Can domperidone be used to improve lactation in breastfeeding mothers?

Domperidone for Lactation Enhancement in Breastfeeding Mothers

Domperidone can effectively increase breast milk production in mothers with lactation insufficiency, particularly in mothers of preterm infants, though it is not FDA-approved for this indication in the United States and carries cardiac safety warnings that must be carefully considered.

Regulatory Status and Safety Concerns

• Domperidone is NOT FDA-approved for any use in the United States, and the FDA issued an import alert (2004, updated 2012) making its importation illegal except under investigational new drug applications 1
• The FDA issued a public safety warning specifically regarding domperidone use for lactation due to serious cardiac risks including QT prolongation, torsades de pointes, and sudden cardiac death 1
• Despite lack of FDA approval, domperidone is identified by the American College of Obstetricians and Gynecologists as a primary medication used to induce lactation, though it remains more commonly utilized than metoclopramide despite its regulatory status 2
• When used orally, domperidone levels in breast milk are low due to first-pass hepatic metabolism, making it compatible with breastfeeding from an infant exposure standpoint 3

Efficacy Evidence

Preterm Mothers (Strongest Evidence)

• In mothers of preterm infants, domperidone significantly increases breast milk production by approximately 88 mL/day compared to placebo (95% CI: 59.48-118.62 mL/day) and outperforms metoclopramide by 82.84 mL/day (95% CI: 37.04-118.95 mL/day) 4
• A 2021 randomized controlled trial demonstrated breast milk production increased from baseline 156 mL to 400.9 mL after 14 days of domperidone treatment (10 mg three times daily), compared to only 175.8 mL to 260.5 mL with placebo (p < 0.01) 5
• Domperidone treatment resulted in 95% exclusive breastfeeding rates at hospital discharge versus only 52.4% with placebo (p = 0.008) 5
• Prolactin levels increased significantly from 72.85 ng/mL to 223.4 ng/mL on day 7 with domperidone (p = 0.005), compared to no significant change with placebo 5

Term Mothers (Limited Benefit)

• In term mothers, domperidone did not demonstrate significant benefit over metoclopramide or placebo for increasing breast milk volume 4

Clinical Algorithm for Use

Step 1: Optimize Non-Pharmacologic Interventions First

• Ensure frequent feeding/pumping (at least 8-12 times per 24 hours) 2
• Verify proper latch technique 2
• Confirm adequate maternal hydration and nutrition 2
• Ensure access to breast pump if any delay in infant feeding occurs, as domperidone may increase supply before infant can effectively remove milk 2

Step 2: Exclude Medical Causes

• Rule out retained placental fragments 2
• Screen for thyroid dysfunction 2
• Assess for insufficient glandular tissue 2

Step 3: Consider Pharmacologic Intervention

• Notably, 71.7% of mothers with lactation failure were able to increase milk production without medication after proper counseling and breastfeeding management 5
• If pharmacologic intervention is needed after optimizing non-pharmacologic measures, metoclopramide should be considered first as it is FDA-approved and compatible with lactation 2
• Metoclopramide may increase milk supply and is explicitly compatible with use in lactating women according to the American Academy of Pediatrics 2, 3

Step 4: Domperidone Consideration (If Metoclopramide Fails or Is Contraindicated)

• Domperidone may be considered in mothers of preterm infants with documented lactation failure who have not responded to metoclopramide 4
• Screen for cardiac risk factors before prescribing: history of arrhythmias, QT prolongation, electrolyte abnormalities, concurrent QT-prolonging medications 1
• Typical dosing: 10 mg three times daily for 14 days 5
• Very small amounts of domperidone are detected in breast milk, minimizing infant exposure 6

Important Caveats

• The limited quality evidence for domperidone's effectiveness does not offset safety concerns from a public health perspective according to FDA analysis 1
• No serious adverse events were reported in the short-term studies analyzed, though sample sizes were small 5, 4
• Domperidone crosses the blood-brain barrier and into breast milk to a lesser extent than metoclopramide, potentially decreasing toxicity risk to both mother and infant 7
• An earlier study showed a more modest 44.5% increase in milk production with domperidone versus 16.6% with placebo over 7 days 6
• Research and drug development are needed to address the significant unmet medical need for lactation disorders with safer, FDA-approved alternatives 1