Is moxifloxacin (a fluoroquinolone antibiotic) safe for use in pediatric patients?

Moxifloxacin Use in Pediatric Patients

Moxifloxacin is contraindicated in children and adolescents under 18 years of age and should not be used in this population. 1, 2

Regulatory Status and Contraindications

• The FDA has not approved moxifloxacin for pediatric use, and effectiveness in patients under 18 years has not been established 2
• The British Thoracic Society explicitly contraindicates moxifloxacin in children and growing adolescents due to arthropathy development in weight-bearing joints observed in young animals 1
• The FDA drug label states that moxifloxacin causes arthropathy in juvenile animals, which forms the basis for its contraindication in pediatric patients 2

Evidence of Harm in Pediatric Populations

Musculoskeletal Toxicity

• Animal studies demonstrate that fluoroquinolones, including moxifloxacin, cause damage to developing cartilage and weight-bearing joints 1, 2
• While the exact risk in humans remains uncertain, the American Academy of Pediatrics notes that fluoroquinolones have been associated with musculoskeletal adverse events in children, with arthralgia/arthritis documented in pediatric patients 1
• The potential for sustained injury to developing joints in humans has not been excluded, even if it occurs infrequently 1

Clinical Trial Data

• A large randomized controlled trial (MOXIPEDIA) in 451 pediatric patients with complicated intra-abdominal infections demonstrated inferior efficacy with moxifloxacin (84.6% cure rate) compared to ertapenem/amoxicillin-clavulanate (95.5% cure rate) 3
• This study concluded that moxifloxacin should not be recommended for children when alternative more efficacious antibiotics with better safety profiles are available 3
• Drug-related adverse events occurred in 14.3% of moxifloxacin-treated children versus 6.7% in the comparator group 3

Limited Exceptions for Tuberculosis Only

• The only potential exception is for tuberculosis treatment in children with multidrug-resistant organisms, where the American Thoracic Society/CDC/IDSA acknowledges that fluoroquinolones may be considered with extreme caution 1
• Even in this context, long-term use (more than several weeks) has not been approved due to concerns about bone and cartilage growth effects 1
• The optimal pediatric dose for moxifloxacin is unknown, as there are no data to support any dosing regimen in children 1

Additional Safety Concerns in Pediatric Use

Cardiac Toxicity

• Moxifloxacin carries risk of QTc prolongation, which may be particularly concerning in pediatric patients 1, 2
• The drug should not be used in patients with congenital or acquired QT prolongation, clinically relevant bradycardia, or electrolyte disturbances 1

Central Nervous System Effects

• Seizures and other CNS adverse effects can occur, with particular concern in pediatric populations 2
• CNS side effects may occur after the first dose and include seizures, hallucinations, confusion, and anxiety 2

Tendon Damage

• Tendon inflammation and rupture can occur within 48 hours of treatment or several months after stopping, with increased risk in patients on corticosteroids 1, 2

Comparison with Other Fluoroquinolones

• Ciprofloxacin and levofloxacin have more established pediatric safety data and FDA approval for specific indications (complicated urinary tract infections for ciprofloxacin; inhalational anthrax post-exposure for both) 1, 4
• The American Academy of Pediatrics recommends that if a fluoroquinolone is absolutely necessary, ciprofloxacin or levofloxacin should be chosen over moxifloxacin due to better-characterized safety profiles 1, 4
• Even for these agents, use should be restricted to situations where infection is caused by multidrug-resistant pathogens with no safe alternative, or when parenteral therapy is not feasible and no other effective oral agent exists 1, 4

Clinical Bottom Line

Do not prescribe moxifloxacin to pediatric patients. The drug is contraindicated in this population due to arthropathy risk in developing joints, lack of established efficacy, inferior clinical outcomes compared to alternatives, and absence of FDA approval for any pediatric indication 1, 2, 3. If a fluoroquinolone is absolutely required for a life-threatening multidrug-resistant infection with no alternatives, choose ciprofloxacin or levofloxacin instead, which have more pediatric safety data and FDA approval for limited indications 1, 4.