Document Detail


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.
MedLine Citation:
PMID:  9240516     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: To determine whether reports of iodinated contrast medium-related deaths have decreased since low-osmolality contrast media (LOCM) became widely available in the United States. MATERIALS AND METHODS: With use of reports to the U.S. Food and Drug Administration Spontaneous Reporting System, data on iodinated contrast medium-related deaths after LOCM became available (1987-1994) were compared with data on deaths in the period before (1978-1986) and with data on deaths in an even earlier period (1967-1977). RESULTS: In 1967-1994, more than 1,000 contrast medium-related deaths were reported, 850 occurring during 1978-1994. Excluding 22 myelography-related deaths, 37% [corrected] more deaths were reported each year in 1987-1994 than in 1978-1986. Most of this increase was associated with the use of nonionic contrast media. In 1966-1977, 228 deaths were reported; in 1978-1986, 376; and in 1987-1994, 474. In 1987-1994, 220 deaths were associated with use of high-osmolality contrast media alone, 32 with ionic LOCM alone, 214 with nonionic LOCM alone, and eight with combinations of contrast media. CONCLUSION: Despite the availability of LOCM in the United States, data for 1978-1994 do not show a marked decrease in contrast medium-related deaths. Since 1990, more deaths have been associated with LOCM than with conventional contrast media. Although these data have substantial limitations, they shed some light on contrast medium use and safety.
Authors:
D B Spring; M A Bettmann; H E Barkan
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Radiology     Volume:  204     ISSN:  0033-8419     ISO Abbreviation:  Radiology     Publication Date:  1997 Aug 
Date Detail:
Created Date:  1997-08-19     Completed Date:  1997-08-19     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0401260     Medline TA:  Radiology     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  333-7     Citation Subset:  AIM; IM    
Affiliation:
Department of Diagnostic Imaging, Kaiser Permanente Medical Center, Oakland, CA 94611-5693, USA.
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MeSH Terms
Descriptor/Qualifier:
Adverse Drug Reaction Reporting Systems / statistics & numerical data*
Contrast Media / adverse effects*,  chemistry
Female
Humans
Male
Mortality / trends
Osmolar Concentration
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/Contrast Media
Comments/Corrections
Comment In:
Radiology. 1998 Feb;206(2):560-1   [PMID:  9457213 ]
Erratum In:
Radiology 1998 Feb;206(2):565

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


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