RESUMO
OBJECTIVE: Excipients used in oral or intravenous preparations may cause serious adverse events. CASE SUMMARY: We present the case of a 15-year-old boy with hypertrophic cardiomyopathy. In the pediatric intensive care unit, he received high doses of continuous intravenous esmolol (range = 20-400 µg/kg/min) for cardiac rhythm control. After a few days he developed a delirium not responding to high doses of antipsychotics or discontinuation of benzodiazepines. We eventually realized that the IV esmolol formulation contained high doses of propylene glycol and ethanol, which may accumulate after prolonged infusion and cause intoxication. Intoxication with propylene glycolcan cause neuropsychiatric symptoms. The boy's propylene glycol plasma concentration was approximately 4 g/L, whereas clinical symptoms arise at concentrations above 1 to 1.44 g/L. Application of the Naranjo adverse drug reaction probability scale suggested a probable relationship (score 6) between the propylene glycol infusion and the delirium. After discontinuation of esmolol, the delirium disappeared spontaneously. DISCUSSION: This is the first case describing excipient toxicity of esmolol, with an objective causality assessment revealing a probable relationship for the adverse event-namely, delirium-and esmolol. CONCLUSION: Although excipient toxicity is a well-known adverse drug reaction, this case stresses the importance for easily available information for and education of physicians.
RESUMO
A full-term afebrile male infant was born with multiple sterile pustules, which easily ruptured to reveal an underlying erythematous skin. He was diagnosed with 'transient neonatal pustulosis', a benign self-limiting condition which disappears within a few days. However, hyperpigmented skin lesions (melanosis) may remain visible for several months.