Cutaneous Adverse Reactions to Amoxicillin-Clavulanic Acid Suspension in Children: The Role of Sodium Benzoate

Francesca      Mori; Simona      Barni; Neri      Pucci; Maria      Elisabetta Rossi; Maurizio      de Martino; Elio      Novembre

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.

Study Design: 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).

Conclusion: Sodium benzoate probably acts through a non-immunologic mechanism and care should be given to children allergic to sodium benzoate containing pharmaceutical formulations.

Keywords: Amoxicillin, clavulanic acid allergy, children, drug induced-diseases, excipient, sodium benzoate.

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