title: Linezolid-associated peripheral and optic neuropathy in children.
abstract: OBJECTIVE
  Peripheral neuropathy (PN) and optic neuropathy (ON) associated with linezolid use are described in the adult literature; however limited information is available in pediatrics. The purpose of this communication is to summarize pediatric cases of linezolid-associated neuropathy and to increase awareness of these neurologic side effects so that clinicians can most appropriately balance the benefits and risks of linezolid in the pediatric population.
  
  
  METHODS
  A search of the FDA Adverse Events Reporting System was performed for all pediatric cases of neuropathy from April 2000-2009. AERS includes both inpatient and outpatient data. Inpatient utilization patterns for linezolid were also assessed from January 2000 to December 2008.
  
  
  RESULTS
  Eight pediatric cases of linezolid-associated neuropathy were identified. Treatment duration ranged from 4 weeks to 1 year. Five patients had PN alone, one had only ON and two had both. Symptoms of PN included pain, numbness, weakness, and paresthesias. Symptoms of ON included decreased visual acuity and color vision. Three children had other adverse events associated with linezolid including acidosis, anemia, and leukopenia. Outcomes were reported in 5 cases. Resolution of symptoms occurred between 2 weeks and 6 months after discontinuation of linezolid. Utilization data showed that during the study period, overall inpatient utilization of linezolid had increased.
  
  
  CONCLUSIONS
  While linezolid may be used to treat serious infections often needing extended courses of therapy, potential safety concerns should be kept in mind. In the circumstance of prolonged use of linezolid in children, it is likely that more cases of neuropathy may occur.
authors.affiliation: fﬁce of New Drugs, Ofﬁce of Antimicrobial Products, US Food and Drug Administration, Silver Spring, MD 20993, USA. sumathi.nambiar@fda.hhs.gov
authors.forename: Sumathi
authors.initials: S
authors.lastname: Nambiar
authors.forename: Neil
authors.initials: N
authors.lastname: Rellosa
authors.forename: Ronald T
authors.initials: RT
authors.lastname: Wassel
authors.forename: Vicky
authors.initials: V
authors.lastname: Borders-Hemphill
authors.forename: John S
authors.initials: JS
authors.lastname: Bradley
mesh_terms: D000081:Acetamides / Q000009:adverse effects*; D000293:Adolescent; D000890:Anti-Infective Agents / Q000009:adverse effects; D001118:Argentina / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D007239:Infections / Q000188:drug therapy; D000069349:Linezolid; D008297:Male; D009901:Optic Nerve Diseases / Q000139:chemically induced* / Q000453:epidemiology; D023303:Oxazolidinones / Q000009:adverse effects*; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced* / Q000453:epidemiology; D012307:Risk Factors
chemical_list: D000081:Acetamides; D000890:Anti-Infective Agents; D023303:Oxazolidinones; D000069349:Linezolid