Is Xifaxan (Rifaximin) safe to use during breast-feeding?

Safety of Xifaxan (Rifaximin) During Breastfeeding

Rifaximin is not recommended for use during breastfeeding due to lack of safety data and potential risks to the breastfed infant.

Evaluation of Available Evidence

The FDA drug label for Xifaxan (rifaximin) clearly states that there is no information regarding the presence of rifaximin in human milk, its effects on breastfed infants, or its effects on milk production 1. This lack of specific safety data represents a significant concern when considering its use in breastfeeding mothers.

Pharmacological Considerations

Rifaximin has several characteristics that warrant caution:

• It is a non-systemic antibiotic with minimal absorption from the gastrointestinal tract
• There is no established safety profile for use during lactation
• The FDA label recommends considering "the development and health benefits of breastfeeding along with the mother's clinical need for XIFAXAN and any potential adverse effects on the breastfed infant" 1

Guidelines for Antibiotics During Breastfeeding

Current clinical guidelines provide recommendations for antibiotic use during breastfeeding, but rifaximin is notably absent from lists of preferred antibiotics:

• The North American clinical practice guidelines for special patient populations suggest several antibiotics that can be used during breastfeeding, including rifampin, amoxicillin/clavulanic acid, erythromycin, azithromycin, and metronidazole 2
• Short courses of antibiotics are generally considered safe for breastfeeding women, but this applies to well-studied antibiotics with established safety profiles 2

Decision-Making Algorithm for Rifaximin Use During Breastfeeding

1. Assess necessity: Determine if rifaximin is absolutely necessary or if alternative antibiotics with established safety profiles could be used
2. Consider alternatives: Use antibiotics specifically recommended for breastfeeding mothers:
   • Rifampin (if similar antimicrobial spectrum needed)
   • Amoxicillin/clavulanic acid
   • Erythromycin
   • Azithromycin
   • Metronidazole
3. If no alternatives are suitable:
   • Discuss temporary interruption of breastfeeding
   • Consider expressing and discarding milk during treatment
   • Resume breastfeeding after completion of therapy

Key Considerations and Precautions

• The benefits of breastfeeding are well-established, including nutritional value and protection against infection and immunologic disorders 3
• Only a few drugs pose a clinically significant risk to breastfed babies, but those without safety data should be approached with caution 4
• When prescribing for breastfeeding mothers, consider medications that are poorly absorbed orally to limit infant exposure 5

Conclusion

Given the lack of safety data for rifaximin during breastfeeding and the availability of alternative antibiotics with established safety profiles, rifaximin should not be the first choice for breastfeeding mothers. If treatment is necessary, consider using antibiotics specifically recommended in guidelines for breastfeeding women, such as rifampin, amoxicillin/clavulanic acid, erythromycin, azithromycin, or metronidazole 2.