title: Acute adverse reactions to iopromide vs iomeprol: a retrospective analysis of spontaneous reporting from a radiology department.
abstract: OBJECTIVE
  To compare the safety of iopromide and iomeprol use in a hospital that switched from the former to the latter and found an apparent increase in the number (and a different profile) of adverse reactions reported for iomeprol, putting the safety of its use into question.
  
  
  METHODS
  This was a retrospective study of cases of acute reactions to iopromide and iomeprol reported in two successive time periods. Data from examinations using iopromide (62539 CT scans and 10348 urography scans) and iomeprol (34308 CT scans and 2846 urography scans) were obtained from the computer system of the hospital.
  
  
  RESULTS
  For each period, 154 cases of reactions were reported for iopromide and 86 for iomeprol, being severe in 10 (6.5%) patients for iopromide vs 17 (19.8%) patients for iomeprol; a statistically significant difference of p<0.003 was recorded. The most frequent adverse reactions (%/%) for iopromide/iomeprol were urticaria (29.1/17.2), pruritus (22.6/15.6), upper respiratory tract signs and symptoms (12.1/16.7), oedema (4.3/0), erythemas (3.4/5.0), nausea or vomiting (1.2/11.7) and chest pain (0/3.9) (p<0.0001 for the global comparison). The distribution of the reactions (%/%) by System Organ Class for iopromide/iomeprol was skin (56.7/41.1), respiratory (19.2/26.7), vascular (6.8/2.2), general (5.3/7.2), gastrointestinal (4.6/15.0) and others (7.4/7.9) (p<0.0002 for the global comparison).
  
  
  CONCLUSIONS
  Adverse reactions were more severe for iomeprol. Skin and vascular reactions with no chest pain were more frequent for iopromide, whereas gastrointestinal reactions were more frequent for iomeprol.
  
  
  CONCLUSIONS
  Comparative studies of media contrast safety are scarce and summary information on product characteristics is insufficient. This study showed the differences in severity and profile of adverse reactions between iopromide and iomeprol.
authors.affiliation: Basque Country Pharmacovigilance Unit, Galdakao-Usansolo Hospital, Galdakao, Spain.
authors.forename: M
authors.initials: M
authors.lastname: García
authors.forename: U
authors.initials: U
authors.lastname: Aguirre
authors.forename: A
authors.initials: A
authors.lastname: Martinez
authors.forename: B
authors.initials: B
authors.lastname: Ruiz
authors.forename: U
authors.initials: U
authors.lastname: Lertxundi
authors.forename: C
authors.initials: C
authors.lastname: Aguirre
mesh_terms: D000328:Adult; D002637:Chest Pain / Q000139:chemically induced; D003287:Contrast Media / Q000009:adverse effects*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D007472:Iohexol / Q000009:adverse effects / Q000031:analogs & derivatives*; D007479:Iopamidol / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011537:Pruritus / Q000139:chemically induced; D012140:Respiratory Tract Diseases / Q000139:chemically induced; D012189:Retrospective Studies; D014057:Tomography, X-Ray Computed; D014567:Urography; D014581:Urticaria / Q000139:chemically induced
chemical_list: D003287:Contrast Media; C057937:iomeprol; D007472:Iohexol; C038192:iopromide; D007479:Iopamidol