knew I wanted to do the best for
my baby. Appointments with rheumatology since have been similar, pushing me to stop
breastfeeding, not listening to my reasons for wanting to breastfeed, and pushing the stronger
meds.”
“In autumn 2016 I noticed my left thumb was sore a lot of the time. Thinking I had hurt it in
somehow, I did not do anything more about it. Soon after I noticed the rest of my fingers and hands
starting to ache. There were days in work where I could not do my job properly, because my hands
were so sore, and I could barely stand to wash my hands, the pain was so severe. A few bloods taken
in January 2017 by my GP, revealed that I had developed Rheumatoid Arthritis. There is no history of
it in my family, and I knew very little about it. I waited several months for my first rheumatology
appointment at the hospital. When I eventually got my appointment, several months later, I was
pregnant with our second baby, and was amazed that the pregnancy had almost completely
eliminated my RA pains. The consultant warned me that after my baby arrived the RA would hit me
hard. And wow was she right.”
“I have seropositive erosive rheumatoid arthritis. I was diagnosed in July 2019. I breastfed my toddler
until he was nearly 17 months but stopped due to entering the 2nd trimester of pregnancy, by then
he was ready to stop and so was l. When l was diagnosed my baby was 10months old. It appears l
may have had RA since l was 17 but did not realise. I was told to stop breastfeeding by many nurses,
GPs and rheumatologists. As l had 7 years of infertility and 3 failed IVF l was desperate to not stop
breastfeeding until l thought my son was ready. I thought he would be my only baby. I have anxiety
and suffer from frequent panic attacks, but breastfeeding helped me manage the emotions and
exhaustion of motherhood. Through seeking guidance from you l asked my rheumatologist if l could
be put on Sulfasalazine which is safe for breastfeeding. It was very slow and ineffective to treat my
active inflammation at the start but allowed me to continue my breastfeeding journey. They wanted
to put me on methotrexate which is not suitable for breastfeeding. They gave me 4 massive injections
of steroids to try and get my RA under control over a period of a few months. My inflammation was
still sky high. When l found out l was pregnant in November 2019 l went into remission with the
change in hormones. I was put on Cimzia (biologic) just before Christmas to prevent any further
erosions in my feet. I have had to come off Cimzia a few days ago, due to a high risk of severe
symptoms if l catch Corona Virus as technically, they think my disease activity has only been reduced
due to pregnancy hormones. I am now 26 weeks pregnant. I hope l do not flare in trimester 3 or
when the baby is born because then they may force me to take methotrexate and another immune
suppressing biologic. I desperately hope to breastfeed baby 2 but understand this pandemic may not
be going away any time soon. I want to be safe for my children. Thank you for your advice because
you enabled me to continue to feed my baby for another 9 months more after diagnosis. I feel a lot of
people including many in the medical profession think if you have fed your baby until they are on
solids then it is not necessary to keep on breastfeeding. By understanding what meds are safe for
breastfeeding a lot of women have more choice to decide when it is right for them to give up.”

“Would I be in a better position if I weren’t breastfeeding? The consultant could not answer that.
Every case is different, and everyone responds differently to the medicine. There is no proof that if I
stopped, I would be in less pain, so I am happy to feed my boys for as long as they keep wanting me
to. I am trying exercise, physio and dietary changes to help reduce pain, instead of relying solely on
medication. I am taking it one day at a time, and I love being a Mummy more than anything.
Breastfeeding is so much more than just giving your child nourishment, it is quality time together, a
special bond between mum and baby, which I will never forget. I will always cherish my years of
breastfeeding, the cuddles, smiles and love we have shared together. Yes, I have rheumatoid
arthritis, but it does not define me. Always remember, never give up on a hard day. Tomorrow is
another beginning.”
Description
Rheumatoid arthritis (RA) is a common chronic inflammatory autoimmune disease. It is associated
with significant pain and disability. Control of the inflammation in the early stages can prevent long
term damage which is why consultants are keen to use disease modifying agents as soon as possible.
The overall occurrence of RA is two to four times greater in women than in men. The peak age of
incidence in the UK for both genders is the 40s, but people of all ages can develop the disease. There
is a genetic influence in developing the condition, but it is also linked with environmental factors,
such as high birth weight, smoking, silica exposure, alcohol abstention, obesity, and diabetes
mellitus.
There is evidence (NICE 2015) that the first 12-week period of the disease represents a unique
opportunity to influence the progress of the disease. The challenge is to recognise early symptoms
see a specialist. Presenting symptoms can be very variable: profound fatigue, influenza-like
symptoms, fever, sweats and weight loss are common. Other organs can be involved. Typically, there
may be periods of exacerbations and remissions, but it may be mild self-limiting condition or a
chronic progressive illness.

Treatment
There is evidence that breastfeeding protects against the risk of developing rheumatoid arthritis
(Chen 2015). No protective effect was noted from simply having children and not breastfeeding, or
from taking oral contraceptives (Pikwer 2008)
Drugs for rheumatoid arthritis which can be taken during breastfeeding:
Non-steroidal anti-inflammatory drugs (NSAIDS)
Ibuprofen: very low levels in breastmilk. Can be used even when baby needs direct
ibuprofen syrup e.g. during teething or fever
diclofenac: has historically been widely used in breastfeeding
naproxen: longer half-life than diclofenac or ibuprofen but levels in breastmilk low
celecoxib: low levels in breastmilk
Mefenamic acid – no studies but BNF states “amount in milk too small to be
harmful”
Ketoprofen: low levels in breastmilk, one centre in France 8/174 incidences of
adverse events including oesophageal ulceration, erosive gastritis, meningeal
haemorrhage, and renal insufficiency.

Meloxicam: Limited oral bioavailability but no studies.

Etoricoxib – no data , celecoxib preferable

Indometacin: One case of seizure reported in neonate exposed through milk. Avoid as safer
alternatives
all of the above with PPI omeprazole to protect the mother’s stomach.
DMARDS such as Hydroxychloroquine (see Lupus) but not methotrexate are acceptable
Biologicals – etanercept, infliximab, adalimumab, rituximab. All have large molecular
weights which produce zero oral bioavailability. Certolizumab pegol has a licence for use by
breastfeeding mothers.
Where opiates are required dihydrocodeine would be the drug of choice as it has a cleaner
metabolism than codeine. Tramadol is also acceptable

References

• Davies NM, Anderson KE, Clinical pharmacokinetics of naproxen, Clin Pharmacokinet,
  1997;32:268–93.
• Eeg-Olofsson O, Malmros I, Elwin CE, Steen B. Convulsions in a breast-fed infant after
  maternal indomethacin. Lancet. 1978;2 (8082):215. Letter Gardiner SJ, Doogue MP, Zhang
  M, Begg EJ, Quantification of infant exposure to celecoxib through breastmilk, Br J Clin
  Pharmacol, 2006;61:101–4.
• Hale TW, McDonald R, Boger J, Transfer of celecoxib into human milk, J Hum Lact,
  2004;20(4):397–403.

• Ito S, Blajchman A, Stephenson M, Prospective follow-up of adverse reactions in breastfed
  infants exposed to maternal medication, Am J Obstet Gynecol, 1993;168:1393–9.
• Jamali F, Stevens DRS, Naproxen excretion in milk and its uptake by the infant, Drug Intell
  Clin Pharm, 1983;17:910–11.
• Knoppert DC, Stempak D, Baruchel S, Koren G, Celecoxib in human milk: a case report,
  Pharmacotherapy, 2003;23(1):97–100.
• NICE CG 79 2015. Rheumatoid arthritis in adults: management
• Soussan C, Gouraud A, Portolan G et al. Drug-induced adverse reactions via breastfeeding: a
  descriptive study in the French Pharmacovigilance Database. Eur J Clin Pharmacol. 2014;
  70:1361-6
• Townsend RJ, Benedetti TJ, Erickson SH, Cengiz C, Gillespie WR, Gschwend J, Albert KS,
  Excretion of ibuprofen into breastmilk, Am J Obstet Gynecol, 1984;149(2):184–6.
• Walter K, Dilger C, Ibuprofen in human milk, Br J Clin Pharmacol, 1997;44:211–12.
• Weibert RT, Townsend RJ, Kaiser DG, Naylor AJ, Lack of ibuprofen secretion into human milk,
  Clin Pharm, 1982;1:457–8.
  .
  Further Information
  National Rheumatoid Arthritis Society https://www.nras.org.uk/

Doxylamine/pyridoxine (Xonvea™, Cariban™)

This is the only licensed drug treatment for nausea and vomiting of pregnancy. It contains a combination of the antihistamine doxylamine and the vitamin pyridoxine. It became available in England in 2018. It has been widely used for pregnancy sickness in the US and Canada and studies have shown no link with birth defects in the baby. The antihistamine doxylamine might be more likely to cause drowsiness in nursling. https://www.ncbi.nlm.nih.gov/books/NBK500620/  and https://www.e-lactancia.org/breastfeeding/doxylamine-succinate/product/. The 10mg of pyridoxine is unlikely to cause any disruption to breastfeed.

See also Vomiting in pregnancy whilst still breastfeeding – Breastfeeding and Medication

pdf https://breastfeeding-and-medication.co.uk/wp-content/uploads/2024/11/eczema-dermatitis-and-breastfeeding.pdf

We have known for many years that many women give up breastfeeding in the first 6 weeks with unresolved nipple pain and damage.

There is currently discussion about the treatment of thrush during breastfeeding and that many cases may be wrongly diagnosed and be caused by dermatitis (eczema).

CKS How should I diagnose the cause of nipple pain? 2022 mentions that:

• Eczema, psoriasis and contact dermatitis of the areola and nipple may cause itching of the skin.
• Eczema typically causes a bilateral red, dry, scaly rash which may have lichenified (thickened) areas, which tend to spare the base of the nipple.
• Psoriasis typically causes red plaques with clearly demarcated borders, which may have a fine overlying scale.
• Irritant dermatitis may occur due to soaps, nipple creams and other substances in direct contact with the breast.

In 2021 Amir et al (including myself) published a paper “Identifying the cause of breast and nipple pain during lactation” https://www.bmj.com/content/374/bmj.n1628

How can we treat nipple pain?

• In babies under 6 weeks assume, until proven otherwise by a breastfeeding expert, that it is due to less than perfect latch/attachment to the breast.
• If there is a white tip to the nipple after feeds optimise the attachment as this is likely to be vasospasm (temporary loss of blood supply to the nipple)
• Check for tongue tie by an expert trained to assess and treat appropriately. A tongue tie can result in the baby having a white tongue as milk does not reach the back of the tongue as it should.
• If the nipple is itchy after breastfeeds optimise attachment but if the nipple skin is dry and sore treat as a dermatitis with suitable moisturiser (does not need to be a specific product labelled to treat and prevent cracked nipples) and apply a smear of hydrocortisone 1% cream (or other low potency steroid) after feeds
• Frequent application of products sold to prevent and treat cracked nipples may contain lanolin and even highly purified forms can cause allergic reactions which increase itchy sensation.
• A mother may be allergic to anything which is in contact with her breasts during lactation as the environment around the nipple is more moist than usual – breast pads, washing powder, creams, soaps. These may produce a red circular area around the nipple.
• If nipple pain begins when the baby is teething, try to optimise latch and re-attach the baby/toddler if pain continues then apply a smear of hydrocortisone cream 1% after feeds to soothe inflammation and chaffing.
• If the mother has a history of poor circulation (usually Raynaud’s phenomenon) the use of nifedipine 10-20mg three times a day is effective. It is associated with side effects of headaches and/or hot flushes for the mother. If it has produced no improvement within 7 days discontinue and reconsider cause of pain. Research suggests that some mothers can stop treatment but still see resolution of symptoms. See https://breastfeeding-and-medication.co.uk/blog/february-is-raynaud-s-awareness-month-www-sruk-co-uk
• Look at other causes of pain by observing the mother and baby as a dyad and watching a complete feed from approach to the nipple to the baby coming off the breast unprompted. Does the baby have an asymmetrical latch? Does it suck the nipple into the mouth rather than having a wide gape? Does the mother take the nipple to the baby by leaning forward rather than lying back? Is the baby supported in the mother’s elbow?
• Is the pain in both breasts and is it the same after every feed?
• Is there a sloughy discharge in the crack suggesting a bacterial infection?
• Only after all these factors have been considered should a diagnosis of thrush be brought into the discussion. I believe thrush on the nipple is rare although it can occur. It should NEVER in my opinion, be the first treatment for sore nipples. A white tongue is not diagnostic of oral thrush nor is pain on one side.
• Paget’s disease can never be discounted as it presents as steadily progressing eczema.

Symptoms of nipple eczema(dermatitis)

Nipple eczema is characterised by redness, crusting, oozing, scales, fissure, blisters, excoriations or lichenification eczema (Core Curriculum for |Lactation Consultant Practice). It is often described by the mother as itching and is usually treated with topical steroids.

In Breastfeeding a Guide for the Medical Profession dermatitis is described as tender, burning, red fissures without exudate or itching, oozing with well-defined plaques. It has a recommendation by Alison Stuebe to culture for aerobic   bacteria and yeast. It differentiates between irritant and contact dermatitis.

Breastfeeding Management for the Clinician describes eczema as including erythema, papules, vesicles, oozing, lichenification, skin erosion, fissures, excoriations and scaling associated with itching which differentiates it to candidal infection. It cites Amir 1993 as recommending removal of the irritant and application of topical steroid (beclometasone 0.05%) with awareness that high colony Staph. Aureus may also be present and necessitate use of a topical antibiotic for example Mupirocin (Bactroban ™).

Barrett suggests that the application of topical steroids is the mainstay of treatment for eczema on the nipple and recommends a low or medium strength steroid applied twice a day for 2 weeks with anything residual being wiped off before a feed (not washed as it may further dry the skin of the nipple.

Barankin and Gross suggest that symptoms may appear after the introduction of some solids to the infant’s weaning diet. This can be ameliorated by rinsing the nipple with water or expressed breastmilk after feeds.

Anecdotally I have found that using a solution of 1 teaspoonful of bicarbonate of soda in a pint of water also helps assuming that it alters the pH of the skin transiently before application of the steroid. Please note that there is no published evidence for this, it is merely my experience of supporting breastfeeding mothers.

References

Amir L. Eczema of the Nipple and Breast: A Case Report. Journal of Human Lactation. 1993;9(3):173-175.

Barankin B, Gross MS. Nipple and Areolar Eczema in the Breastfeeding Woman. Journal of Cutaneous Medicine and Surgery. 2004;8(2):126-130.

Barrett ME, Heller MM, Fullerton Stone H, Murase JE. Dermatoses of the breast in lactation. Dermatol Ther. 2013 Jul-Aug;26(4):331-6. 

Core Curriculum for Lactation Consultant Practice International Lactation Consultant Association Eds Manuel R, Martens PJ, Walker M.  Jones and Bartlett

Douglas P. Re-thinking lactation-related nipple pain and damage. Womens Health (Lond). 2022 Jan-Dec; 18:17455057221087865.

Lawrence RA MD and Lawrence RM Breastfeeding a Guide for the Medical Profession. Elsevier.

Walker M Breastfeeding Management for the Clinician. Jones and Bartlett

Wambach K and Spencer B. Breastfeeding and Human Lactation. Jones and Bartlett

See also.

Thrush and Breastfeeding https://breastfeeding-and-medication.co.uk/fact-sheet/breastfeeding-and-thrush

What do mothers want healthcare professionals to know about breast and nipple pain in lactation https://breastfeeding-and-medication.co.uk/fact-sheet/what-do-mothers-want-healthcare-professionals-to-know-about-breast-and-nipple-pain-in-lactation

Recently there have been several questions on the use of Ivabradine in breastfeeding mothers with Postural tachycardia syndrome (POTS ) and I confess I know little about this condition so am simply compiling the information from other sources. https://www.nhs.uk/conditions/postural-tachycardia-syndrome/

“Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.

Ivabradine blocks the cyclic nucleotide-gated (HCN) channel responsible for the cardiac pacemaker . There are no data on its transfer of this drug into human milk, but the detrimental effects to the foetus are concerning which may carry on into early postpartum periods during breastfeeding. If used, close monitoring by a paediatric cardiologist is suggested.” Hale TW and Krutsch, K. Medications and Mothers Milk Springer Publ. accessed online 15.October 2024

It has a half life of 6 hours (Hale) but e-lactancia quotes 2 hours, but that of its active metabolite S18982 is 11 hours, plasma protein binding 70% but oral bioavailability only 40%

In a 2018 paper Kearney suggests that:

Its molecular weight (467) and protein binding (70 %) suggest that excretion into breast milk would be expected. However, ivabradine has low oral bioavailability (40 %) due to extensive first pass metabolism (Tse 2015). it is unclear what effect, if any, the potentially low levels in breast milk could have on the developing infant. Until more is known about ivabradine in breast milk, it must be used with extreme caution. The infant should be monitored for bradycardia and arrhythmias, and poor feeding and weight gain.

References

Hale TW and Krutsch, K. Medications and Mothers Milk Springer Publ.

Ivabradine and breastfeeding. Are they compatible? (e-lactancia.org)

Choi HY, Noh YH, Cho SH, Ghim JL, Choe S, Kim UJ, Ah Jung J, Bae KS, Lim HS. Evaluation of pharmacokinetic and pharmacodynamic profiles and tolerability after single (2.5, 5, or 10 mg) and repeated (2.5, 5, or 10 mg bid for 4.5 days) oral administration of ivabradine in healthy male Korean volunteers. Clin Ther. 2013 Jun;35(6):819-35.

Kearney L, Wright P, Fhadil S, Thomas M. Postpartum Cardiomyopathy and Considerations for Breastfeeding. Card Fail Rev. 2018

Tse S, Mazzola N. Ivabradine (Corlanor) for Heart Failure: The First Selective and Specific I f Inhibitor. P T. 2015 Dec;40(12):810-4.

A tattoo involves injecting an ink into the dermis of the skin. Worldwide 10-20% of the population is tattooed (https://pubmed.ncbi.nlm.nih.gov/34605159/) but there is little research on the effects of the inks. The most common reactions are allergies particularly to red ink and infections (https://pubmed.ncbi.nlm.nih.gov/34969030/). Most of the ink stays fixed in the area to which it is injected but some of the ink is transported away from the skin via the vasculature or lymphatic system; it will end up in other organs or will be excreted. Coloured lymph nodes near tattooed areas have been known. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5400116/).

Tattoo artists use a hand-held electric machine that is fitted with solid needles coated in the ink to pierce the skin to a depth of a few millimeters. Tattoo ink is assumed to be too large to pass into breast milk, so the baby is not exposed to it.

It is important to choose a tattoo artist with clear hygiene precautions to minimise risk of infection. Many studios will refuse to perform a tattoo on a breastfeeding mother because of public liability and insurance. Many councils stipulate this as a criteria of licensing premises. This largely goes back to the AIDS epidemic and the risk of transferring the HIV virus through blood contamination.

Professional tattoo artists should follow standard hygiene precautions such as sterilization of the tattoo machine using an autoclave, single-use inks, ink cups, gloves and needles, bagging of equipment to avoid cross contamination, and thorough hand washing with disinfectant soap. Anaesthetic creams applied topically before the tattoo such as EMLA cream ™ are compatible with breastfeeding.

The decision to proceed should be an informed decision by the person choosing to have this body art.

Other sources of information

La Leche League International https://llli.org/breastfeeding-info/tattoos-and-breastfeeding/

E-lactancia Tattoo https://e-lactancia.org/breastfeeding/tattoo/product/

LactMed Tattooing https://www.ncbi.nlm.nih.gov/books/NBK500563/

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

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

1. If a breastfeeding mother has raised cholesterol (not familial) encourage diet and lifestyle changes and monitor at intervals
2. 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)
3. Standard Infant formula contains no cholesterol (Lawrence) but also lacks the cardio protective properties of breastmilk (Tschiderer)
4. 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

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/