Document Detail

Reports on contrast media reactions: analysis of data from reports to the U.S. Food and Drug Administration.
MedLine Citation:
PMID:  9169676     Owner:  NLM     Status:  MEDLINE    
PURPOSE: To compare U.S. Food and Drug Administration (FDA) and manufacturer data about patient reactions to ionic and nonionic, low- and high-osmolar contrast media from 1990 through 1994. MATERIALS AND METHODS: Reactions to all available high-osmolar and four low-osmolar contrast media (ioxaglate, iohexol, iopamidol, and ioversol) were compared. Ioxaglate is composed of charged particles, and data are reported separately. Reactions were also compared with data from 1980 to 1984, when only high-osmolar contrast media were available. RESULTS: With high-osmolar contrast media compared with the three noncharged low-osmolar media, the incidence (per million examinations) was highest for all reported reactions (193.8 vs 44.4), severe reactions (37.4 vs 10.5), and deaths (3.9 vs 2.1). With high-osmolar media compared with ioxaglate, respectively, the incidence of total reactions was higher (193.8 vs 142.5), of severe reactions was almost the same (37.4 vs 33.6), and of death was lower (3.9 vs 6.4). The incidence of severe reactions to total reactions was higher with nonionic media (23.7%) and ioxaglate (23.6%) than with ionic media (19.3%). The incidence of death to severe reactions was 19.7% with nonionic media, 19.0% with ioxaglate, and 10.4% with high-osmolar media. The incidence of renal failure (as a percentage of total reports) was approximately 3.6 times higher with all low-osmolar contrast media (2.3%) than with high-osmolar media (0.6%), usually in patients with pathologic cardiac conditions. CONCLUSION: All of these factors merit consideration in the evaluation of the utility of a given contrast medium.
E C Lasser; S G Lyon; C C Berry
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Radiology     Volume:  203     ISSN:  0033-8419     ISO Abbreviation:  Radiology     Publication Date:  1997 Jun 
Date Detail:
Created Date:  1997-06-24     Completed Date:  1997-06-24     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0401260     Medline TA:  Radiology     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  605-10     Citation Subset:  AIM; IM    
Department of Radiology, University of California, San Diego, La Jolla 92093-0632, USA.
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MeSH Terms
Adverse Drug Reaction Reporting Systems* / statistics & numerical data
Aged, 80 and over
Cause of Death
Contrast Media / adverse effects*,  chemistry,  classification
Drug Monitoring / statistics & numerical data
Heart Diseases / complications
Iohexol / adverse effects,  chemistry
Iopamidol / adverse effects,  chemistry
Ioxaglic Acid / adverse effects,  chemistry
Kidney Failure / chemically induced
Middle Aged
Osmolar Concentration
Triiodobenzoic Acids / adverse effects,  chemistry
United States / epidemiology
United States Food and Drug Administration*
Reg. No./Substance:
0/Contrast Media; 0/Ions; 0/Triiodobenzoic Acids; 59017-64-0/Ioxaglic Acid; 62883-00-5/Iopamidol; 66108-95-0/Iohexol; 87771-40-2/ioversol
Comment In:
Radiology. 1998 Jun;207(3):832-3   [PMID:  9609917 ]
Erratum In:
Radiology 1997 Sep;204(3):876

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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