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.

accidental/one off dose of aspirin factsheet

Aspirin is not generally recommended to be used by lactating women due to the link between aspirin and Reye’s syndrome. Aspirin is 80–90% bound to plasma proteins. Erickson and Oppenheim (1979) found that even at a dose of 4 g per day the levels of salicylate measured in one mother suffering from rheumatoid arthritis were below the level of detection. Findlay et al. (1981) studied two mothers exposed to 454 mg aspirin. They found that salicylic acid penetrated poorly into milk, with peak levels of only 1.12–1.60 µg per millilitre, and estimated that about 0.1% of the mothers’ total dose would appear in breastmilk.

Accidental consumption of a single dose of aspirin by a lactating mother need not lead to expressing and discarding of her breastmilk. Theoretical infant dose through breastmilk is quoted as 0.25 mg per kilogramme per day with a relative infant dose quoted as 2.5–10.8% (Hale 2017 online access).

The BNF states: ‘Avoid – possible risk of Reye’s syndrome; regular use of high doses could impair platelet function and produce hypoprothrombinaemia in infant if neonatal vitamin K stores low’. Vitamin K is secreted in breastmilk and is added to formula.

If taken accidentally no evidence that continuing to breastfeed after single dose is harmful.

References

Erickson SH, Oppenheim GL, Aspirin in breastmilk, J Fam Pract, 1979;8(1):189–90.

Findlay JW, DeAngelis RL, Kearney MF, Welch RM, Findlay J, Analgesic drugs in breastmilk and plasma, Clin Pharmacol Ther, 1981;29:625–33.

Glasgow JF, Reye’s syndrome: the case for a causal link with aspirin, Drug Saf, 2006;29(12): 1111–21.

---

Leave a comment

Logged in as Wendy Jones. Log out?

Comment

Follow us

Information taken from Breastfeeding and Chronic Medical Conditions available from Amazon

“in the early stages when getting used to feeding I found I had to keep snacks handy to avoid having hypos but apart from that everything went well. I had to be determined due to the added energy being used and the normal fatigue I get but having hoped to get to 6 weeks we’re now 24 months and still feeding.”

Description

Type 1 diabetes usually first develops in children or young adults. In the UK about 1 in 300 people develop type 1 diabetes at some stage. Itusually develops quite quickly, over days or weeks. Type 1 diabetes is an auto-immune disease caused by the destruction of the insulin producing beta cells in the pancreas. There is a genetic component in the development, but it is triggered by environmental factors such as early introduction of cow’s milk protein, viral infections, and exposure to toxins.

Symptoms of type 1 diabetes are excessive thirst, frequent passing of urine, extreme tiredness, and dramatic weight loss. Untreated or poorly controlled diabetes leads to damage to the eyes, feet, nerves, kidneys, and increased risk of coronary heart disease. With treatment and monitoring these effects can be minimised.

If insulin levels are unstable in pregnancy the baby may be born large for dates. Miscarriage, pre‑eclampsia and preterm labour are more common in women with pre‑existing diabetes. Folic acid supplements 5mg a day should be taken before conception and for the first 3 months of pregnancy.

Mothers with Type 1 diabetes are less likely to breastfeed (77% vs 86%) and those who do continue for a shorter duration (12 vs 17 weeks) (Hummel 2007). Fasting blood sugars are lower during exclusive breastfeeding. Milk production may be limited with unstable insulin levels. There is a period of hypoglycaemia after delivery following which Insulin requirements may be reduced by 27% (Davies 1989), In another study (Whichelow 1983) diabetic mothers increased their carbohydrate intake by 50g whilst breastfeeding whilst requiring 40 units insulin compared with 45 units pre-pregnancy. Immediately after delivery carbohydrate snacks should be available and glucose tablets to counteract any hypoglycaemia. Mothers should be reminded to have snacks available during night-time feeds and to monitor blood glucose levels if necessary, in order to adjust insulin requirements

Alves (2012) studied 123 children with type 1 diabetes and their siblings as case controls. Whilst there was no difference between breastfeeding, those children with type 1 diabetes were breastfed for a shorter time (3.3 vs 4.6 months) and were exposed to cow’s milk earlier than their siblings.

Mothers with diabetes are at risk of developing pre-eclampsia and should take 75 mg aspirin daily from 12 weeks’ pregnancy until delivery. Infants born to diabetic mothers have a 25–40% incidence of hypoglycaemia in the first one to two hours after delivery (Chertok 2009). This is transient and resolves spontaneously. Mothers with diabetes may have delayed lactogenesis II.  Perez-Bravo et al. (1996) suggested that the risk of a child developing diabetes is 13 times higher if a susceptible infant is exposed to cow’s milk protein in the first three–four hours after delivery. The DAME (Diabetes and Antenatal Milk Expressing 2017) study provided evidence that providing the baby with previously expressed and stored colostrum rather than infant formula or oral glucose did not increase the risk of admission to NICU and is therefore preferable. This is also true for mothers with gestational diabetes or type 2 diabetes managed by insulin in pregnancy.

Treatment

Insulin is safe for use by breastfeeding mothers as the molecule is too large to pass into breastmilk (molecular weight > 6000). It has no hypoglycaemic effect from oral absorption as it is inactivated in the gastrointestinal tract. Thus, it would not be expected to exert any action on the infant’s glycaemic control. Breastfeeding may lower a woman’s insulin requirements by up to 30%. To prevent hypoglycaemic attacks, mothers may need to increase their carbohydrate intake or decrease their insulin dose.

During pregnancy and breastfeeding, insulin requirements may be altered, and doses should be assessed frequently by an experienced diabetes physician as well as by regular monitoring. The dose of insulin generally needs to be increased in the second and third trimesters of pregnancy.

References

• Alves JG, Figueiroa JN, Meneses J, Alves GV. Breastfeeding protects against type 1 diabetes mellitus: a case-sibling study. Breastfeed Med. 2012 Feb;7(1):25-8
• Chertok IRA, Raz I, Shoham I et al Effects of early breastfeeding on neonatal glucose levels of term infants born to women with gestational diabetes. J Hum Nutr Diet 2009;22(2): 166-9
• Davies RR, McEwen J, Moreland TA, Durnin C, Newton RW. Improvement in morning hyperglycaemia with basal human ultratard and prandial human actrapid insulin–a comparison of injection regimens. Diabetic Medicine 1988; 5:671-5.
• Foster, DA, et al (2017), Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial. The Lancet, DOI: http://dx.doi.org/10.1016/S0140-6736(17)31373-9
• Pérez-Bravo F, Carrasco E, Gutierrez-López MD, Martínez MT, López G, García de los Rios M, Genetic predisposition and environmental factors leading to the development of insulin-dependent diabetes mellitus in Chilean children, J Mol Med, 1996;74(2):105–9.
• S. Hummel C. Winkler S. Schoen A. Knopff S. Marienfeld E. Bonifacio A. G. Ziegler. Breastfeeding habits in families with Type 1 diabetes. Diabetic Med. 2007; 24 (6): 671-676
• Whichelow MJ, Doddridge MC. Lactation in diabetic women. Br Med J (Clin Res Ed) 1983;3;287(6393):649–650.

Information taken from Breastfeeding and Chronic Medical Conditions available from Amazon

Type 2 diabetes develops over weeks and months rather than suddenly as type 1 diabetes does. It is estimated that 415 million people across the world are living with diabetes, approximately 1 in 11 of the world’s adult population. Type 2 diabetes is now becoming far more common in children and in young people. The number of people of any age with type 2 diabetes is increasing in the UK, as it is more common in people who are overweight or obese. It also tends to run in families. It is around five times more common in South Asian and African-Caribbean people (often developing before the age of 40 in this group). It is estimated that there are around 750,000 people in the UK with type 2 diabetes who have not yet been diagnosed with the condition.

Gunderson (2018) showed that increasing lactation duration was associated with a strong, graded relative reduction in the incidence of type-2 diabetes even after accounting for pre-pregnancy biochemical measures, clinical and demographic risk factors, gestational diabetes, lifestyle behaviours, and weight gain. The graded risk reduction ranged from 25% for 6 months or less to 47% for 6 or more months of lactation. Shwarz (2009) had previously demonstrated that women who reported a lifetime history of more than 12 months of lactation were 10-15% less likely to have hypertension, diabetes, hyperlipidaemia, and cardiovascular disease than those who had not breastfed. Breastfeeding could be said to be a positive health intervention based on these results.

Type 2 diabetes has symptoms like excessive thirst (often drinking considerable amounts of fruit squashes), needing to pass urine frequently and tiredness particularly after meals. Early symptoms of high glucose levels can be reversed by diet and exercise. At any stage lifestyle interventions can prevent further development and reverse the diagnosis.

Risk factors for type 2 diabetes are:

• Having a first-degree relative with type 2 diabetes.
• Being overweight or obese.
• Having a waist measuring more than 31.5 inches (80 cm) if you are a woman or more than 37 inches (94 cm) if you are a man. Central obesity occurs because of the effect of insulin pushing excess sugar into abdominal fat cells over the years.
• Having impaired glucose tolerance.
•  Having gestational diabetes

Treatment

Non-insulin dependent diabetes (type 2 diabetes) treatment can be commenced with metformin, if dietary modification alone has not produced glycaemic control. There were no reported adverse effects on the babies in the published studies including effect on baby’s blood sugar.There is no data on any of the other oral drugs used to treat diabetes which should therefore be avoided. If metformin does not achieve control of blood sugars a breastfeeding mother may need to initiate insulin for the duration of her lactation.                                                                                        

Sulfonylureas be avoided during breastfeeding as they may produce hypoglycaemia in breastfed infant; Glibenclamide, Gliclazide, Glimepiride, Glipizide, Tolbutamide

There is no data on any of the other oral drugs used to treat diabetes which should therefore be avoided. If metformin does not achieve control of blood sugars a breastfeeding mother may need to initiate insulin for the duration of her lactation.

Dipeptidyl peptidase – 4 – inhibitors (Gliptins): Alogliptin, Linagliptin, Saxagliptin, Vildagliptin

  Glucagon-like peptide1 receptor agonists: Albiglutide, Dulaglutide, Exanatide, Liraglutide, Lixisenatide

Meglitinides: Nateglinide, Repaglinide

Thioglitazones: Pioglitazone

References

• Gunderson EP, Hurston SR, Ning X, Lo JC, Crites Y, Walton D, Dewey KG, Azevedo RA, Young S, Fox G, Elmasian CC, Salvador N, Lum M, Sternfeld B, Quesenberry CP Jr; Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy Investigators. Lactation and Progression to Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus: A Prospective Cohort Study. Ann Intern Med. 2015 Dec 15;163(12):889-98)
• Schwarz EB, Brown JS, Creasman JM, et al. Lactation and maternal risk of type 2 diabetes: a population-based study [published correction appears in Am J Med. 2011 Oct;124(10): e9]. Am J Med. 2010;123(9):863.

Information taken from Breastfeeding and Chronic Medical Conditions available on Amazon.

Gestational Diabetes is described as impaired glucose tolerance in pregnancy. It is also increasing in prevalence due to obesity rates and now affects some 7% of pregnancies. Most women will need oral metformin to reduce blood glucose or insulin if changes in diet and exercise do not control gestational diabetes effectively. Risk factors for gestational diabetes are.

•             BMI above 30 kg/m2

•             previous macrosomic baby weighing 4.5 kg or above

•             previous gestational diabetes

•             family history of diabetes (first‑degree relative with diabetes

•             minority ethnic family origin with a high prevalence of diabetes.

Kjos (1993) recommended that delivery should be contemplated at 38 weeks and, if not pursued, careful monitoring of foetal growth should be performed to reduce the risk of large for gestational age babies and shoulder dystocia.

Medication is normally discontinued after delivery although a proportion of mothers will go on to develop Type 2 diabetes. Women with gestational diabetes who do not breastfeed are twice as likely to develop future diabetes (Kjos 1993).

Gunderson (2012) studied 522 women diagnosed with gestational diabetes 6-9 weeks after delivery. Exclusive or mostly breastfeeding was associated with improved fasting glucose and lower insulin levels at this time. Lactation was seen to have favourable effects on glucose metabolism and insulin sensitivity that may reduce the risk of diabetes after delivery. These findings continued for 2 years after delivery (Gunderson 2015).

Infants born to diabetic mothers have a 25-40% incidence of hypoglycaemia in the first one to two hours after delivery. This is transient and resolves spontaneously.  Mothers with diabetes have delayed lactogenesis 2. This raises the risk if babies being supplemented which as Perez-Bravo reported increases the risk of future diabetes for the baby. To reduce the risk, it has become increasingly common to suggest that mothers express and store colostrum from 36 weeks gestation. The DAME trial studied 635 women with diabetes. The primary outcome of the trial was the proportion of infants admitted to the NICU post-natally. The results showed that there was no difference between groups (antenatal expression or normal care). They concluded that there was no harm in encouraging antenatal expression of colostrum twice a day in mothers with uncomplicated pregnancies.

References

• Brown A. Jones W A guide to supporting breastfeeding for professionals. Routledge 2019
• Davies HA, Clark J. D., Dalton K. J., and Edwards O. M.    Insulin requirements of diabetic women who breast feed. BMJ. 1989 May 20; 298(6684): 1357–1358.
• Forster, D A,  Moorhead AM, Jacobs SE, , Davis PG, Walker SP, McEgan KM, Opie GF, Donath SM, Gold L, McNamara C,  Aylward A, East C,  Ford R, Amir LH, Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial. The Lancet 2017;389: 2204 – 2213
• Gunderson EP, Hedderson MM, Chiang V, Crites Y, Walton D, Azevedo RA, Fox G, Elmasian C, Young S, Salvador N, Lum M, Quesenberry CP, Lo JC, Sternfeld B, Ferrara A, Selby JV. Lactation intensity and postpartum maternal glucose tolerance and insulin resistance in women with recent GDM: the SWIFT cohort. Diabetes Care. 2012 Jan;35(1):50-6.
• Hummel S Winkler C, Schoen S, Knopff A, Marienfeld S, Bonifacio E, Ziegler AG. Breastfeeding habits in families with Type 1 diabetes. Diabet Med. 2007 Jun;24(6):671-6
• Jones W Breastfeeding and Medication 2nd Ed 2018 Routledge UK
• Kjos SL, Henry OA, Montoro M, Buchanan TA, Mestman JH. Insulin-requiring diabetes in pregnancy: a randomized trial of active induction of labour and expectant management. Am J Obstet Gynecol. 1993 Sep;169(3):611-5.
• Liu B, Jorm L, Banks E Parity, breastfeeding, and the subsequent risk of maternal type 2 diabetes. Diabetes Care, 2010; 33(6): 1239-41.
• Milne N Managing diabetes in women during preconception and pregnancy Clinical Pharmacist 2017; 9 (9)
• NICE Diabetes in pregnancy: management from preconception to the postnatal period NG3
• NICE Hypertension in pregnancy: diagnosis and management CG107
• Pérez-Bravo F. Carrasco E Gutierrez-López M. D. Martínez M. T. López G. García de los Rios M.  Genetic predisposition and environmental factors leading to the development of insulin-dependent diabetes mellitus in Chilean children Journal of Molecular Medicine 1996;74(2):105-109
• Whichelow MJ, Doddridge MC. Lactation in diabetic women. Br Med J (Clin Res Ed) 1983; 3;287(6393):649–650).

Interestingly I am getting more reports of mums who have taken codeine accidentally – having opened the wrong packet, or been given it by supportive partners or relatives and friends. They are terrified that they have to stop breastfeeding and ask for how long they need to pump and dump their milk (such a terrible risk of liquid gold!). Here is the answer!

Accidental codeine / one dose and breastfeeding factsheet

Codeine is no longer recommended for breastfeeding mothers following recommendations by MHRA in 2016 . However, it seems that many women are prescribed codeine by GPs or discharged with it from secondary care with instructions not to breastfeed the baby. Until the baby in Canada died (ref) we routinely used co-codamol for all post-natal mothers.

 Not everyone has the metabolism which concentrates the drug and its metabolites into milk. For them the drug is effective and neither they nor their babies exhibit side effects. For others, including my own family, codeine makes us feel sick and dizzy. It also seems to cause drowsiness in my breastfed grandchildren so that they sleep longer and more frequently if their mothers take it.

Accidental consumption of a single dose of codeine by a lactating mother need not lead to expressing and discarding of her breastmilk if her baby is term, fit and well. She should observe the baby for signs of drowsiness and if that happens make sure the co-codamol is kept out of the way in the future. But no need to panic and no need to stop breastfeeding for a single dose unless the baby develops breathing problems.

In answer to the queries it takes 15 hours for all the codeine to be removed from the body including milk.

So many mums seem to injure their backs – maybe we need antenatal classes on how to lift your baby (and equipment!) or more assessment of post-natal damage. When pain has not resolved with simple painkillers (paracetamol and ibuprofen (taken regularly and at full dose) sometimes further treatment is necessary from professionals. This may help the mother access physiotherapy or other mobility treatment.

Information here on how to treat the pain of acute back injury and relieve the spasm. I hope that it aids mothers and professionals.

Breastfeeding and pain relief for acute back injury

Non- steroidal analgesia

Normally mothers have taken ibuprofen along with paracetamol and may have found the pain has not resolved. I would suggest changing ibuprofen to naproxen or diclofenac to see if that helps. Both are compatible with breastfeeding. They should be taken with food and may be co-prescribed with omeprazole to protect the mother’s stomach from gastric bleed. The omeprazole is largely destroyed in the maternal gut and does not impact on breastfeeding.

Muscle spasm

Muscle spasm relief can be achieved by the use of cold packs or heat packs. Topical rubs containing NSAIDS (Volatrol ®, Ibuleve®, PhorPain ®, Fenbid® etc) can be used with paracetamol. Ribs which produce warming or cooling can also provide relief along with massage to the area (Deep Heat ®, Tiger Balm®, Algesal® etc)

Up to a maximum of three days of diazepam 2mg 2-3 times a day to relive the spasm is also regularly used. It doesn’t seem to cause any problems used short term like this despite the long half-life. This is normally long enough to access some physio or other exercise regime. The evidence for this is largely anecdotal and based on my professional experience over the past 20 years. (Hale TW Medications and Mother’s Milk “Some reports of lethargy, sedation, and poor suckling have been found. The acute use such as in surgical procedures is not likely to lead to significant accumulation.”

Opiate pain relief

If greater pain relief is required, tramadol, Oramorph or dihydrocodeine are all breastfeeding compatible options.

• Dihydrocodeine or co dydramol is widely used post c section and is now the opiate analgesic of choice due to the fact that it has a cleaner metabolism.
• Morphine has extensive first pass metabolism so actually reaches low levels in milk. Oramorph is widely used
• Tramadol reaches low levels in babies but can make mum very sleepy. Watch the baby for signs of drowsiness too.

Constipation

If you take co-dydramol or oramorph or any opioid you will need a laxative like lactulose, bisacodyl or dioctyl all of which you can buy from a pharmacy, See https://breastfeeding-and-medication.co.uk/fact-sheet/constipation-laxatives-and-breastfeeding

The following data is extracted from my book Breastfeeding and Medication 2018

Co-dydramol – paracetamol 500 mg and dihydrocodeine 10 mg.

Preferred compound analgesic due to cleaner metabolism than codeine. Use for as short a time as possible. Observe baby for drowsiness. If baby becomes drowsy stop drug immediately and seek medical advice.

Tramadol

Tramadol is an opiate analgesic used for moderate to severe pain. Its use would appear to have increased as a result of concern over codeine preparations. It is subject to first-pass metabolism. It has an elimination half-life of six hours. Tramadol inhibits the reuptake of noradrenaline and serotonin and may potentiate the action of other drugs with similar action, e.g. SSRI anti-depressants.

Ilett et al. (2008) studied 75 breastfeeding mothers who were given 100 mg tramadol post-caesarean section on days two–four. They collected milk and plasma samples of four or more doses to reflect steady state. Additionally, he observed the infants together with matched controls not exposed to tramadol. He determined a relative infant dose quoted as 2.24% for tramadol and 0.64% for its metabolite. No difference was noted in the behaviours of the infants exposed compared with the controls and the authors therefore concluded that short-term maternal use of tramadol is compatible with breastfeeding.

In 2015 the FDA recommended that tramadol is not used in breastfeeding mothers. When tramadol is taken, it is changed in the liver to O-desmethyltramadol (known as M1). Both tramadol and M1 relieve pain and are responsible for side effects that some people may experience, but M1 has stronger opioid effects than the tramadol. Tramadol is metabolised in the liver by enzyme cytochrome P450 isoenzyme 2D6 (CYP2D6). Some people have a variation of this enzyme that changes codeine to morphine and tramadol to M1 faster and to a greater extent than in other people. These individuals are called CYP2D6 ultra-rapid metabolisers. Just as in codeine, this can produce an accumulation of the drug in breastmilk. This genotype is present in up to 10% of the white population in Europe and North America, but only 4% of black African Americans (FDA 2015).

As with other opiates, exposure of premature infants should be undertaken with caution because of the risk of apnoea and sedation. Amount probably too small to be harmful, but manufacturer advises avoidance (BNF).

Avoid if possible although the amount in breastmilk is probably too small to be harmful. Use for as short a time as possible. Observe baby for drowsiness. If baby becomes drowsy stop drug immediately and seek medical advice.

• FDA, Use of Codeine and Tramadol Products in Breastfeeding Women, FDA, 2015.
• Ilett KF, Paech MJ, Page-Sharp M, Sy SK, Kristensen JH, Goy R, Chua S, Christmas T, Scott KL, Use of a sparse sampling study design to assess transfer of tramadol and its o-desmethyl metabolite into transitional breastmilk, Br J Clin Pharmacol, 2008;65(5):661–6.

Morphine

Therapeutic doses of morphine in the breastfeeding mother are unlikely to be harmful to baby in the short term, e.g. post-operatively. Infants under 4 weeks of age have a prolonged elimination half-life and clearance does not approach adult levels until 2 months of age. Respiratory difficulties may be important to be aware of with premature babies or others at risk of apnoea. The oral absorption of morphine is very poor and first-pass metabolism is high. It is therefore frequently used post-caesarean section as Oramorph solution.

Robieux et al. (1990) reported a single case of an infant who was breastfed while his mother was receiving low doses of morphine. Morphine concentration in his serum was in the analgesic range (4 ng per millilitre), while concentrations in the milk varied substantially from 10–100 ng per millilitre. The authors calculated that the baby had received 0.8–12% of the maternal dose. Oberlander et al. (2000) studied one baby born to a mother who received morphine intrathecally during and after pregnancy. Minimal levels were determined in breastmilk over seven weeks and the infant’s development and feeding up to seven months were normal. Baka et al. (2002) also studied women receiving patient-controlled analgesia post-caesarean section and noted that the concentrations of morphine in breastmilk were very small (<1 to 274 ng per millilitre) with a m/p ratio <1. Relative infant dose is quoted as 9.1% (Hale 2017 online access). Therapeutic doses unlikely to affect infant (BNF).

Compatible with use short term during breastfeeding. Observe baby for sedation and poor feeding.

References

• Baka NE, Bayoumeu F, Boutroy MJ, Lexenaire MC, Colostrum morphine concentrations during postcesarean intravenous patient-controlled analgesia, Anesth Analog, 2002;94:184–7.
• Ilett KF, Paech MJ, Page-Sharp M, Sy SK, Kristensen JH, Goy R, Chua S, Christmas T, Scott KL, Colostrum morphine concentrations during postcesarean intravenous patient-controlled analgesia, Anesth Analg, 2002;94:184–7.
• Oberlander TF, Robeson P, Ward V, Huckin RS, Kamani A, Harpur A, McDonald W, Prenatal and breastmilk morphine exposure following maternal intrathecal morphine treatment, J Hum Lact, 2000;16:137–42.
• Robieux I, Koren G, Vandenbergh H, Schneiderman J, Morphine excretion in breastmilk and resultant exposure of a nursing infant, J Toxicol Clin Toxicol, 1990;28:365–70.
• Naproxen  
• Naproxen is more than 99% bound to plasma proteins. Davies and Anderson (1997) reported that although naproxen is excreted into breastmilk, the amount of drug transferred comprises only a small fraction of the maternal exposure. In Jamali and Stevens’ study (1983) only 0.26% of the mother’s dose was recovered from the infant and adverse effect reports are low. However, this drug has a longer half-life than other NSAIDs, normally being taken only twice a day. The BNF considers that the amount of naproxen distributed into breastmilk is too small to be harmful to a breastfed infant; however, some manufacturers recommend that breastfeeding should be avoided during naproxen therapy, due to licencing considerations rather than potential risk. Relative infant dose is quoted as 3.3% (Hale 2017 online access). The BNF states that the amount in breastmilk is too small to be harmful but that the manufacturer advises use should be avoided.
• Compatible with use during breastfeeding due to limited transfer into breastmilk.
• References
• Davies NM, Anderson KE, Clinical pharmacokinetics of naproxen, Clin Pharmacokinet, 1997;32:268–93.
• Jamali F, Stevens DRS, Naproxen excretion in milk and its uptake by the infant, Drug Intell Clin Pharm, 1983;17:910–11.
• Diclofenac  
• Research studies are not widely documented as it is used less frequently in the USA than in the UK. However, the lack of reports of adverse effects suggests that there is little cause for concern. It has been one of the most widely used drugs in the immediate postpartum period in the UK but is now being replaced by naproxen because of the risk of cardio-vascular effects.
• Oral diclofenac is almost completely absorbed but it is subject to first-pass metabolism so less reached the systemic circulation. Its high plasma protein binding (in excess of 99%) limits its passage into breastmilk. It is widely used on post-natal wards. Relative infant dose is quoted as 1% (Hale 2017 online access). The BNF states that the amount present in breastmilk is too small to be harmful.

Compatible with use during breastfeeding due to limited transfer into breastmilk.

Omeprazole  

Omeprazole is rapidly destroyed in acid conditions of the stomach below pH 4. It is also given to infants to treat severe gastric reflux. It is 95% bound to plasma proteins. It is not licenced for use in children below 1 year but is used outside of its licence application at a dose of 700 µg per kilogramme per day for reflux compared with an estimated dose through breastmilk of 3 µg per kilogramme per day passing through breastmilk in the study of one mother (Marshall et al. 1998). Hale 2017 (online access) quotes the relative infant dose as 0.02%.

Omeprazole suspension (unlicenced) is the only proton pump inhibitor liquid preparation available for administration to infants. This preparation is a ‘special’ and needs to be ordered by the pharmacy from a specials laboratory. However, it is not licenced for children under 1 year of age. It is metabolised by the cytochrome P450 system so potential interactions are possible. The BNF reports that it is present in milk but that it is not known to be harmful.

Compatible with breastfeeding as destroyed at pH <4. Used directly in children with severe gastro oesophageal reflux disease.

References

• Marshall JK, Thompson AB, Armstrong D, Omeprazole for refractory gastroesophageal reflux disease during pregnancy and lactation, Can J Gastroenterol, 1998;12:225–7.
• National Institute for Health and Care Excellence (NICE), Gastro-oesophageal reflux disease: recognition, diagnosis and management in children and young people (cks.nice.org.uk/gord-in-children).

Some mothers develop fungal nail infections in pregnancy and delay treatment. When breastfeeding, topical treatments are preferable. I am asked at least once a week about oral terbinafine – hard to answer with little research. Hope this information helps with shared decision making.

Oral terbinafine and breastfeeding factsheet

Oral Terbinafine is sometimes used to treat fungal infection of the nails if topical products have failed to resolve symptoms. Treatment generally lasts for 3 months.

The most frequent adverse effects (for the mother) after oral use of terbinafine hydrochloride are gastrointestinal disturbances such as nausea, diarrhoea and mild abdominal pain. Loss or disturbance of taste may occur and occasionally may be severe enough to lead to anorexia and weight loss. Terbinafine hydrochloride is well absorbed from the gastrointestinal tract. The bioavailability is about 80% because of first-pass hepatic metabolism. Some people are unable to tolerate the drug because of side effects.

Oral terbinafine is extensively bound to plasma proteins (99%) so passage into breastmilk might be expected to be low. The only research refers to two women given a single dose of 500 mg; the total level of terbinafine measured in breastmilk during the 72-hour post-dosing period was 0.65 mg in one mother and 0.15 mg in another. Neither woman was breastfeeding, but both were producing some breastmilk (218 ml and 41 ml, respectively). After 18 hours, the levels of terbinafine were below the level of detection.

The volume of milk being produced by the mothers makes this study questionable as an evidence base. Similarly, the single dose does not replicate normal treatment. However, the authors suggested that using the average milk concentration values over the 24-hour period in the two subjects, an exclusively breastfed infant would receive 3.8% of the maternal weight-adjusted dosage of terbinafine.

Although unlicensed terbinafine has been used to treat tinea capitis in children (Gupta et al. 2003).

Skin concentrations may be up to 75-fold higher than those in the blood. It may persist in the skin for up to 8 weeks after the drug has been discontinued and in the nails for up to a year although treatment is stopped much sooner

The BNF reports that manufacturer advises avoidance of cream or tablets as it is present in milk but less than 5% of the dose is absorbed after topical application of terbinafine.

References

•             Leachman SA, Reed BR, The use of dermatologic drugs in pregnancy and lactation, Dermatol Clin, 2006;24:167–97.

•             Gupta AK, Adamiak A, Cooper EA, The efficacy and safety of terbinafine in children, J Eur Acad Dermatol Venereol, 2003;17:627–40.

•             Thieme G, Peuckert U, Report on a pharmacokinetic study of SF 86-327 in healthy females in the ablactation period. Sandoz document number 303-019. 1986 (information taken from report in Lactmed and Hale 2017 online access).

Further information

•             www1.racgp.org.au/ajgp/2019/october/superficial-fungal-infections

•             https://dermnetnz.org/topics/terbinafine/

See also

https://www.e-lactancia.org/breastfeeding/terbinafine/product/

https://www.ncbi.nlm.nih.gov/books/NBK501397/

Limited information indicates that oral maternal doses of 500 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Monitor the infant for jaundice or other signs of liver toxicity, especially in younger, exclusively breastfed infants

email wendy@breastfeeding-and-medication.co.uk

see also https://breastfeeding-and-medication.co.uk/fact-sheet/coughs-colds-flu-and-covid-when-breastfeeding

There is research that pseudoephedrine can lower breastmilk supply after just one tablet. (Aljazaf K, Hale TW, Ilett KF, et al. Pseudoephedrine: effects on milk production in women and estimation of infant exposure via breastmilk. Br J Clin Pharmacol. 2003;56(1):18-24.) Pseudoephedrine is a decongestant ( helps to unblock your nose). It seems that mothers in late-stage lactation may be more sensitive to pseudoephedrine and have greater loss in milk production. Therefore, breastfeeding mothers with poor or marginal milk production should be cautious in using pseudoephedrine. While there are anecdotal reports of its use in mothers with engorgement, we do not know if it is effective, or recommend its use for this purpose.

Many remedies contain phenylephrine as the decongestant. Because of pseudoephedrine’s effect on milk production, concerns that phenylephrine may suppress milk production may arise; there is no evidence that this occurs at this time. Decongestants decrease secretions so it is not an unreasonable assumption that it might reduce supply but that no one has conducted trials. This is a case of lack of evidence rather then evidence of lack of activity.

Decongestant nasal sprays act only locally so will not pass into milk or affect milk supply.

Decongestant nasal sprays and nose drops should only be used for about 5-7 days at a time. If they are used for longer than this a rebound, more severe congestion of the nose often develops. Decongestant sprays and drops are thought to work better than oral tablets or capsules (https://patient.info/chest-lungs/cough-leaflet/decongestants)

Nasal decongestants can offer symptomatic relief but not cure a common cold https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6461189/. Paracetamol, ibuprofen and steam inhalation are generally as effective and much cheaper.

In September 2023 the FDA reported that oral phenylephrine is not effective at relieving nasal stuffiness. It is important to note that neither FDA nor the Non-prescription Drug Advisory Committee raised concerns about safety issues with use of oral phenylephrine at the recommended dose. (https://www.fda.gov/…/fda-clarifies-results-recent…).

According to one USA website the evidence for efficacy was first questioned in 2007. The manufacturers have cited a survey that many people find its use beneficial as shown by sales volume of cough and cold products.

The vote that formally declared phenylephrine ineffective was in line with a review of pharmacology and clinical data presented by the FDA, which found the oral bioavailability of the drug is less than 1%, compared with 38%, a number often cited in the literature and based on outdated technology. (Medscape https://www.medscape.com/viewarticle/996369).

There appears to be no current UK recommendations although I am sure there is current discussion. Most oral cough and cold remedies currently contain phenylephrine as pseudoephedrine sales have been restricted. Between 2007 and 2008, the government introduced restrictions on their use because of concern that medicines containing these active substances could be used in the illicit manufacture of the Class A controlled drug methylamphetamine https://www.gov.uk/…/pseudoephedrine-and-ephedrine…

This information has been compiled from a variety of sources and does not imply recommendation other than that nasal decongestants and steam inhalation are effective in reducing symptoms of nasal congestion during breastfeeding without potential impact on supply. The choice of products is up to individuals.

Chest rubs such as Vick ™ may be overwhelming for a breastfeeding baby who is inhaling the smell. Anecdotally applying it sparingly to the feet under socks helps.