Dr. Kara Jansen (biography and disclosures)
What I did before
When I was in medical school and residency it was common to see domperidone prescribed for lactation support, usually because a new mum told us she “didn’t have enough milk”. It was given in high doses (20mg QID) often for months on end. There was little, if any, discussion about the rationale for its use, potential side-effects, or other measures to increase lactation.
What changed my practice
In 2009 I spent a year studying Breastfeeding Medicine in Melbourne, Australia. I now understood more about the physiology of lactation and the role we think domperidone plays in supporting lactation. I knew how to support new mothers to maximize milk production without needing medication, but still often used domperidone as a galactagogue without a lot of thought to its potential side-effects. Then, in March 2012, Health Canada put out an advisory about the use of domperidone and its association with “serious ventricular arrhythmias and sudden cardiac death”.1 Suddenly, I had lots of colleagues and patients asking me questions about the safety and appropriate use of domperidone, and I started to question my own practice of prescribing it.
Domperidone is a peripheral dopamine antagonist which is thought to increase milk production by increasing prolactin levels.2 Its approved use is as an antiemetic agent for treatment of upper gastric motility disorders. Prolactin is particularly important in establishing lactation during lactogenesis II, but once established, prolactin is less important in the maintenance of lactation.3 For this reason it is thought that domperidone is particularly effective as a galactogogue if used within the first 4 weeks postpartum. 3 Common side-effects experienced by mothers include headache, dry mouth, GI upset, fatigue, and rash. Serious side-effects include arrhythmias or, rarely, seizures. Domperidone passes through to the milk in very small quantities, and is not known to cause any side-effects in babies. Unlike metoclopramide, it does not pass through the blood brain barrier.4
Adequate breastfeeding support is the most important step in establishing successful lactation. There are multiple factors which influence how well lactation is established: how soon after delivery the baby is put skin to skin and has his or her first latch; how effective the latch is; how frequently the baby is put to the breast; maternal and infant pre-existing conditions that can affect milk production; medications the mother may be taking; anatomical features like a tight lingual frenulum in baby. There are lots of ways in which breastfeeding can, and should, be supported without using galactogogues. These medications should be reserved for cases where despite maximizing latch/milk transfer/frequent drainage (with baby and/or pump) there is not enough milk produced for the baby’s needs. All of these mothers need close follow up and help with breastfeeding.
There is a paucity of literature on the use of domperidone in lactation, and most studies focus on preterm babies whose mothers are exclusively pumping for ease of tracking volumes.5, 6, 7, 8, 9, 10 From that data we are able to make some generalizations which seem reasonable. The most studied dose is 10mg TID for 14 days.7 There are some studies in progress looking at a dose of 20mg TID for up to 28 days, but that is the upper limit, although in practice it is used in higher doses.5,11 Pumped milk volumes are reported to increase up to 44% after a week on domperidone.6
In terms of the Health Canada warning, it was based on two studies which did not involve lactating mothers or babies (average age 72.5 and 79.4).12,13 Most breastfeeding experts agree that in a healthy mother without a history of cardiac disease, and in the absence of other medications which could interact with domperidone to prolong the QT interval, domperidone is safe to use for a short term, at the lowest effective dose, when all other lactation support has been exhausted.11 A screening EKG is not generally recommended in healthy mothers without any known risk factors.11
What I do now
In my work at the Vancouver Breastfeeding Center, I like to see babies and mothers who are struggling with supply as early as possible. By optimizing latch and milk transfer, most mothers do not need domperidone to support lactation. I have a discussion with mothers who are feeding and pumping regularly and still do not have enough supply, about the appropriate use of domperidone, and the potential side-effects. If they are interested in trying it, I start with 10mg TID x 1-2 weeks and then assess their response based on the increase in their pumped milk volumes. All mothers who are given domperidone should be pumping as well, to maximize and assess its benefit. It would be unusual to have to use the medication for longer than a month, or at a higher dose, although each case must be looked at individually. In rare cases where mothers are not able to taper off after a month (with decreased milk documented with taper), a maximum dose (expert opinion) would be 20mg QID with frequent monitoring and trials of decreasing.11 While there is no official upper limit for time postpartum before starting domperidone, we know that it will work best if started in the first 4-6 weeks, and the available studies have not looked at starting it beyond the first month.
- Health Canada Endorsed Important Safety Information on domperidone maleate, March 2, 2012. (View article)
- Osadchy, A., Moretti, M.E., Koren, G. Effect of domperidone on insufficient lactation in puerperal women: a systematic review and meta-analysis of randomized controlled trials. Obstetrics and Gynecology International. 2012. 2012: 642893. (View article)
- Riordan, J. and Wambach, K. (2010). Breastfeeding and Human Lactation. Mississauga, Ontario: Jones and Bartlett Publishers. (View book with UBC)
- Hale, T.W. Medications and Mother’s Milk: A Manual of Lactational Pharmacology, 12th Ed. Hale Publishing, LP. Amarillo, Texas. 2006. (View book with UBC)
- Asztalos, E.V., Campbell-Yeo, M., daSilva, O.P., Kiss, A., Knoppert, D.C., Ito, S. Enhancing breast milk production with domperidone in mothers of preterm neonates (Empower trial). BMC Pregnancy and Childbirth. 2012; 12(87). (View article)
- daSilva, O.P., Knoppert, D.C., Angelini, M.M., Forret, P.A. Effect of domperidone on milk production in mothers of premature newborns: a randomized, double-blind, placebo-controlled trial. CMAJ. 2001; 164(1):17-21. (View article)
- Donovan, TJ, Buchanan, K. (2012). Cochrane Review: Medications for increasing milk supply in mothers expressing breastmilk for their preterm hospitalised infants. The Cochrane Library. 2012(3). (View with UBC or CPSBC)
- Forinash, A.B., Yancey, A.M., Barnes, K.N., Myles, T.D. The use of galactogogues in the breastfeeding mother. The Anals of Pharmacotherapy. 2012; 46(10):1392-1404. (View with UBC or request from CPSBC)
- Ingram, J., Taylor, H., Churchill, C., Pike, A., and Greenwood, R. Metoclopramide or domperidone for increasing maternal breast milk output: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2012; 97(4):F241-F245. (View article with UBC or request from CPSBC)
- Knoppert, D.C., Page, A., Warren, J., Seabrook, J.A., Carr, M., Angelini, M., Killick, D., and da Silva, O.P. The effect of two different domperidone doses on maternal milk production. J Hum Lact. 2013; 29(1):38-44. (View article with UBC or request from CPSBC)
- Flanders, D. et al. (2012). A Consensus Statement on the use of domperidone to support lactation. (View article)
- van Noord, C., Dieleman, J.P., van Herpen, G., Verhamme, K, and Sturkenboom, M.C.J.M. Domperidone and ventricular arrhythmia or sudden cardiac death: a population-based case-control study in the Netherlands. Drug Safety. 2010; 33(11):1003-1014. (View article with UBC or request from CPSBC)
- Johannes, C.B., Varas-Lorenzo, C., McQuay, L.J., Midkiff, K.D., and Fife, D. Risk of serious ventricular arrhythmia and sudden cardiac death in a cohort of users of domperidone: a nested case-control study. Pharmacoepidem and Drug Safety. 2010; 19(9):881-888. (View article with UBC or request from CPSBC)
- Bunik, M., Chantry, C.J., Howard, C.R., Lawrence, R.A., Marinelli, K.A., and Noble, L. ABM Clinical Protocol #9: Use of galactogogues in initiating or augmenting the rate of maternal milk secretion. 2011; 6(1):41-48. (View article)
- Bozzo, P., Koren, G., Ito, S. Health Canada advisory on domperidone: Should I avoid prescribing domperidone to women to increase milk production? Canadian Family Physician. 2012; 58(10):952-953. (View article)
- Sachs, H.C. and Committee on Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013; 132(3):e796-e809. (View article with UBC or request from CPSBC)
- Zuppa, A.A., Sindico, P., Orchi, C., Carducci, C., Cardiello, V., Romagnoli, C., and Catenazzi, P. Safety and efficacy of galactogogues: substances that induce, maintain and increase breast milk production. J Pharm Pharmaceut Sci. 2010; 13(2):162-174. (View article)