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Linezolid-associated peripheral and optic neuropathy in children

Sumathi Nambiar1, Neil Rellosa, Ronald T Wassel

  • 1ffice of New Drugs, Office of Antimicrobial Products, US Food and Drug Administration, Silver Spring, MD 20993, USA. sumathi.nambiar@fda.hhs.gov

Pediatrics
|May 11, 2011
PubMed

Insights

Pediatric neuropathy, including peripheral neuropathy (PN) and optic neuropathy (ON), can occur with linezolid treatment. Increased awareness is crucial for balancing linezolid

Area of Science:

  • Pediatric Neurology
  • Pharmacovigilance
  • Infectious Diseases

Background:

  • Linezolid is an antibiotic used for serious infections.
  • Neurologic side effects, including peripheral neuropathy (PN) and optic neuropathy (ON), are known in adults but less documented in children.
  • Limited pediatric data necessitates further investigation into linezolid-associated neurotoxicity.

Purpose of the Study:

  • To summarize pediatric cases of linezolid-associated neuropathy.
  • To enhance clinician awareness of these neurologic adverse events in children.
  • To inform the risk-benefit assessment of linezolid in pediatric populations.

Main Methods:

  • Searched the FDA Adverse Events Reporting System (AERS) for pediatric neuropathy cases (2000-2009).
  • Analyzed inpatient linezolid utilization data (2000-2008).
  • Reviewed reported symptoms, treatment durations, and outcomes.

Main Results:

  • Identified eight pediatric cases of linezolid-associated neuropathy (PN, ON, or both).
  • Symptoms included pain, numbness, weakness, decreased visual acuity, and color vision changes.
  • Neuropathy resolution occurred within 2 weeks to 6 months after linezolid discontinuation; increased linezolid use was observed.

Conclusions:

  • Prolonged linezolid use in children may lead to an increased incidence of neuropathy.
  • Clinicians must consider potential neurotoxicity when prescribing linezolid for extended durations in pediatric patients.
  • Careful monitoring and risk-benefit evaluation are essential for safe linezolid use in children.
Abstract

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