REPORTS ON CONTRAST-MEDIA REACTIONS - ANALYSIS OF DATA FROM REPORTS TO THE US FOOD-AND-DRUG-ADMINISTRATION

PURPOSE: To compare U.S. Food and Drug Administration (FDA) and manufa cturer data about patient reactions to ionic and nonionic, low- and hi gh-osmolar contrast media from 1990 through 1944. MATERIALS AND METHOD S: Reactions to all available high-osmolar and four low-osmolar contra st media (ioxaglate, iohexol, iopamidol, and ioversol) were compared. Ioxaglate is composed of charged particles, and data are reported sepa rately. Reactions were also compared with data from 1980 to 1984, when only high-osmolar contrast media were available. RESULTS: With high-o smolar contrast media compared with the three noncharged low-osmolar m edia, the incidence (per million examinations) was highest for all rep orted 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 14 2.5), of severe reactions was almost the same (37.4 vs 33.6), and of d eath was lower (3.9 vs 6.4). The incidence of severe reactions to tota l reactions was higher with nonionic media (23.7%) and ioxaglate (23.6 %) than with ionic media (19.3%). The incidence of death to severe rea ctions was 19.7% with nonionic media, 19.0% with ioxaglate, and 10.4% with high-osmolar media. The incidence of renal failure (as a percenta ge of total reports) was approximately 3.6 times higher with all low-o smolar contrast media (2.3%) than with high-osmolar media (0.6%), usua lly in patients with pathologic cardiac conditions. CONCLUSION: All of these factors merit consideration in the evaluation of the utility of a given contrast medium.