Assuntos
Anticoagulantes/efeitos adversos , Sistema Nervoso Central/efeitos dos fármacos , Trato Gastrointestinal/efeitos dos fármacos , Hemorragia/epidemiologia , Farmacovigilância , Vitamina K/antagonistas & inibidores , Bases de Dados Factuais , França/epidemiologia , Hemorragia/induzido quimicamente , HumanosRESUMO
PURPOSE: Identify the main pharmacological classes inducing pancreatitis using spontaneous reports recorded in the French pharmacovigilance database (FPVD). METHODS: Cases of pancreatitis recorded in FPVD between January 1st 1985 and December 31st 2013 were selected using the 2001 consensus conference criteria of the French High Health Authority. RESULTS: During this period, 2975 observations were selected with 1151 fulfilling criteria of drug-induced pancreatitis (i.e. 0.22% of total notifications in the FPVD). According to ATC classification, the pharmacological classes most frequently found were antiretroviral, analgesic, lipid-lowering, immunosuppressive and insulin secreting drugs. For some drugs (metformin, omeprazole, etc.) pancreatitis was "unlabelled" in the summary of product characteristics. CONCLUSION: This review allows to identify the main drug classes currently involved in spontaneous reporting of pancreatitis in France.