Is Levofloxacin (fluoroquinolone antibiotic) safe for use in infants under 6 months of age?

Levofloxacin Safety in Infants Under 6 Months of Age

Levofloxacin is not recommended for use in infants under 6 months of age due to safety concerns regarding potential cartilage toxicity, with no established safety data in this age group. 1

Safety Concerns and FDA Labeling

• The FDA label explicitly states that "safety and effectiveness in pediatric patients below the age of six months have not been established" for levofloxacin 1
• Fluoroquinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals of several species 1
• Fluoroquinolones have historically been contraindicated in pediatric populations due to concerns about effects on bone and cartilage growth observed in juvenile animal studies 2

Limited Approved Indications in Pediatrics

• In children 6 months and older, levofloxacin is only FDA-approved for:
  • Inhalational anthrax (post-exposure) 1
  • Plague treatment and prophylaxis 1
• These approvals were granted only after careful risk-benefit assessment determined that administration was appropriate in these specific life-threatening scenarios 1

Musculoskeletal Safety Concerns

• In clinical trials with children aged 6 months to 16 years, levofloxacin-treated patients showed a significantly higher incidence of musculoskeletal disorders compared to non-fluoroquinolone treated children 1
• Specific musculoskeletal adverse events documented in levofloxacin-treated children include:
  • Arthralgia (most common) 1, 3
  • Arthritis 1
  • Tendinopathy 1
  • Gait abnormality 1
• The incidence of these disorders was statistically greater in levofloxacin-treated children compared to those treated with non-fluoroquinolone antibiotics at both 2 months (2.1% vs. 0.9%) and 12 months (3.4% vs. 1.8%) after therapy 3

Pharmacokinetic Considerations

• Children younger than 5 years clear levofloxacin nearly twice as fast as adults 4
• This altered pharmacokinetic profile means infants and young children would require different dosing regimens to achieve therapeutic levels 4
• For children 6 months to <5 years, a dosing regimen of 10 mg/kg every 12 hours has been studied 4

Long-Term Safety Data

• A 5-year follow-up safety study of children previously treated with levofloxacin found that long-term musculoskeletal adverse events were uncommon or clinically undetectable 5
• However, this study did not include infants under 6 months of age 5

Alternative Treatments for Infants

• For treatment of infections in infants under 6 months, guidelines recommend using established antibiotics with well-documented safety profiles in this age group 2
• For pneumococcal infections, including resistant strains, preferred treatments include:
  • Ampicillin (150-200 mg/kg/day) 2
  • Penicillin (200,000-250,000 U/kg/day) 2
  • Ceftriaxone (50-100 mg/kg/day) 2
  • Cefotaxime (150 mg/kg/day) 2

Conclusion

Given the lack of established safety data, potential for musculoskeletal adverse effects, and availability of alternative antibiotics with better safety profiles in this age group, levofloxacin should not be used in infants under 6 months of age except in extraordinary circumstances where no alternative exists and the benefit clearly outweighs the potential risks 2, 1.