J Korean Med Sci.  2013 Dec;28(12):1703-1710. 10.3346/jkms.2013.28.12.1703.

Comparison of the Safety of Seven Iodinated Contrast Media

Affiliations
  • 1Office of Drug Safety Information II, Korea Institute of Drug Safety & Risk Management, Seoul, Korea. bjpark@snu.ac.kr
  • 2Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
  • 3Medical Research Collaborating Center, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
  • 4Medical Research Center, Seoul National University, Seoul, Korea.
  • 5Department of Occupational and Environmental Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University, School of Medicine, Seoul, Korea.
  • 6Department of Family Medicine, Seoul National University Bundang Hospital, Seoul, Korea.

Abstract

We aimed to determine the characteristic adverse events (AEs) of iodinated contrast media (IOCM) and to compare the safety profiles of different IOCM. This study used the database of AEs reports submitted by healthcare professionals from 15 Regional Pharmacovigilance Centers between June 24, 2009 and December 31, 2010 in Korea. All reports of IOCM, including iopromide, iohexol, iopamidol, iomeprol, ioversol, iobitridol and iodixanol, were analyzed. Safety profiles were compared between different IOCM at the system organ level using the proportional reporting ratio (PRR) and 95% confidence interval (95% CI). Among a total of 48,261 reports, 6,524 (13.5%) reports were related to the use of IOCM. Iopromide (45.5%), iohexol (16.9%), iopamidol (14.3%) and iomeprol (10.3%) were identified as frequently reported media. 'Platelet, bleeding & clotting disorders' (PRR, 29.6; 95%CI, 1.9-472.6) and 'urinary system disorders' (PRR, 22.3; 95% CI, 17.1-29.1) were more frequently reported for iodixanol than the other IOCM. In conclusion, the frequency of AEs by organ class was significantly different between individual media. These differences among different IOCM should be considered when selecting a medium among various IOCM and when monitoring patients during and after its use to ensure optimum usage and patient safety.

Keyword

Contrast Media; Adverse Drug Reaction Reporting Systems; Patient Safety

MeSH Terms

Adolescent
Adult
Aged
Aged, 80 and over
Blood Platelet Disorders/chemically induced
Child
Child, Preschool
Contrast Media/*adverse effects/diagnostic use
Databases, Factual
Female
Humans
Infant
Infant, Newborn
Iodine Radioisotopes/chemistry
Male
Middle Aged
Neoplasms/radionuclide imaging
Radiopharmaceuticals/*adverse effects/diagnostic use
Urologic Diseases/chemically induced
Young Adult
Contrast Media
Iodine Radioisotopes
Radiopharmaceuticals

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