title: Cutaneous adverse reactions to amoxicillin-clavulanic acid suspension in children: the role of sodium benzoate.
abstract: BACKGROUND
  In Europe amoxicillin plus clavulanic acid is the most commonly prescribed antibiotic and sodium benzoate is contained in the suspension formulation as a preservative.
  
  
  OBJECTIVE
  We studied the relevance of sodium benzoate as the culprit agent. In a group of children with a history of adverse reactions to amoxicillin plus clavulanic acid suspension.
  
  
  METHODS
  A total of 89 children were enrolled over a period of 3 years (2006 - 2009). Single blind oral provocation tests (OPTs) with amoxicillin plus clavulanic acid, sodium benzoate and placebo were performed. 20 children with recurrent idiopathic urticaria were investigated as a control group.
  
  
  RESULTS
  according to personal history: 70% of reactions were late in developing while 23% of reactions were immediate and for 5% of the cases it was not possible to define the timing. 8 children (8/89=9%) resulted positive to the provocation tests with amoxicillin plus clavulanic acid; ten children (10/89=11%) had positive results with sodium benzoate; 3% had a double positivity (i.e. excipient and active drug). The timing of reactions significantly differs between the Amoxicillin plus clavulanic acid and sodium benzoate groups (p=0.002).
  
  
  CONCLUSIONS
  Sodium benzoate probably acts through a non-immunologic mechanism and care should be given to children allergic to sodium benzoate containing pharmaceutical formulations.
authors.affiliation: Allergy and Clinical Immunological Unit, A. Meyer Children’s Hospital, Department of Pediatrics, University of Florence, Italy. f.mori@meyer.it
authors.forename: Francesca
authors.initials: F
authors.lastname: Mori
authors.forename: Simona
authors.initials: S
authors.lastname: Barni
authors.forename: Neri
authors.initials: N
authors.lastname: Pucci
authors.forename: Maria Elisabetta
authors.initials: ME
authors.lastname: Rossi
authors.forename: Maurizio
authors.initials: M
authors.lastname: de Martino
authors.forename: Elio
authors.initials: E
authors.lastname: Novembre
mesh_terms: D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000009:adverse effects*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D003875:Drug Eruptions / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects / Q000737:chemistry; D012008:Recurrence; D016037:Single-Blind Method; D020160:Sodium Benzoate / Q000009:adverse effects* / Q000737:chemistry; D013535:Suspensions; D013997:Time Factors; D014581:Urticaria / Q000139:chemically induced*
chemical_list: D000900:Anti-Bacterial Agents; D011310:Preservatives, Pharmaceutical; D013535:Suspensions; D019980:Amoxicillin-Potassium Clavulanate Combination; D020160:Sodium Benzoate