Drug Induced Liver Injury

• Autor(a) principal: Nunes, David Ricardo da Conceição Marçal Alves
• Data de Publicação: 2021
• Tipo de documento: Dissertação
• Idioma: eng
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10400.6/11324
• topic: Código Químico Terapêutico Anatómico; Farmacovigilância; Lesão Hepática Induzida Por Medicamentos; Número de Medicamentos Suspeitos; Reacções Adversas A Medicamentos; Domínio/Área Científica::Ciências Médicas::Ciências da Saúde::Medicina

The pharmacovigilance system has as its functions the detection, registry and assessment of adverse drug reactions (ADRs). Adverse drug reactions have a high morbimortality and certain ADRs are only apparent during phase IV of drug development. For that reason, it is vital that ADRs are notified to the Pharmacovigilance systems. Drug induced liver injury (DILI), can be caused by drugs, herbal products and food supplements. The spectrum of clinical presentations of DILI is wide, from asymptomatic patients with only elevation of liver enzymes to acute liver failure. Unfortunately, there are not known biomarkers. Rendering DILI as a diagnosis of exclusion. DILI is the main reason of new drugs non approval, black boxes warnings and withdrawn from the market. This topic is important not only to health professional but also to the pharmaceutical industry. This retrospective study analysed the reports sent to the Portuguese Pharmacovigilance system in a 10-year period from January 2010 to December 2019. A total of 2038 reports with at least 1 liver related RAM were analysed. There was not a prevalence of either sex in any age group. Most reports (n=1120, 55.0%) belonged to patients in age group 19-64 years old. Age group 1-3 years had the lowest number of reports (n=21, 1.0%). Hepatitis (n=626, 26.7%) was the most common RAM in our study. Hepatotoxicity (n=362, 15.5%) and hepatitis (n=333, 14.2%) were more frequent in age group 19-64 years old. Cholestasis was more prevalent in adults independently of age. Hepatic fibrosis and encephalopathy were more common in the elderly. The causality assessment was not performed in 1303 cases (71.3%) and category “definitive” (n=24, 1.3%) had a low prevalence. Most patients consumed between 1-4 suspected drugs (n=1867, 92%). Most patients in our study evolved to “cure” (n=796; 39%). Hepatitis (n=610; 25.9%), hepatotoxicity (n=489; 20.8%) and jaundice (n=260; 11.0%) were more common in patients who took 1-4 suspected drugs. Hepatic fibrosis (n=55; 2.3%) was more frequent in who consumed 5-9 suspected drugs. Hepatotoxicity (n=23; 13.8%) and hepatitis (n=610; 25.9%) had a female predominancy while choluria (n=8; 4.8%) and splenomegaly (n=8; 4.8%) were of male predominance. In conclusion, although DILI is a rare occurrence, it can be serious and even fatal. Our study highlights the need for more efforts to assess causality. More studies concerning DILI are needed in Portugal.