Reações adversas a medicamento sem pacientes hospitalizados por insuficiência hepática crônica moderada ou grave em hospitais do Nordeste do Brasil

Abstract

Chronic liver failure (CLF) is characterized by progressive and irreversible loss of liver function, which may lead to alterations in the pharmacokinetics of various medications and increased susceptibility to adverse drug reactions (ADRs). In this context, the clinical pharmacist plays a fundamental role in the prevention, identification, and management of these reactions. This study aimed to characterize the incidence, determinants, and clinical relevance of ADRs in patients hospitalized with moderate to severe CLF in hospitals in the Northeast region of Brazil. This is an observational, analytical, multicenter prospective cohort study that included patients with moderate to severe CLF (Child-Pugh B or C) hospitalized in seven hospitals in Northeast Brazil between September 2023 and January 2026. Daily collection of clinical, laboratory, and pharmacotherapeutic data was performed, with active surveillance of ADRs through medical record review, trigger tools, and reports from the healthcare team and patients. ADRs were coded according to the Medical Dictionary for Regulatory Activities (MedDRA®) and classified regarding causality, severity, and preventability using validated tools. Data analysis was performed using Stata 15®, adopting a significance level of p < 0.05. A total of 252 patients were included, with a predominance of males (59.1%) and a mean age of 59.2 years. Overall, 38.9% of patients experienced at least one ADR, totaling 207 events. The most frequent ADRs involved gastrointestinal, nervous system, and metabolic disorders, with furosemide, lactulose, and carvedilol identified as the main suspected drugs. Most ADRs were classified as probable or possible, of mild severity, and largely preventable. ADRs were associated with longer follow-up time, previous upper gastrointestinal bleeding, and laboratory abnormalities suggestive of hepatic and renal dysfunction, such as elevated urea, bilirubin, and aspartate aminotransferase (AST), as well as hyponatremia. ADRs were also associated with relevant clinical outcomes, including hepatorenal syndrome, prophylactic variceal ligation, acute-on-chronic liver failure, jaundice, and hepatic coma. In conclusion, ADRs are frequent in patients with CLF, many of which are preventable, and are associated with worse clinical outcomes, highlighting the need for rigorous pharmacotherapeutic monitoring and strategies to ensure safe medication use in this population.