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#239 Need milk? Domperidone for increasing breast milk supply


CLINICAL QUESTION
What is the efficacy and safety of domperidone to increase milk supply in breastfeeding mothers?

BOTTOM LINE
In mothers of pre-term infants, domperidone increases milk volume by ~90 ml more than placebo after 14 days, with an additional 1 in 5 women experiencing a 50% increase in milk supply. Doses above 30 mg/day are likely not needed and may increase the risk of arrhythmias. Optimal length of treatment unknown. 


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EVIDENCE
  • Efficacy: 
    • Newest systematic review of 5 placebo-controlled trials of 192 breastfeeding mothers of pre-term infants. All used 10mg PO TID for 5-14 days:1 
      • Mean increase in expressed breast milk volume: 88 ml/day over placebo. 
      • Maternal adverse effects: no difference. 
      • Infant adverse effects: either no difference or not reported. 
    • Largest RCT from above systematic review (90 mother-baby pairs):2 
      • Women with 50% increase in milk supply at 14 days: 78% domperidone versus 58%, Number Needed to Treat (NNT)=5.
      • Mean daily milk volume: 267 ml domperidone versus 168 ml (not statistically different, but likely underpowered). 
      • No difference in breastfeeding rates at 6 weeks. 
  • Cardiac harms: 
    • Canadian observational study of 45,518 women given domperidone in the 6 months postpartum:3 
      • Risk of hospitalizations for ventricular arrhythmia: 1.3/10,000 (domperidone) versus 0.55/10,000 (no domperidone): no statistical difference. 
        • If real, would equal a number needed to harm of 12,950. 
      •  Systematic review of 6 case control studies, mainly in men over age 60:4 
        • Arrythmia risk highest in doses >30 mg/day (OR=3.32) versus ≤30 mg/day (OR=1.63).
Context: 
  • Small RCTs (7-15 women) found no difference in efficacy between 30mg/day and 60mg/day.5,6 
  • Low amounts of domperidone enter breastmilk (example <7mcg/day based on 80mg daily dose),7 but infant adverse effects similar to placebo.2,7 
  • In 2015, Health Canada warned of domperidone use and abnormal heart rhythms/sudden cardiac death. While available evidence may not apply to breastfeeding population, domperidone is contraindicated if risk of arrhythmias (examples cardiac disease/conduction abnormalities, concurrent QTc prolonging drugs or potent CYP3A4 inhibitors).8 
  • There is insufficient evidence on the use of herbal galactagogues (example fenugreek).9 
July 8, 2019

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Author(s):

  • Adrienne J Lindblad BSP ACPR PharmD
  • Christina Korownyk MD CCFP

1. Grzeskowiak LE, Smither LG, Amir LH, et al. BJOG. 2018; 125:1371-8.

2. Asztalos EV, Campbell-Yeo M, da Silva OP, et al. J Hum Lact. 2017; 33(1):181-7.

3. Smolina K, Mintzes B, Hanley GE, et al. Pharmacoepidemiol Drug Saf. 2016; 25(10):1210-14.

4. Leelakanok N, Holcombe A, Schweizer ML. Clin Drug Investig. 2016; 36(2):97-107.

5. Knoppert DC, Page A, Warren J, et al. J Hum Lact. 2013; 29(1):38-44.

6. Wan EW, Davey K, Page-Sharp M, et al. Br J Clin Pharmacol. 2008; 66(2):283-9.

7. Paul C, Zenut M, Dorut A, et al. J Hum Lact. 2015; 31(1):57-63.

8. Health Canada. Available at: http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/43423a-eng.php Accessed 21-FEB-2019.

9. Bazzano AN, Hofer R, Thibeau S, et al. Ochsner J. 2016 Winter; 16(4):511–524.

Authors do not have any conflicts of interest to declare.