Levofloxacin Safety During Breastfeeding
Levofloxacin should not be used as a first-line antibiotic during breastfeeding, but if clinically indicated when safer alternatives are inadequate, breastfeeding does not need to be discontinued due to the very low levels present in breast milk and absence of documented harm in breastfed infants. 1, 2
Primary Recommendation
Fluoroquinolones, including levofloxacin, should be avoided as first-line treatment during breastfeeding due to theoretical concerns about cartilage damage based on animal studies, though these effects have not been observed in clinical practice with the low concentrations present in breast milk. 1, 2
If a fluoroquinolone is clinically necessary and safer alternatives are not appropriate, ciprofloxacin is the preferred agent in this class rather than levofloxacin, as it has more extensive safety data during breastfeeding. 1, 3, 4
However, fluoroquinolones are present in breast milk at concentrations two orders of magnitude lower than therapeutic infant doses, and absorption is further reduced by the high calcium content in breast milk which inhibits fluoroquinolone absorption. 3, 4
FDA Drug Label Position
The FDA label states that levofloxacin is presumed to be excreted in human milk based on data from other fluoroquinolones and very limited data on levofloxacin itself. 5
A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother, due to potential for serious adverse reactions in nursing infants. 5
The FDA label does not provide definitive safety data but emphasizes caution. 5
Evidence-Based Clinical Context
Most antibiotics, including fluoroquinolones, are considered compatible with breastfeeding when used appropriately, with the understanding that theoretical risks must be weighed against clinical necessity. 2
A 2022 systematic review concluded that data from exposed pregnancies and breastfeeding have not confirmed the joint toxicity fears seen with direct pediatric treatment, and fluoroquinolones can be considered when clearly indicated. 6
With the exception of chloramphenicol, antibiotics including fluoroquinolones are considered compatible with breastfeeding based on comprehensive safety reviews. 7
Preferred Safer Alternatives (Use These First)
Penicillins (amoxicillin, ampicillin) are the first-line choice and are considered low risk and compatible with breastfeeding. 1, 4, 2
Cephalosporins (cefuroxime, ceftriaxone, cefadroxil) have low oral bioavailability in infants and are compatible with breastfeeding. 1, 4
Macrolides (azithromycin, erythromycin) carry very low risk of hypertrophic pyloric stenosis only if used during the first 13 days of breastfeeding and are safe after 2 weeks. 1
Amoxicillin/clavulanic acid is a safe and effective choice with FDA Category B rating. 1
When Levofloxacin Must Be Used
Breastfeeding can be timed to correspond with the lowest concentration in breast milk, which occurs 3-4 hours after each maternal dose to minimize infant exposure. 3, 4
Monitor all breastfed infants for gastrointestinal effects such as diarrhea and altered intestinal flora when the mother receives any antibiotic. 1, 4
Be aware that antibiotics in breast milk may cause falsely negative cultures if a febrile infant requires evaluation. 1, 3, 4
Critical Caveats
The theoretical cartilage damage concern is based on animal studies and direct pediatric treatment data, not on breastfeeding exposure where drug levels are substantially lower. 1, 3, 2
Human data suggest low risk when fluoroquinolones are used during breastfeeding despite theoretical concerns. 3, 4
The decision should prioritize treating the mother's infection adequately while using the safest effective antibiotic available. 5, 2