Pscribe: a Pharmacotherapy E-learning Web-application enabling registration and mapping of the rational drug-choice process of students and experts

Abstract

e46 Volume 37 Number 8S Background or Introduction: Amoxicillin alone and with clavulanic acid are among the most prescribing antibacterial agents in Italy. These drugs are generally well tolerated and usually prescribed by paediatrics, although published studies indicate that they are frequently associated with adverse drug reactions (ADRs), in particular cutaneous and gastrointestinal ones. We analyzed the Italian database of spontaneous reporting of suspected ADRs in order to compare the safety profile of amoxicillin and amoxicillin/clavulanic acid (amoxiclav) in pediatrics. Material and Methods: Reports of suspected ADRs due to amoxicillin and amoxi-clav in pediatric patients, until 1 September 2014, were extracted. ADRs were coded using MedDRA terminology. To evaluate the correlation between drug use and occurrence of ADRs a disproportionality analysis through Reporting Odds Ratio (ROR) was performed. Results: We collected 3.345 reports associated with amoxicillin and amoxicillin/clavulanic acid, 1.188 (35.5%) related to amoxicillin and 2.157 (64.5%) to amoxicillin with clavulanic acid. The percentages of serious ADRs were 12% for amoxicillin and 16% for amoxi-clav. The percentage of skin reactions was higher for amoxicillin (75%) than for amoxicillin/clavulanic acid (67%) and for gastrointestinal reactions was higher for amoxicillin/clavulanic acid (16%) than for amoxicillin (10%). For amoxicillin, significant disproportionality was observed only for cutaneous ADR like dermatitis (ROR, 2.31; 95% CI, 1.26–4.25), rash (1.30; 1.08–1.57), erythematous rash (1.70; 1.18–2.45). For amoxicillin/clavulanic acid was observed only for gastrointestinal ADR: diarrhoea (1.56; 1.15–2.12), abdominal pain (2.11; 1.14–3.93) and sickness (1.69; 1.20–2.38). Conclusions: Our analysis shows a different safety profile for amoxicillin and amoxi-clav in paediatrics: the first is associated with an higher risk of skin reactions while the amoxi-clav with gastrointestinal ones. Nevertheless, data did not reveal an increased risk of liver damage from clavulanic acid than amoxicillin alone, as widely reported in literature.