Is levofloxacin (fluoroquinolone antibiotic) safe to use during breastfeeding?

Levofloxacin During Breastfeeding

Levofloxacin can be used during breastfeeding when clinically indicated, though it is not a first-line choice; if a fluoroquinolone is necessary, the benefits typically justify the low risk of adverse effects to the nursing infant, and breastfeeding should not be interrupted. 1, 2

Safety Profile and Risk Assessment

Excretion into Breast Milk

• Levofloxacin is presumed to be excreted in human milk based on data from other fluoroquinolones, though direct data on levofloxacin specifically is very limited. 3
• The FDA label states that "a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother," reflecting regulatory caution rather than documented infant harm. 3

Theoretical Concerns vs. Clinical Evidence

• Theoretical concern: Fluoroquinolones have been associated with cartilage damage in juvenile animals, raising concerns about effects on developing infants. 4, 2
• Clinical reality: Despite these theoretical concerns, available human data from exposed pregnancies and breastfeeding have not confirmed these fears, and the risk of adverse effects is considered low. 5, 1
• With the exception of chloramphenicol, antibiotics including fluoroquinolones are generally considered compatible with breastfeeding when appropriately indicated. 2

Clinical Decision Algorithm

First-Line Antibiotics (Preferred During Breastfeeding)

• Penicillins (e.g., amoxicillin) and cephalosporins (e.g., cefuroxime) are considered compatible with breastfeeding and should be used preferentially. 6, 4
• Macrolides (e.g., azithromycin) are probably safe, though there is a very low risk of hypertrophic pyloric stenosis if used during the first 13 days of breastfeeding. 6, 4

Second-Line Consideration (When First-Line Options Fail)

• If fluoroquinolones are clinically indicated (e.g., resistant organisms, drug intolerance, serious infections like plague or anthrax), they should not be withheld, and breastfeeding should not be interrupted because the risks are justified by the benefits. 1, 2
• Ciprofloxacin is the preferred fluoroquinolone within this class during breastfeeding due to more extensive safety data compared to levofloxacin or other fluoroquinolones. 6, 4
• Levofloxacin can be used when ciprofloxacin is not appropriate for the specific infection (e.g., certain drug-resistant tuberculosis). 6

When Levofloxacin is Specifically Indicated

• Levofloxacin is appropriate for lactating mothers requiring treatment for plague, including as postexposure prophylaxis, at a dose of 10 mg/kg every 12 hours orally. 6
• For drug-resistant tuberculosis when first-line agents cannot be used, levofloxacin (500-1,000 mg daily) is the preferred oral fluoroquinolone based on its good safety profile with long-term use. 6

Important Considerations and Pitfalls

Bioavailability Concerns

• Critical pitfall: Oral fluoroquinolones, including levofloxacin, have reduced bioavailability when co-ingested with milk due to calcium and other minerals that inhibit absorption. 6
• Practical solution: While this affects the mother's absorption if she takes the medication with milk, the infant's exposure through breast milk remains low and is not considered a contraindication to breastfeeding. 6

Potential Infant Effects

• 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. 6, 4
• These effects are generally mild and do not outweigh the benefits of continued breastfeeding. 4

Medication Timing

• Levofloxacin should not be administered within 2 hours of antacids or other medications containing divalent cations (magnesium, aluminum, iron, zinc) as these significantly decrease absorption. 6, 7

Balancing Maternal Treatment with Infant Safety

The protective effects of breastfeeding—including maternal-infant bonding, ideal nutrition, and immunologic benefits—must be balanced against the low theoretical risk of fluoroquinolone exposure. 6

• Breastfeeding has many benefits including boosting of the immune system via immunoglobulins, cytokines, probiotic bacteria, and other protective immunologic factors contained in breast milk. 6
• The benefits of continued breastfeeding far outweigh the minimal theoretical risks of antibiotic exposure through breast milk, and premature cessation of breastfeeding due to unnecessary concerns about antibiotics causes more harm. 4
• Most antibiotics in clinical use, including fluoroquinolones when indicated, are considered suitable during breastfeeding when the pharmacokinetic profile and clinical necessity are appropriately considered. 8