Is Prucalopride (a pro-kinetic laxative) 2 mg safe for use in a breastfeeding mother?

Prucalopride 2 mg Can Be Given to a Breastfeeding Mother with Appropriate Counseling

Prucalopride 2 mg is compatible with breastfeeding, as the infant receives only approximately 6% of the weight-adjusted maternal dose through breast milk, which is below the 10% threshold generally considered safe for breastfed infants. 1

FDA-Approved Safety Data

The FDA label provides direct evidence on prucalopride excretion in breast milk from a clinical study in lactating women 1:

• Prucalopride is present in breast milk with a milk-to-plasma ratio of 2.65:1 1
• The average amount transferred to the infant is estimated at 1.74 mcg/kg/day, representing only 6% of the maternal weight-adjusted dose 1
• This 6% relative infant dose is well below the 10% threshold that guidelines consider the preferred safety cutoff for medications during breastfeeding 2

Clinical Decision Framework

The decision to use prucalopride should weigh the mother's clinical need against theoretical infant risks, considering that there are no reported adverse effects in breastfed infants but limited long-term data 1:

• The study data comes from women in the weaning stage, so concentrations during full milk production may differ 1
• No data exist on actual effects on breastfed children or milk production 1
• The developmental and health benefits of breastfeeding should be considered alongside the mother's need for constipation treatment 1

Important Caveats and Monitoring

Monitor the infant for any signs of gastrointestinal effects, as prucalopride is a prokinetic agent 1, 3:

• Watch for changes in stool frequency, consistency, or feeding patterns
• The most common maternal adverse effects are headache, nausea, abdominal pain, and diarrhea, primarily on the first day of treatment 3
• These gastrointestinal effects are typically transient and mild-to-moderate 3, 4

Contraceptive Considerations

Women of childbearing age must use effective contraception while taking prucalopride, as it may reduce oral contraceptive efficacy and miscarriages have been reported in clinical trials 5:

• Prucalopride should not be taken during pregnancy 5
• Consider barrier methods or alternative contraception if using oral contraceptives 5

Alternative Approaches

Before initiating prucalopride, ensure adequate trial of lifestyle modifications and conventional laxatives, as this is a second-line agent 5, 3:

• Prucalopride is indicated specifically for chronic constipation when laxatives have failed to provide adequate relief 3, 6
• Focus on dietary fiber, hydration, and behavioral changes first 5
• Standard laxatives remain first-line therapy 5