Cutaneous adverse reactions to amoxicillin-clavulanic acid suspension in children: the role of sodium benzoate
| Autor: | Maria Elisabetta Rossi, Neri Pucci, Maurizio de Martino, Simona Barni, Francesca Mori, Elio Novembre |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Male
Preservative Time Factors Urticaria medicine.drug_class Provocation test Antibiotics Pharmacology Toxicology Placebo Amoxicillin-Potassium Clavulanate Combination chemistry.chemical_compound Suspensions Recurrence Clavulanic acid Sodium Benzoate medicine Humans Pharmacology (medical) Single-Blind Method Child Amoxicillin/clavulanic acid business.industry Preservatives Pharmaceutical Amoxicillin Anti-Bacterial Agents chemistry Child Preschool Sodium benzoate Female Drug Eruptions business medicine.drug |
| Zdroj: | Current drug safety. 7(2) |
| ISSN: | 2212-3911 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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