Domperidone and breastfeeding - review

Domperidone and breastfeeding | Increase milk supply

Several factors can impact breast milk supply with common factors including insufficient frequency of breastfeeding, wrong latching by a baby, late start of breastfeeding, use of formula alongside breastfeeding and some drugs. Drug therapy to increase milk production is usually considered when insufficient milk is produced despite appropriate lactation support (Grzeskowiak et al, 2018). Today we look at the topic of domperidone and breastfeeding. One of the uncommon side effects of domperidone is galactorrhoea (excessive milk production), which leads to unlicensed use of this domperidone in breastfeeding to increase milk supply when breastfeeding.

What is domperidone?

Domperidone is a prescription-only medication (POM) licensed in the UK for the symptoms of nausea and vomiting. Domperidone is also known as Motilium, which is a branded name of domperidone. Both, the generic version and Motilium contain the same amount of the active drug – 10mg of domperidone per tablet.

Can you get domperidone over the counter?

No. Domperidone is a prescription-only medication and requires a qualified prescriber, for example, a doctor to issue a prescription for the drug. In the past domperidone used to be available from the pharmacy as over the counter medication, sold as Motilium 10 and Motilium instants. In 2014, domperidone was reclassified as a pharmacy-only medication, consequently, all pharmacy-only products were recalled.

Domperidone and breastfeeding - can you use it to increase milk supply?

The reclassification of domperidone happened because the use of this drug was associated with a small increased risk of serious cardiac side effects (eg, QTc prolongation, torsade de pointes, serious ventricular arrhythmia, and sudden cardiac death).

Domperidone and breastfeeding: how does domperidone increase milk supply?

Domperidone is one of the most commonly used drugs when an increase in breast milk supply is needed. As stated in the introductory paragraph, one of the uncommon side effects of domperidone use is increased milk production (galactorrhoea) alongside other uncommon side effects such as breast pain and breast tenderness. Uncommon side effect happens infrequently with estimated patients between >= 1/1000 and < 1/100.

Domperidone is classified as a dopamine receptor antagonist, which in plain language means that it stops dopamine (a type of neurotransmitter) from working. Dopamine, which is released in one part of the brain stops the release of a hormone called prolactin, which promotes lactation (milk production). Since domperidone stops dopamine from working, more prolactin is secreted in the brain and this promotes milk production.
During pregnancy, prolactin levels increase breast to grow (increasing the size of the mammary glands) and stimulate milk production.

Domperidone & breastfeeding: can domperidone increase milk production?

Several studies investigated the use of domperidone in breastfeeding. The best available evidence comes from a systemic review of those studies.
Grzeskowiak et al reviewed 5 clinical trials on the effect of domperidone on milk production in breastfeeding women who expressed their milk for their preterm infants (<37 weeks gestation). In total 194 mothers took part in clinical trials (Grzeskowiak et al, 2018).

The main finding from this review:

  • One average mother who took domperidone increased daily breast milk volume by 88.3ml
  • Short-term use of domperidone increased the amount of milk produced in mothers of preterm infants
  • Domperidone was well tolerated by the mother with no side effect reported (no report of prolonged QTc syndrome
  • Adverse side effects experienced by neonates were reported in 3 out of 5 studies with two studies with only one study confirming adverse events (DOUBLE CHECK). In one study 91 infants were investigated for possible QTc syndrome at the start of the study and 76 infants at the end of the study. Only 5 infants were found to have QTc interval >500ms, however, no medical intervention or treatment was required.

Cochrane produced recently a newer review to investigate the effect of milk boosters (drugs, herbal products or foods) on milk production in breastfeeding mothers of healthy infants born at term (Foong et al, 2020).

Cochrane covered 41 studies with a total of 3005 mothers and 3006 infants. Nine studies compare the use of pharmacological drugs to increase milk supply. Domperidone was one of the drugs investigated alongside other galactagogues (drugs or foods that increase production of the milk) including metoclopramide, sulpiride, and thyrotropin-releasing hormone.

Some findings from this large meta-analysis (review of different studies / clinical trials):

    • Overall, the evidence behind all studies was graded as low or very low
    • Three studies compared metoclopramide, domperidone and sulpiride on the volume of milk produced

Based on the above studies it was concluded that pharmacological (drug) milk boosters such as domperidone, may increase milk volume (average in milk production was 63ml, ranging from 26ml to 102ml), however, the evidence was marked as low quality with only 152 participants taking part in this study

Cochrane concluded that due to the low quality of evidence, it is unknown if galactagogues have any
effect on mothers who breastfed at 3,4 and 6 months.

Domperidone & breastfeeding: dose

The use of domperidone to increase milk production is an unlicensed use for this medication, which means no dose will be provided in the product information leaflet. Patients should get the directions for the dose of domperidone in breastfeeding from their GP. However, the standard dose for an adult using domperidone is One 10mg tablet up to three times per day with a maximum dose of 30 mg per day.

Can you get domperidone prescribed on NHS?

National guideline on breastfeeding recommends several measures regarding breastfeeding problems. In the first instance, a woman with breastfeeding problems needs to be offered appropriate training by a health visitor or breastfeeding specialist and written information on infant positioning and attachment in breastfeeding together with a number of other recommendations.
Additionally, breastfeeding mothers may be offered details of local and national breastfeeding support groups, for example, The Association of Breastfeeding Mothers or The Breastfeeding Network.
Breastfeeding mothers may be examined to exclude other underlying problems, such as blocked duct, galactocele (presence of a milk cyst) or ductal infection (bacterial or fungal).
Domperidone can be considered as an off-licensed treatment to help improve milk supply possibly after a referral to an endocrinologist is made (NICE, 2023).

It can be concluded that an NHS doctor can prescribe domperidone in breastfeeding, however, it is not a first-line recommendation.

Domperidone & breastfeeding: possible side effects

The most common side effect associated with domperidone use is dry mouth. Some possible, uncommon side effects can be experienced when domperidone is taken including:
• Anxiety
• Agitation
• Nervousness
• Loss of interest in sex
• Headache
• Sleepiness / feeling dizzy
• Diarrhoea
• Rash/hives/itchiness
• Painful breast
• Milk discharge from breasts
• Feeling weak
Although dizziness and sleepiness are uncommon side effects, patients are advised not to drive or operate machinery should they experience confusion, sleepiness, or lack of control.
Is domperidone excreted in breast milk?
Domperidone is excreted in human milk, with an estimated amount of less than 0.1% of the given dose. The risk of possible side effects cannot be excluded in infants who are breastfed.

Domperidone and breastfeeding: what is the dose?

The use of domperidone in breastfeeding to increase milk production is an unlicensed indication. When used to prevent nausea and vomiting, the recommended daily dose is one tablet taken three times a day (10mg three times a day) with a maximum of three tablets in one day (maximum 30mg daily).
This is a standard dose for domperidone. Mothers who took part in clinical trials discussed in this post in most cases were given 1 tablet three times a day.
• Domperidone tablets should not be taken for longer than 7 days in a row without consulting a doctor.
• Domperidone should be taken before food (15-30 mins before a meal).
How much does domperidone cost?
Generic domperidone 10mg tablets (price, August 2023):
– pack of 30 tablets for £0.50
Motilium (branded domperidone 10mg tablets):
– pack of 30 tablets: £0.57

Prices would only be relevant to patients apply to patients who were prescribed domperidone on a private prescription. The above prices are trade prices. When a supply of a drug is made on a private prescription, customers are expected to pay an additional fee (an additional 10%-20%) or a minimum charge, which varies between pharmacies. Patients should expect to pay around £7-£10 for dispensing domperidone on a private prescription.

Conclusion

Domperidone is one of the first choices when drug therapy is considered due to its relative safety to both mothers and newborn babies (Haase 2016; Winterfeld 2012). Perhaps as Cochrane Collaboration concluded, ‘an urgent’ randomised control trial is needed to assess the effectiveness of domperidone and other drugs in breastfeeding and its impact on milk production.

References
Grzeskowiak LE, Smithers LG, Amir LH, Grivell RM. Domperidone for increasing breast milk volume in mothers expressing breast milk for their preterm infants: a systematic review and meta-analysis. BJOG. 2018 Oct;125(11):1371-1378. doi: 10.1111/1471-0528.15177. Epub 2018 Mar 27. PMID: 29469929. Available at: https://doi.org/10.1111/1471-0528.15177 Accessed on 18/08/2023
Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database of Systematic Reviews 2020, Issue 5. Art. No.: CD011505. DOI: 10.1002/14651858.CD011505.pub2. Available at: https://doi.org/10.1002/14651858.CD011505.pub2 Accessed on 18/08/2023
Haase B, Taylor SN, Mauldin J, Johnson TS, Wagner CL. Domperidone for Treatment of Low Milk Supply in Breast Pump-Dependent Mothers of Hospitalized Premature Infants: A Clinical Protocol. J Hum Lact. 2016 May;32(2):373-81. doi: 10.1177/0890334416630539. Epub 2016 Feb 23. PMID: 26905341. Available at: https://doi.org/10.1177/0890334416630539
NICE (2017). Breastfeeding problems. Available at: https://cks.nice.org.uk/topics/breastfeeding-problems/ Accessed on 14/08/2023
Winterfeld U, Meyer Y, Panchaud A, Einarson A. Management of deficient lactation in Switzerland and Canada: a survey of midwives’ current practices. Breastfeed Med. 2012 Aug;7:317-8. doi: 10.1089/bfm.2011.0092. Epub 2012 Jan 6. PMID: 22224508. https://doi.org/10.1089/bfm.2011.0092

I am a qualified pharmacist working in an independent pharmacy in the UK.
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