title: Adverse reactions to contrast media: an analysis from spontaneous reporting data.
abstract: Diagnostic contrast media (CM) are a widely used class of drugs with poor information regarding their safety. Nevertheless, epidemiological studies showed that CM cause adverse reactions commonly considered unpreventable and unavoidable. Because spontaneous reporting is a valuable methodology for better defining the safety profile of drugs after their approval, we analyzed the spontaneous reports of suspected adverse reactions attributed to CM sent to the Sicilian Regional Centre for the Spontaneous Reporting of Adverse Drug Reactions (ADRs) during the period from 1996 to 2006, with the aim to identify their most important features. One hundred ADR reports out of 3471 involved CM (2.9%); 29 reports were serious, including 1 fatal case. Skin, respiratory system and gastrointestinal tract were most frequently affected sites. The majority of reports described hypersensitivity reactions with immediate onset. Iopromide (52.5%), iopamidol (13.9%) and iomeprol (11.9%) were the drugs with the highest number of reports. Case reports collected by the Sicilian Regional Centre showed that CM adverse reactions are not common or not commonly signalled; however, in agreement with previous published reports, analysis of data suggests that they are generally allergic-like reactions. Further investigations are needed within post-marketing surveillance to identify and prevent the consequences of CM adverse reactions and interactions. Awareness about CM safety should be promoted among all healthcare professionals.
authors.affiliation: Department of Clinical and Experimental Medicine and Pharmacology, School of Medicine, University of Messina, Italy. pmcutroneo@unime.it
authors.forename: Paola
authors.initials: P
authors.lastname: Cutroneo
authors.forename: Giovanni
authors.initials: G
authors.lastname: Polimeni
authors.forename: Roberto
authors.initials: R
authors.lastname: Curcuruto
authors.forename: Gioacchino
authors.initials: G
authors.lastname: Calapai
authors.forename: Achille P
authors.initials: AP
authors.lastname: Caputi
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D003287:Contrast Media / Q000009:adverse effects*; D004342:Drug Hypersensitivity / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000453:epidemiology / Q000209:etiology; D007472:Iohexol / Q000009:adverse effects / Q000031:analogs & derivatives; D007479:Iopamidol / Q000009:adverse effects / Q000031:analogs & derivatives; D008297:Male; D008875:Middle Aged; D012802:Sicily / Q000453:epidemiology
chemical_list: D003287:Contrast Media; C057937:iomeprol; D007472:Iohexol; C038192:iopromide; D007479:Iopamidol