Safety and diagnostic image quality of iopromide: Results of a large non-interventional observational study of European and Asian patients (IMAGE)

Acta Radiologica

Volumn 53, Issue 2, 2012, Pages 179-186

  Palkowitsch, Petra ^a   Lengsfeld, Philipp ^a   Stauch, Kathrin ^b   Heinsohn, Christian ^c   Kwon, Soon Tae ^d   Zhang, Shui Xing ^e   Liang, Chang Hong ^e  

^a Global Medical Affairs Diagnostic Imaging   (Germany)

^b Bayer HealthCare   (Germany)

^c Radiological Center   (Germany)

^d Chungnam National University College of Medicine   (South Korea)

^e GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL   (China)

Author keywords

Adverse drug reactions; Antiallergic premedication; Contrast agent; Iopromide; Nonionic

Indexed keywords

ADVERSE DRUG REACTIONS; ANTIALLERGIC PREMEDICATION; CONTRAST AGENT; IOPROMIDE; NONIONIC;

CONTRAST MEDIA; IODINE; IONIZING RADIATION; PHARMACODYNAMICS;

IMAGE QUALITY;

CONTRAST MEDIUM; DIAGNOSTIC AGENT; DRUG DERIVATIVE; IOHEXOL; IOPROMIDE;

ADULT; AGE DISTRIBUTION; AGED; ANGIOGRAPHY; ARTICLE; ASIA; ASIAN; CAUCASIAN; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; DIGITAL SUBTRACTION ANGIOGRAPHY; DRUG TOXICITY; EUROPE; FEMALE; HUMAN; IMAGE ENHANCEMENT; INCIDENCE; MALE; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; PROSPECTIVE STUDY; SEX RATIO; STANDARD; STATISTICS; UROGRAPHY;

ADULT; AGE DISTRIBUTION; AGED; ANGIOGRAPHY; ANGIOGRAPHY, DIGITAL SUBTRACTION; ASIA; ASIAN CONTINENTAL ANCESTRY GROUP; CONTRAST MEDIA; DRUG TOXICITY; EUROPE; EUROPEAN CONTINENTAL ANCESTRY GROUP; FEMALE; HUMANS; IMAGE ENHANCEMENT; INCIDENCE; IOHEXOL; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; SEX DISTRIBUTION; TOMOGRAPHY, X-RAY COMPUTED; UROGRAPHY;

EID: 84858826205     PISSN: 02841851     EISSN: 16000455     Source Type: Journal    
DOI: 10.1258/ar.2011.110359     Document Type: Article

References (27)

1. Bettmann MA, Heeren T, Greenfield A, et al. Adverse events with radiographic contrast agents: results of the SCVIR contrast agent registry. Radiology 1997;203:611-20 (Pubitemid 27227402)
2. Fournier PJ, Steinbrich W, Freitag P, et al. Evaluation of the clinical safety and efficacy of iobitridol (Xenetix) in intravenous urography. Eur J Radiol 1996;23:185-9 (Pubitemid 26426104)
3. Katayama H, Yamaguchi K, Kozuka T, et al. Adverse reactions to ionic and non-ionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media. Radiology 1990;175:621-8 (Pubitemid 20191915)
4. Kopp AF, Mortele KJ, Cho YD, et al. Prevalence of acute reactions to iopromide: postmarketing surveillance study of 74,717 patients. Acta Radiol 2008;49:902-11
5. Lasser EC, Lyon SG, Berry CC. Reports on contrast media reactions: analysis of data from reports to the U.S. Food and Drug Administration. Radiology 1997;203:605-10 (Pubitemid 27227401)
6. Petersein J, Peters CR, Wolf M, et al. Results of the safety and efficacy of iobitridol in more than 61,000 patients. Eur Radiol 2003;13:2006-11 (Pubitemid 36949732)
7. Vogl TJ, Honold E, Wolf M, et al. Safety of iobitridol in the general population and at-risk patients. Eur Radiol 2006;16:1288-97 (Pubitemid 43834714)
8. Palmer FJ. The RACR survey of intravenous contrast media reactions. Final report. Australas Radiol 1988;32:426-8 (Pubitemid 19073587)
9. Spring DB, Bettmann MA, Barkan HE. Nonfatal adverse reactions to iodinated contrast media: spontaneous reporting to the U.S. Food and Drug Administration, 1978-1994. Radiology 1997;204:325-32 (Pubitemid 27337473)
10. MorteléKJ, Oliva MR, Ondategui S, et al. Universal use of nonionic iodinated contrast medium for CT: evaluation of safety in a large urban teaching hospital. Am J Roentgenol 2005;184:31-4 (Pubitemid 40040900)
11. Spring DB, Bettmann MA, Barkan HE. Deaths related to iodinated contrast media reported spontaneously to the U.S. Food and Drug Administration, 1978-1994: effect of the availability of low-osmolality contrast media. Radiology 1997;204:333-7 (Pubitemid 27337474)
12. Morcos SK, Thomsen HS. Adverse reactions to iodinated contrast media. Eur Radiol 2001;11:1267-75 (Pubitemid 32755608)
13. Vandenbroucke JP. What is the best evidence for determining harms of medical treatment? CMAJ 2006;174:645-6 (Pubitemid 43341875)
14. European Commission. Volume 9A of the Rules Governing Medicinal Products in the European Union: Pharmacovigilance for medicinal products for human use. Final September 2008. See http://ec.europa.eu/ health/files/eudralex/vol-9/pdf/ vol9a-09-2008-en.pdf (last checked 22 February 2011)
15. European Federation of Pharmaceutical Industries and Associations. EFPIA code on the promotion of prescription-only medicines to, and interactions with, healthcare professionals. Adopted by EFPIA Board on 05/10/2007. See http://www.efpia.eu/Content/Default. asp?PageID=559&DocID=3483 (last checked 22 February 2011)
16. Goldstein HA, Jacob G, Wiggins JR. New clinical trial experience with iopromide. Invest Radiol 1994;29(Suppl. 2):S208-10 (Pubitemid 24221110)
17. Papanikolaou PN, Christidi GD, Ioannidis JP. Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies. CMAJ 2006;174:635-41 (Pubitemid 43341873)
18. ESUR Guidelines on contrast media. Version 7.0, 2008. See www.esur.org
19. ACR Manual on Contrast Media. Version 7, 2010. See www.acr.org
20. Vandenbroucke JP, Psaty BM. Benefits and risks of drug treatments: how to combine the best evidence on benefits with the best data about adverse effects. JAMA 2008;300:2417-9
21. Lalli AF. Urographic contrast media reactions and anxiety. Radiology 1974;112:267-71
22. Maurer M, Heine O, Wolf M, et al. Safety and tolerability of iobitridol in general and in patients with risk factors: results in more than 160000 patients. Eur J Radiol 2011;80:357-62
23. Spring DB, Winfield AC, Friedland GW, et al. Written informed consent for i.v. contrast-enhanced radiography: patients' attitudes and common limitations. Am J Roentgenol 1988;151:1243-5
24. Thomsen HS. Frequency of acute adverse events to a non-ionic low-osmolar contrast medium: the effect of verbal interview. Pharmacol Toxicol 1997;80:108-10 (Pubitemid 27078235)
25. Weber JCP Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs. In: Rainsford KD, Velo GP, eds. Advances in Inflammation Research. Volume 6. New York, NY: Raven Press, 1984:1-7
26. Hartnell NR, Wilson JP. Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration. Pharmacotherapy 2004;24:743-9 (Pubitemid 38747859)
27. Morcos SK, Thomsen HS, Webb JA. Prevention of generalized reactions to contrast media: a consensus report and guidelines. Eur Radiol 2001;11:1720-8 (Pubitemid 32821379)