title: Nexavar(®)-related adverse reactions: Calabrian (Italy) experience for sorafenib exposition in 2012.
abstract: Hepatocellular carcinoma (HCC) remains a major global health problem and Calabria in the south of Italy is not an exception. Sorafenib is the first and only Food and Drug Administration approved drug for the treatment of advanced HCC and it is currently under intensive monitoring by the Health Authorities in Italy Agenzia Italiana del Farmaco. This general report has been developed with the aim of briefly reviewing the data found in the reports of adverse reactions (ADRs) collected in Calabria in 2012 for sorafenib treated patients. Extrapolated data have highlighted some differences between the adverse drug reactions reported in patients younger or older than 70 years and other important differences with the current approved leaflet. Several limitations might be present in data analysis form spontaneous reporting, however, the relevance of reporting ADRs (dermatitis, asthenia, vomiting, etc.) for the early identification of drug related signals has to be underlined.
authors.affiliation: Department of Science of Health, School of Medicine, University of Catanzaro, Italy ; Department of Science of Health, Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Italy.
authors.forename: Felisa
authors.initials: F
authors.lastname: Cilurzo
authors.affiliation: Department of Science of Health, School of Medicine, University of Catanzaro, Italy ; Department of Science of Health, Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Italy.
authors.forename: Orietta
authors.initials: O
authors.lastname: Staltari
authors.affiliation: Department of Science of Health, School of Medicine, University of Catanzaro, Italy ; Department of Science of Health, Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Italy.
authors.forename: Marinella
authors.initials: M
authors.lastname: Patanè
authors.affiliation: Department of Medical and Surgery Science, University of Catanzaro, Magna Graecia, Medical School, Catanzaro, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Ammendola
authors.affiliation: Azienda Sanitaria Provinciale, Vibo Valentia, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Garaffo
authors.affiliation: Department of Science of Health, School of Medicine, University of Catanzaro, Italy ; Department of Science of Health, Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Italy.
authors.forename: Eugenio Donato
authors.initials: ED
authors.lastname: Di Paola
keywords: Adverse effects; hepatocellular carcinoma; pharmacovigilance; safety; sorafenib