title: Adverse reactions to oncologic drugs: spontaneous reporting and signal detection.
abstract: Oncology is one of the areas of medicine with the most active research being conducted on new drugs. New pharmacological entities frequently enter the clinical arena, and therefore, the safety profile of anticancer products deserves continuous monitoring. However, only very severe and (unusual) suspected adverse drug reactions (ADRs) are usually reported, since cancer patients develop ADRs very frequently and some practical selectivity must be used. Notably, a recent study was able to identify 76 serious ADRs reported in updated drug labels of oncologic drugs and 50% of them (n = 38) were potentially fatal. Of these, 49 and 58%, respectively, were not described in initial drug labels. The aims of this article are to provide an overview about spontaneous reporting of ADRs of oncologic drugs and to discuss the available methods to analyze the safety of anticancer drugs using databases of spontaneous ADR reporting.
authors.affiliation: Tuscan Regional Centre of Pharmacovigilance, Pisa, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Tuccori
authors.forename: Sabrina
authors.initials: S
authors.lastname: Montagnani
authors.forename: Alice
authors.initials: A
authors.lastname: Capogrosso-Sansone
authors.forename: Stefania
authors.initials: S
authors.lastname: Mantarro
authors.forename: Luca
authors.initials: L
authors.lastname: Antonioli
authors.forename: Matteo
authors.initials: M
authors.lastname: Fornai
authors.forename: Corrado
authors.initials: C
authors.lastname: Blandizzi
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents
keywords: adverse drug reaction; antineoplastic agent; oncology; pharmacovigilance; spontaneous reporting