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 ®