Is Levaquin (levofloxacin) safe during breastfeeding?

Levofloxacin (Levaquin) Safety During Breastfeeding

Levofloxacin (Levaquin) should not be used during breastfeeding due to potential risks to the infant, and alternative antibiotics should be selected when treatment is needed for a breastfeeding mother. 1

FDA Recommendations and Rationale

• The FDA label explicitly states that levofloxacin is excreted in human breast milk and recommends discontinuing either breastfeeding or the medication due to potential serious adverse reactions in nursing infants 1
• The FDA guidance emphasizes making a decision between discontinuing nursing or discontinuing the drug, taking into account the importance of the drug to the mother 1
• Fluoroquinolones like levofloxacin have been associated with risks including tendon problems, which raises concerns about potential effects on developing infants 1

Safety Concerns with Fluoroquinolones During Lactation

• Fluoroquinolones have been associated with cartilage damage in animal studies, raising theoretical concerns about effects on developing infants 2
• While human data suggest low risk for fluoroquinolones in general, they are typically not recommended as first-line treatment during lactation 2
• If fluoroquinolones are clinically indicated, ciprofloxacin is the preferred agent within this class due to more extensive safety data 2

Safer Antibiotic Alternatives During Breastfeeding

• Several antibiotic classes are considered compatible with breastfeeding and should be used preferentially 2:
  • Penicillins (e.g., amoxicillin) - considered compatible with breastfeeding 2
  • Cephalosporins (e.g., cefuroxime) - human data indicate they are not teratogenic and are compatible with breastfeeding 2
  • Macrolides (e.g., azithromycin) - considered probably safe, though there is a very low risk of hypertrophic pyloric stenosis if used during the first 13 days of breastfeeding 2

Important Considerations When Prescribing Antibiotics to Breastfeeding Mothers

• Most systemic antibiotics will be present in breast milk and could potentially cause falsely negative cultures in febrile infants or produce gastroenteritis due to alteration of intestinal flora 2
• The transfer of medications into breast milk depends on concentration gradients allowing passive diffusion of non-ionized, non-protein-bound drugs 3
• Medication exposure to the infant can be limited by prescribing antibiotics that are poorly absorbed orally or by timing breastfeeding to avoid peak maternal serum drug concentrations 3

Clinical Decision Algorithm for Antibiotic Selection in Breastfeeding Mothers

1. First-line options: Penicillins (amoxicillin), cephalosporins (cefuroxime) 2
2. Second-line options: Macrolides (azithromycin) if not within first 13 days of breastfeeding 2
3. Third-line options: If fluoroquinolones are absolutely necessary, ciprofloxacin is preferred over levofloxacin 2
4. Avoid: Levofloxacin and other fluoroquinolones unless benefits clearly outweigh risks 1, 4

Common Pitfalls to Avoid

• Do not assume that all antibiotics carry equal risk during breastfeeding; there is significant variation in safety profiles 5
• Do not continue breastfeeding without considering alternatives if levofloxacin is prescribed, as the FDA explicitly recommends choosing between the medication and breastfeeding 1
• Do not overlook the potential for antibiotics in breast milk to alter infant gut flora or interfere with diagnostic testing in febrile infants 2

While some sources suggest fluoroquinolones might be considered in specific situations 4, the FDA labeling and available evidence support avoiding levofloxacin during breastfeeding when safer alternatives are available.