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Journal of Pharmacology and PharmacotherapeuticsNOW IN
Article

Nexavar®-related adverse reactions: Calabrian (Italy) experience for sorafenib exposition in 2012

Felisa Cilurzo1, Orietta Staltari2, Marinella Patanè3, Michele Ammendola4, Caterina Garaffo4, Eugenio Donato Paola4★★ Corresponding author

  1. 1Department of Science of Health, School of Medicine, University of Catanzaro, Catanzaro, Italy.
  2. 2Department of Science of Health, Pharmacovigilance’s Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
  3. 3Department of Medical and Surgery Science, University of Catanzaro, Magna Graecia, Medical School, Catanzaro, Italy.
  4. 4Azienda Sanitaria Provinciale, Vibo Valentia, Italy.

CORRESPONDENCE

Eugenio Donato Paola

Eugenio Donato Di Paola,Azienda Sanitaria Provinciale, Vibo Valentia, Italy.

dipaola@unicz.it

Volume 4, Issue 4S · pp. S86–S86 · PUBLISHED 2013 · DOI: 10.4103/0976-500X.120971

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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.

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    Cilurzo, F., Staltari, O., Patanè, M., Ammendola, M., Garaffo, C., & Paola, E. D. (2013). Nexavar®-related adverse reactions: Calabrian (Italy) experience for sorafenib exposition in 2012. Journal of Pharmacology and Pharmacotherapeutics, 4(4S), S86–S86. https://doi.org/10.4103/0976-500X.120971