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.

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.