title: Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance.
abstract: OBJECTIVE
  During the last years in Italy, contrast media (CM) use increased. An increase of monitoring activities on CM-induced adverse drug reaction (ADR) is necessary, also in our regional territory. The main aim of this study was to give a preliminary evaluation of all Spontaneous Reports of ADRs (SRA) attributed to CM sent to Campania Pharmacovigilance Regional Center (CRFVC) from 01 January 2001 to 31 October 2014.
  
  
  METHODS
  For each SRA we evaluated: frequency and source, ADRs onset (time to event, seriousness and outcome), socio-demographic characteristics and risk factors of cases, the most reported CM (checking for pharmacodynamic and pharmacokinetic interactions).
  
  
  RESULTS
  A total of 111 SRA were sent to CRFVC; specialist in radiology was the main source of reports. Ninety-seven SRA (87.3%) were referable to hypersensitivity reactions. Thirty-four SRA (30.6%) reported serious ADRs. The most reported CM were iopamidol, gadobenic acid and gadoteric acid. We identified two SRA induced by pharmacokinetic and/or pharmacodynamic interactions.
  
  
  CONCLUSIONS
  During 14 years of post-marketing surveillance, only few SRA concerning CM-induced ADRs were sent to CRFVC probably due to underreporting. We aim to improve monitoring activity on CM-induced ADRs especially in hospitals. Most reported ADR and CM were in line with current body of literature.
authors.affiliation: a 1 Second University of Naples, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli , Naples, Italy +39 0815667652 ; +39 0815667652 ; maurizio.sessa@unina2.it.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Sessa
authors.forename: Claudia
authors.initials: C
authors.lastname: Rossi
authors.forename: Annamaria
authors.initials: A
authors.lastname: Mascolo
authors.forename: Enrico
authors.initials: E
authors.lastname: Grassi
authors.forename: Sonia
authors.initials: S
authors.lastname: Fiorentino
authors.forename: Cristina
authors.initials: C
authors.lastname: Scavone
authors.forename: Alfonso
authors.initials: A
authors.lastname: Reginelli
authors.forename: Antonio
authors.initials: A
authors.lastname: Rotondo
authors.forename: Liberata
authors.initials: L
authors.lastname: Sportiello
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing; D055815:Young Adult
chemical_list: D003287:Contrast Media
keywords: adverse drug reactions; breakthrough reaction; contrast media; pharmacovigilance; preventable contrast media reactions; spontaneous reporting system