Adverse drugs reactions to paracetamol and ibuprofen in children: a 5-year report from a pediatric poison control center in Italy

Our study shows that younger children are at risk of taking an inappropriate dose of paracetamol or ibuprofen, mainly due to wrong or accidental administration by parents at home. These events mostly lead to telephone contact with the PPCC and, in one-third of cases (34.5%), direct referral to the emergency department. However, suicidal intent was traced in one-fifth of cases (21.1%). Only a minority of patients were symptomatic (7.4%), with equal incidences between the paracetamol and ibuprofen cohorts. Correspondingly, most patients were evaluated as mildly (78.3%) or not intoxicated (70.4%). Only less than a third of patients required hospitalization (30.5%). However, 40.2% of these were just observed briefly after ED admission and then discharged.

In the overall cohort, 37 adverse reactions were recorded (10.5%), occurring equally in the paracetamol and ibuprofen cohorts. The most common adverse reactions in children taking either paracetamol or ibuprofen were gastrointestinal in nature: nausea and vomiting in both cases being the most representative symptoms.

Comparison of children who took paracetamol or ibuprofen showed that the former was more frequently associated with wrong use (p = 0.021) and suicidal intent (p = 0.008) and less frequently with accidental intake (p < 0.001). Intake of paracetamol was also more frequently associated with a moderate (p = 0.001), rather than a mild (p = 0.001) intoxication, compared to ibuprofen. This may be due to the more frequent suicidal intent behind paracetamol use, both due to local popularity and greater availability of this over-the-counter drug at home. More specifically, as most Italian pediatricians are aware of the risk linked to inappropriate use of paracetamol and ibuprofen, correctly indicating the former as first choice against fever [12], the commonly reported wrong use of paracetamol is probably due to an inappropriate autonomous administration. Moreover, the toxic dose of ibuprofen is higher than that of paracetamol, and requires greater availability of the product at home [13]. In particular, an oral dose of 200 mg/kg (or 12 g) of paracetamol is considered toxic [14], while a dose of 400 mg/kg is required for ibuprofen-mediated toxicity [15].

The COVID-19 pandemic caused a surge in neuropsychiatric disorders among children, with a parallel increase in suicide attempts, as demonstrated in our study, consistently with other reports [16, 17]. Our results are self-explanatory: children with suicidal intent were older and more likely to experience drug adverse reactions and to be intoxicated, coherently with a higher intake of paracetamol and ibuprofen. Interestingly, paracetamol assumption was more frequently associated with suicidal intent than ibuprofen, probably owing to the widespread availability of paracetamol and the known severe hepatotoxicity associated with its use.

The distribution of cases in trimesters showed a remarkable increase during the last trimester of 2021 and first trimester of 2022. It is difficult to address this increase, but a possible link to the recent pandemic and, more specifically, to the broad reduction of preventive measures after the successful vaccination campaign against COVID-19 cannot be ruled out. Moreover, the increased availability of these drugs at home, purchased during the pandemic to alleviate the symptoms of COVID-19, may have contributed to their uncontrolled self-administration.

Our article is limited by its retrospective nature and lack of definition of weight-adjusted doses and, therefore, toxicity levels. However, it contributes to the safety profiling of drugs widely used in pediatrics, such as paracetamol and ibuprofen, by providing real-world data.

留言 (0)

沒有登入
gif