by Dr Louise Santhanam, General Practitioner
PLEASE NOTE– This information is not intended as a ‘guideline’ for the prescribing clinician, but rather as a summary of the issues with signposting to information from the UK Medicines Information Service (UKMi) and other organisations. The decision and responsibility for prescribing a medication for use as a galactagogue is that of the prescriber.
In some areas of the UK local prescribing guidelines may exist and these should also be consulted.
Indications for Use of a Galactagogue
If low breastmilk milk supply is suspected it is essential that:
- Urgent Paediatric advice is sought if there are concerns about the infant’s health eg. dehydration or poor weight gain1
- A breastfeeding assessment is undertaken by a skilled lactation supporter2 in order to
- Encourage maternal confidence
- Assess a full feed
- Provide information on effective positioning, attachment and sucking behaviour
- Encourage frequent feeds, effective breast drainage and expressing breastmilk to stimulate milk production
- Encourage skin-to-skin contact to facilitate frequent feeding
- Causes of decreased maternal responsiveness to infant feeding cues are considered and addressed eg. depression and anxiety
Only in exceptional circumstances should a galactagogue be prescribed1-5
- Treatable causes, such as ineffective attachment and positioning have been optimised.
- Increased frequency of breastfeeding, hand expression of milk, and breast pumps have all been tried without effect.
- There is a faltering milk supply due to illness in the infant or mother or due to prematurity.
- There has been unavoidable separation of the infant and mother.
- After expression of milk by hand or by pump for weeks, there is a decline in milk production.
- Re-lactation (reestablishing milk supply after cessation of breastfeeding) is advisable.
- Establishing adoptive nursing.
Use of a galactagogue should be accompanied by ongoing regular effective milk drainage from the breast in order to maintain the milk supply2.
A health professional should always be involved in the decision to use a galactagogue.
There are no drugs currently licensed in the UK as galactagogues so prescribing for this purpose is off-label.
Domperidone and Cardiac Risk
In April 2014 the MHRA issued a warning about the use of Domperidone. The MHRA warning followed a review in 2014 by the European Medicines Agency (EMA). The EMA reviewed the safety and efficacy of domperidone and found that domperidone was associated with a small increased risk of serious cardiac adverse effects such as QTc prolongation, torsade de pointes, serious ventricular arrhythmias and sudden cardiac death. A higher risk was observed in:
- People older than 60 years
- Adults taking daily oral doses of more than 30 mg
- Those taking QT-prolonging drugs or CYP3A4 inhibitors concomitantly
Domperidone is therefore contraindicated in people4:
- With conditions where the cardiac conduction is, or could be, impaired (including electrolyte imbalance in mother or infant2)
- With underlying cardiac diseases such as congestive heart failure
- Receiving other medications- either known to prolong the QT interval, or potent CYP3A4 inhibitors
- With severe hepatic impairment
Regarding the MHRA warning, The UK Medicines Information Service (UKMi) states ‘Although the scope of this review does not cover use for unlicensed indications (off-label use) the principles behind these recommendations should be considered whenever Domperidone is used, including as a galactogogue to enhance lactation’4.
The applicability of the MHRA warning to the use of domperidone in lactating women has been challenged on the grounds that domperidone is an effective option for inadequate lactation when other management strategies have failed, it is used in a cohort of younger women, and there is no direct evidence for any cardiac-related adverse effects in lactating mothers3.
The following advice is given by the UK Drugs in Lactation Advisory Service (UKDILAS)5:
- A maternal daily dose of 30mg Domperidone should not be exceeded
- The maximum treatment duration should not usually exceed one week
- Domperidone should not be used for inadequate lactation where the mother or infant has a cardiac disorder or are receiving treatment with drugs known to affect the QT interval e.g. ketoconazole or erythromycin, in which case Metoclopramide is preferred
‘As long as the possible cardiac effects are taken into account, domperidone is considered to be the agent of choice for inadequate lactation because of its superior side effect profile, efficacy, and minimal passage into breast milk’5.
It would seem prudent to advise a woman taking domperidone to seek prompt medical attention if symptoms such as maternal syncope or palpitations arise during treatment, or associated changes in infant behaviour are observed2.
Summary on the Use of Domperidone
The UK Medicines Information Service/UKDILAS states: ‘As there are limited alternative options for the stimulation of lactation, the use of Domperidone can be considered provided there is evidence of thorough evaluation for treatable causes such as poor attachment, and when increased frequency of breastfeeding, pumping or hand expression of milk has not been successful. A maternal dose of 30mg daily for a maximum of 1 week should not be exceeded. The same contraindications recommened[ed] in the EMA review apply to its use as a galactogogue in both mother and infant’4.
Considerations regarding prescribing a galactagogue therefore should include ensuring a feeding assessment and relevant non-drug measures to increase milk supply have been attempted first, assessment of cardiac risk for mother and infant and a risk/benefit discussion with the woman. NICE CKS suggests seeking Endocrinology advice before prescribing domperidone as a galactagogue1, although it is likely that such advice may be difficult to obtain in the time-frame necessary to preserve a diminishing milk supply.
As the responsibility for unlicensed prescribing falls to the individual clinician, careful justification and documentation of the rationale behind a prescribing decision is advisable and ongoing lactation support will be necessary for the mother.
UK Drugs in Lactation Advisory Service (UKDILAS): Drug Treatment of Inadequate Lactation Updated March 2016 – Summarises the indications for use of galactagogues and includes a link to the UK Medicines Information (UKMi) Q&A Drug Treatment of Inadequate Lactation, which includes information on Domperidone, Metoclopramide, Sulpiride and Herbal Medications from October 2014.
The Breastfeeding Network: Increasing Milk Supply- Use of Galactagogues June 2014 – Includes advice on how to increase milk supply without the use of drugs.
The Breastfeeding Network: Domperidone and Breastfeeding July 2015 – Details the evidence surrounding the use of domperidone specifically as a galactagogue.
Statement by The National Infant Feeding Network: The use of Domperidone in Inadequate Lactation December 2014 – Includes information on the MHRA warning and its applicability to lactation, and links to the evidence base for the effectiveness of Domperidone.
NICE CKS: Breastfeeding Problems- Management Low Milk Supply Revised January 2017
Alternatives to Drug Treatment
Academy of Breastfeeding Medicine: ‘Audio Galactagogue’ Relaxation Download A 20-minute relaxation recording shown to increase milk production if used during pumping and cited in the Cochrane Review: Methods of Milk Expression for Lactating Women September 2016
The UK Drugs in Lactation Advisory Service states that there is currently insufficient data to support the use of herbal galactagogues5.
- NICE CKS: Breastfeeding Problems- Management Low Milk Supply Revised January 2017
- The Breastfeeding Network: Domperidone and Breastfeeding July 2015
- UK Medicines Information (UKMi) Q&A 73.5 Drug Treatment of Inadequate Lactation, October 2014
- UK Drugs in Lactation Advisory Service (UKDILAS): Evidence Summary Domperidone May 2014
- UK Drugs in Lactation Advisory Service (UKDILAS): Drug Treatment of Inadequate Lactation Updated March 2016