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Dr Morag Martindale and Patricia Wise advise how

to prescribe

safely for mothers who want to continue breast-feeding

If a breast-feeding mother is prescribed medication, an important consideration is whether enough of the drug is likely to be transferred to the baby via the breast milk to pose a problem to the baby. However, interrupting breast-feeding also introduces risks so should only be done if the risk from the medication is greater1.

There is an emotional and physiological fallout for mother and child. Most medications have few side-effects in breast-feeding infants because the dose transferred via milk is almost always too low to be clinically relevant.1

For most common conditions that GPs see there is a drug that is safe for a breast-feeding mother to take. If there is uncertainty about the safety of a particular drug in the baby there is usually an alternative that can be prescribed.

Being unlicensed for use during lactation does not mean a drug is unsafe to use, only that a licence has not been applied for, because insufficient research has been carried out on its safety. Drugs licensed for use in babies, such as fluconazole, are unlikely to present a risk.

Consequences of stopping

breast-feeding completely

If a mother is advised to stop breast-feeding, what are the health and development risks to consider for the baby? Changing to formula increases the risk of:


·otitis media3

·respiratory disease4

·urinary tract infections5

·asthma, if formula is introduced before four months of age6

·reduced scores on cognitive development at six-23 months7


·higher systolic blood pressure9.

The younger the baby the greater the risks. The mother is also affected, with an increased risk of:

·breast cancer10

·ovarian cancer11

·hip fracture when she is elderly12.

In addition, as breast-feeding is a special experience to many mothers, ending it unexpectedly early may well have a psychological impact in that the mother may grieve for the loss.

Stopping suddenly increases the chance of the mother developing mastitis so where stopping is unavoidable, she needs time to cut out feeds gradually and allow her body time to adjust the rate of milk production.

Coping with temporary cessation

of breast-feeding

If stopping temporarily is recommended, the mother may need information on how to manage the situation. If she chooses to express milk she will need to:

·consider what method of expressing to use (hand expressing, manual pump or electric pump)

·have time to learn to express effectively and to build up a sufficient supply of expressed breast milk (ebm)

·decide how the expressed milk is to be transferred to the baby ­ introducing a bottle to a baby who is not yet breast feeding well can interfere with establishing a good technique, which in turn may lead to early cessation of breast-feeding; alternatives to a bottle are a cup, spoon or syringe

·know that milk production will continue during the period of temporary cessation so she will need to express milk several times during a 24-hour period, both for comfort and to help maintain her supply

·have access to skilled support.

As breast milk is a precious commodity, discarding expressed milk may be emotionally upsetting for her.

Giving formula to a baby who has been exclusively breast-fed from birth introduces foreign proteins, raising the possibility of an allergic response6.

Weighing up the risks

Section 4 of the Scottish SIGN guidelines on postnatal depression13 lists general principles of prescribing during lactation:

·establish a clear indication for drug treatment (ie the presence of significant illness in the absence of acceptable or effective alternatives)

·use treatments in the lowest effective dose for the shortest period necessary

·drugs with a better evidence base (generally more established drugs) are preferable

·assess the benefit/risk ratio of the illness and treatment for both mother and baby/fetus.

The age of the baby is an important variable to consider. A term baby can cope with higher drug exposure than a premature baby and a traces of medication received through his mother's milk.

Continuing breast-feeding

The Scottish SIGN guidelines13 also give

guidance on managing the situation where it is necessary for a breast-feeding mother to take medication:

·Medications prescribed to breast-feeding mothers are best taken as a single dose and should be administered before the baby's longest sleep period

·Breast-feeding is best done immediately before administering the dose and should be avoided for one to two hours after any dose of medication (the time of highest plasma concentrations).

If the drug needs to be used with caution, the baby will need monitoring for any unusual signs or symptoms. The UK Drugs in Lactation Advisory Service gives further details.

Useful sources of information

Recommendations about the use of medications by breast-feeding mothers tend to err on the side of caution with regard to exposure of the baby to the drug. Information about the licensing of drugs pays little attention to the potential damage to breast-feeding, and therefore a baby's future health, as the possibility of litigation is likely to be of greater concern to manufacturers.

Thomas Hale has gathered together known information on around 3,000 drugs in his book on lactational pharmacology, Medications and Mothers' Milk, which is therefore a valuable resource.

The information includes a lactation risk category for each entry to assist in assessing the risk in each individual patient. Additional useful sources of further information are listed below.

Why bother?

Encouraging, supporting and protecting breast-feeding is crucial if mothers are to maintain breast-feeding ­ the physiological norm, providing the best nutrition and immunological protection for babies.

Given the pressures we are all under, even a brief acknowledgement of how much a breast-feeding mother is achieving can help her feel proud and perhaps encourage her to continue for longer. Providing helpline numbers and local contact details enables her to access skilled help. However, babies and mothers are not the only beneficiaries of good support as healthier children save the NHS time and money14.

Which drugs can be

used and when

Drugs deemed to be safe during lactation


















Asthma drugs







·ACE inhibitors



Upper GI












Drugs to be

used with caution





·tetracyclines (up to a week)




(no clinical indication for mother to stop breast-feeding provided baby is healthy and his/her progress is monitored; paroxetine may be the preferred SSRI because of its low milk/plasma ratio but fluoxetine or sertraline can be used)









(discard milk for eight hours after dose)

Asthma drugs

·there is no data available on beclometasone and budesonide

Drugs to avoid


·cox 2 inhibitors






Psychotropic drugs



Upper GI


Take-home points

·Stopping breast-feeding introduces risks

·A lactating mother needing medication can usually be prescribed a drug safe for breast-feeding; data sheets are often over-cautious

·Medications and Mother's Milk by

Hale is a useful source of


Risks to consider

Risks of giving drug

·Risks to the baby of receiving the drug via breast milk

·Plus, if breast-feeding is stopped:

·health risks to baby

·development risks to baby

·health risks to mother ·psychological impact on mother

·Drug interactions, where applicable

Risk of not giving drug

·Effect of condition/illness on mother

·Effect of condition/illness on baby

Sources of help

Skilled help with breast-feeding is available from:

·NCT Breast-feeding Line 8am-10pm 0870 444 8708

·Breast-feeding Network SupporterLine, 9.30am-9.30pm 0870 900 8787

·Association of Breast-feeding Mothers 020 7813 1481

·La Leche League 0845 120 29188

Useful websites

· ­ section on information on health benefits for mothers

·The UK Drugs in Lactation Advisory Service

· ­ Breast-feeding and Maternal Medication

· ­ a service of the American National Library of Medicine

· 0870 112 1120 ­ can order posters and other information for new mothers


1 T. Hale. Medications and Mothers' Milk. Pharmasoft Publishing

2 Howie PW et al (1990). Protective effect of breast-feeding against infection. BMJ 300: 11-16

3 Duncan B et al. (1993). Exclusive breast-feeding for at least four months protects against otitis media. Pediatrics 5: 867- 872

4 Galton Bachrach VR et al (2003). Meta-analysis of breast-feeding and the risk of hospitalisation for respiratory disease in infancy.

Arch. Pediatr Adolesc Med 157:237-243

5 Pisacane A et al (1992). Breast-feeding and urinary tract infection.

J Pediatr 120: 87-89

6 Oddy WH et al (2002). Maternal asthma, infant feeding, and the risk of asthma in childhood. J Allergy Clin Immunol Jul;110(1):65-67

7 Anderson JW et al. (1999) Breast-feeding and cognitive development:

a meta-analysis. Am J Clin Nutr 70:525-35

8 Armstrong J et al (2002). Breast-feeding and lowering the risk of childhood obesity. Lancet 359:2003-4

9 Martin RM et al (2004). Does Breast-feeding in infancy lower blood pressure in childhood? The Avon Longitudinal Study of Parents and Children (ALSPAC). Circulation 109:1259-66

10 Collaborative Group on Hormonal Factors in Breast Cancer (2002). Breast cancer and breast-feeding: collaborative reanalysis of individual data from 47 epidemiological studies in 30 countries, including 50,302 women with breast cancer and 96973 women without the disease.

Lancet 360(9328):187-95

11 Rosenblatt KA et al (1993). Lactation and the risk of epithelial ovarian cancer ­ The WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Int J Epidemiol 22: 499-503

12 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

13 SIGN (2002)

14 McConnachie A et al (2004). Modelling consultation rates in infancy: influence of maternal and infant characteristics, feeding type and consultation history. Br J Gen Pract 54: 598-603

Morag Martindale is a GP in Blairgowrie, Perthshire, and

Patricia Wise is breast-feeding tutor for the National Childbirth Trust

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