The reason I write these factsheets is in response to the questions which are posed to me on social media. I have included the use of midazolam in fact sheets on colonoscopy, endoscopy and dental sedation on information on the Breastfeeding Network but still mothers are told that they need to delay procedures, are only allowed gas and air during the procedure or must stop breastfeeding for 24 hours. The latter is recommended by the manufacturers but since the half life is 3 hours it is all gone from the mother’s body and therefore her milk within 15 hours. Those 9 hours make a massive difference to a breastfeeding dyad which seems to be ignored by the professional
This factsheet contains information taken from my book Breastfeeding and Medication 2018. I hope it helps breastfeeding mums and professionals
It is surprising how often mums manage to take products containing aspirin by mistake – they are given by well meaning partners, friends at the office or just taken quickly for pain. Then the realisation that aspirin is contra indicated in breastfeeding. What to do? How long to express?
The answer is actually simple with one single accidental exposure. The risk is low and I have been unable to find any references associating Reye’s syndrome with the amount of aspirin passing through breastmilk.
Reye’s syndrome This is a rare syndrome, characterised by acute encephalopathy and fatty degeneration of the liver, usually after a viral illness or chickenpox. The incidence is falling but sporadic cases are still reported. It was often associated with the use of aspirin during the prodromal illness. Few cases occur in white children under 1 year although it is more common in black infants in this age group. Many children retrospectively examined show an underlying inborn error of metabolism.
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One of the hardest questions I have to answer. I want to help but I need to keep the breastfed baby safe too
Avoid if possible. Use for as short a time as possible. Observe baby for drowsiness. Avoid falling asleep with the baby in bed, on a chair or sofa
Committee on Safety of Medicines advice
1 Benzodiazepines are indicated for the short-term relief (two to four weeks only) of anxiety that is severe, disabling or subjects the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness.
2 The use of benzodiazepines to treat short-term ‘mild’ anxiety is inappropriate and unsuitable.
3 Benzodiazepines should be used to treat insomnia only when it is severe, disabling, or the individual is caused extreme distress.
Bisoprolol use seems to be increasing from the queries I receive. It is difficult to assess safety as published information relies on one study where the level in milk was undetectable BUT the baby was not given any of its mother’s milk. If other beta blockers are not suitable then the baby should be monitored closely for side effects and particularly hypo-glycaemia if newborn.
BNF ” With systemic use in the mother, infants should be monitored as there is a risk of possible toxicity due to beta-blockade. However, the amount of most beta-blockers present in milk is too small to affect infants.”
Use labetolol, metoprolol or propranolol as alternative if possible, especially in neonates. But with older babies theoretical risk is low from one single case study where levels were undetectable
Bisoprolol is a beta blocker used to treat hypertension and is particularly used where there are cardiac issues. It may be used to prevent future heart disease, heart attacks and strokes or to treat irregularities of heart beat. Sometimes it is not possible to replace it with beta blockers on which we have more information in lactation e.g.propranolol , labetolol or metoprolol.
Hypogycaemia in the neo natal period
In many maternity units the use of beta blockers triggers the hypoglycaemia policy involving blood sugar testing. The amount of labetolol, propranolol and metoprolol passing into breastmilk is low and these drugs are less likely to lower blood sugars than atenolol (which has low plasma protein binding and passes more extensively into milk). The risk to the baby stems from the fact that babies born to mothers with pre-eclampsia may be born (or induced) early or may have experienced intra-uterine growth retardation. The efficacy of the baby’s feeding and milk transfer should be assessed as well as blood sugars. If necessary the mother may need to hand express and syringe/cup/spoonfeed colostrum to her infant.
Many mothers with pre-existing conditions are taking bisoprolol throughout pregnancy. Bisoprolol has 30% protein binding and a half-life of 9–12 hours, so it presents a moderately high risk for accumulation in infants, especially neonates. Only one study seems to exist where a mother delivered at 36 weeks’ gestation following major cardiac abnormalities. From day nine she expressed daily for six days. Her milk was analysed for bisoprolol. It was undetectable (<1 mcg/L) in all samples but the baby remained exclusively artificially fed.
Bisoprolol in lactation (Brand name: Cardicor®, Emcor®)
Only one study of the use of bisoprolol appears in the literature. Khurana et al. (2014) studied a mother who was initiated on it six days after birth for a cardiac condition. She expressed samples of milk on day 11 and 18 after birth. Drug levels in milk were undetectable but the baby did not receive any breastmilk so data is incomplete.
Bisoprolol is almost completely absorbed from the GI tract and undergoes only minimal first-pass metabolism resulting in an oral bio-availability of approximately 90%. It is 30% plasma protein bound. It is a cardio-selective beta blocker. Its pharmacokinetic properties suggest that it may accumulate particularly in neonates and its use should be avoided unless essential. Other beta blockers demonstrate better safety data in lactation.
The BNF recommends that the amount of most beta blockers in breastmilk is probably too small to be harmful although it is advisable to monitor the infant for possible symptoms of beta-blockade.
Use labetolol, metoprolol or propranolol as alternative if possible, especially in neonates
• Baby Friendly Initiative, Hypoglycaemia Policy Guidelines, UNICEF UK.
• British Association of Perinatal Medicine, Identification and Management of Neonatal Hypoglycaemia in the Full-Term Infant – A Framework for Practice, April 2017, www.bapm.org/resources.
• Khurana R, Bin Jardan YA, Wilkie J, Brocks DR, Breast milk concentrations of amiodarone, desethylamiodarone, and bisoprolol following short-term drug exposure: two case reports, J Clin Pharmacol, 2014;54:828–31.
That new title is going to take a lot of getting used to! I am very proud and delighted to have been nominated for an MBE for services to mothers and babies as a founder of the Breastfeeding Network Drugs in Breastmilk Service. I never thought this would happen to me following a path which I didnt really plan 22 years ago but has led me to this amazing place. I feel inspired to keep going and hopefully change some more professional attitudes that prescribing a medication doesnt mean that a mother needs to interrupt breastfeeding. Thank you to the many, many people who have sent messages of congratulations today – I appreciate them so much.
I also want to thank my wonderful family for their support – my husband Mike, my daughters Kerensa, Bethany and Tara, my son in laws Christian, Steve, Rich and Ian and of course my treasured grandchildren Stirling, Isaac, Beatrix and Elodie and the new bump due in 2019. I cant tell you how much I love you all
In a report today Public Health England have made recommendations on dental health and breastfeeding. Full information can be accessed at : www.gov.uk/government/publications/breastfeeding-and-dental-health/breastfeeding-and-dental-health#breastfeeding-and-dental-health
- dental teams should continue to support and encourage mothers to breastfeed
- not being breastfed is associated with an increased risk of infectious morbidity (for example gastroenteritis, respiratory infections, middle-ear infections)
- breastfeeding up to 12 months of age is associated with a decreased risk of tooth decay
- breast milk is the only food or drink babies need for around the first 6 months of their life, first formula milk is the only suitable alternative to breast milk
- bottle-fed babies should be introduced to drinking from a free-flow cup from the age of 6 months and bottle feeding should be discouraged from 12 months old
- only breast or formula milk or cooled, boiled water should be given in bottles
- only milk or water should be drunk between meals and adding sugar to foods or drinks should be avoided
Recent systematic reviews such as that by Tham and others (2015)6 included studies where children were breastfed beyond 12 months. When infants are no longer exclusively breast or formula fed, confounding factors, such as the consumption of potentially cariogenic drinks and foods and tooth brushing practices (with fluoride toothpaste), need to be taken into account when investigating the impact of infant feeding practices on caries development. Tham and others (2015) noted that several of the studies did not consider these factors and concluded that with regard to associations between breastfeeding over 12 months and dental caries “further research with careful control of pertinent confounding factors is needed to elucidate this issue and better inform infant feeding guidelines”. Good quality evidence on breastfeeding and oral health is an area with significant methodological challenges which have been outlined by Peres and others (2018)7.
Of course I would also have to highlight that dental procedures, including sedation, local and general anaesthetic and use of antibiotics and analgesics need not interrupt breastfeeding
We all know as parents how hard it is to comfort a baby who is teething and to witness their distress. As a pharmacist, mother and grandmother I know that the standard products often recommended in the past contained a local anaesthetic often lidocaine.
In 2014 the FDA in USA first raised concerns stating that “Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes, and they can be harmful”.
Today the MHRA have announced that parents and caregivers are being advised that products containing lidocaine used for teething in babies and children will be sold only in pharmacies, under the supervision of a pharmacist from the beginning of 2019. The MHRA review concluded there is a lack of evidence of benefit to using products containing lidocaine for teething before non-medicinal options. Evidence of any risk associated with these products is very small given the wide usage of these medicines. A pharmacist or healthcare professional can provide appropriate guidance. Teething is a natural process and lidocaine containing teething products such as teething gels should only be used as a second line of treatment after discussion with and guidance of a healthcare professional.
It is suggested that parents try non-medicine options such as rubbing or massaging the gums or a teething ring before considering teething gels after discussion with a pharmacist.
Further information can be found :
And a patient information leaflet: https://assets.publishing.service.gov.uk/media/5c0fd7cbed915d0c736a1e64/Lidocaine-patient-sheet.pdf
La Leche League GB have produced an excellent article on teething which can be accessed www.laleche.org.uk/breastfeeding-and-teething/#Pain.
The NHS also has sound information: https://www.nhs.uk/conditions/pregnancy-and-baby/teething-tips/
Products include Dentinox gel ®, Calgel ®, Bonjela ®, Anbesol gel ®
MBRRACE–UK released their 5th report ‘Saving Lives, Improving Mothers’ Care’. It describes the lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity from 2014-2016. Here’s The Breastfeeding Network’s response.
The Breastfeeding Network (BfN) welcomes the report. While the research has found that the number of women dying as a consequence of complications during or after pregnancy remains low in the UK – with fewer than 10 out of every 100,000 pregnant women dying in pregnancy or around childbirth, the report highlights the unacceptable disparity in care for black and ethnic minority women. Shereen Fisher, Chief Executive for the Breastfeeding Network said, ‘The almost five-fold higher mortality rate amongst black women compared with white women requires urgent explanation and action. BfN welcome further exploration into this unacceptable disparity to ensure there is real change for black and ethnic minority women’.
A key concern, is the tragic case of a mother dying several weeks after her baby was born (Commencing treatment, dose and compliance page 39). There were delays in prescribing thromboprophylaxis because of concerns over breastfeeding.
Dr Wendy Jones, lead pharmacist for the BfN Drugs in Breastmilk Information service, said ‘I have long feared such a scenario. Physicians need to be aware how to check that a drug treatment is compatible with breastfeeding quickly, using evidence-based sources. The drugs in this case are widely used in the immediate postnatal period yet emergency medicine teams are often unable to access readily available evidence-based information on medication and breastfeeding as quickly as they need. The information should have been readily available in guidelines or a reference source including specialist information. The wording of the BNF: “Due to the relatively high molecular weight and inactivation in the gastro-intestinal tract, passage into breast-milk and absorption by the nursing infant are likely to be negligible, however manufacturers advise avoid” needs to be updated where the manufacturer is merely not taking responsibility in licensing the product. The removal of the words “manufacturer advises avoid” makes the information read very differently to a busy practitioner’.
Shereen Fisher, Chief Executive for the Breastfeeding Network said, ‘This sad case highlights the need for mothers to be able to access skilled support in their local communities, with staff alert for symptoms needing attention; the mother in question had multiple ‘fainting’ episodes postnatally that were not investigated until day 44. This emphasises the need for health care professionals in all front-line services to understand how to treat pregnant and breastfeeding mothers – until this happens women will continue to be exposed to risk and potentially loss of life. It feels that no-one listened to the mother or observed her and her baby as a dyad as closely as they should have done, possibly because breastfeeding was seen as a barrier to medication. Women should not be disadvantaged in the management of acute illness just because they are pregnant or breastfeeding, and communication needs to be improved throughout the multidisciplinary team.’
To read more you can download the full report, lay summary and the infographic here: https://www.npeu.ox.ac.uk/mbrrace-uk/reports