Is diosmin + hesperidin (flavonoid combination) safe for a breastfeeding woman?

Is Diosmin + Hesperidin Safe for Breastfeeding?

Diosmin + hesperidin is NOT recommended during breastfeeding due to insufficient safety data and explicit manufacturer warnings against use in lactating women.

FDA-Approved Drug Label Guidance

The FDA-approved labeling for VASCULERA (diosmiplex, containing diosmin) explicitly states: "Effects in infants of nursing mothers are uncertain for chronic dosing. Therefore, VASCULERA (diosmiplex) is not recommended in pregnant and lactating women." 1

This represents the highest level of prescribing guidance available and should be followed in clinical practice 1.

Limited Clinical Evidence

While some limited data exist for short-term use:

• A small study showed that 50 pregnant women took micronized diosmin 90% and hesperidin 10% for hemorrhoids, continuing for a median of 4 weeks postpartum, with no reported effects on "infant growth and feeding" 2
• However, this study did not specifically assess drug transfer into breast milk, infant serum levels, or long-term safety outcomes 2

The critical limitation is that no studies have measured diosmin or hesperidin concentrations in breast milk or assessed infant exposure levels during chronic maternal dosing 1.

Pharmacological Considerations

• Diosmin is converted to diosmetin after oral administration, which is then glucuronidated and excreted in urine 3
• Diosmin demonstrates inhibitory effects on various metabolic enzymes, raising concerns about potential drug interactions and unknown effects in nursing infants 3
• The molecular characteristics and transfer potential into breast milk remain poorly characterized 1

Clinical Recommendation Algorithm

When a breastfeeding woman requires treatment for venous insufficiency or hemorrhoids:

1. First-line approach: Use medications with established safety profiles during lactation, such as topical treatments or other agents with documented compatibility 4, 5

2. If flavonoid therapy is deemed essential:

   • Discuss the lack of safety data with the patient 1
   • Consider temporary cessation of breastfeeding if treatment cannot be deferred 4
   • Evaluate whether the condition can wait until after lactation is complete 6

3. Do not prescribe diosmin + hesperidin as a routine option for breastfeeding women given the manufacturer's explicit recommendation against use 1

Key Pitfalls to Avoid

• Do not assume safety based on "natural" or herbal origin - many plant-derived compounds transfer into breast milk and affect infants 6
• Do not rely solely on the pregnancy data - the postpartum study only followed infants for 4 weeks and did not measure drug levels in milk 2
• Do not dismiss manufacturer warnings - the FDA label explicitly advises against use in lactation due to uncertain infant effects 1