Nonfatal adverse reactions to iodinated contrast media: spontaneous reporting to the U.S. Food and Drug Administration, 1978-1994.

ABSTRACT

PURPOSE: To identify any changes in the frequency of serious, nonfatal adverse drug events (ADEs) reported to the U.S. Food and Drug Administration in 1978-1994 since the introduction of low-osmolality contrast media (LOCM). MATERIALS AND METHODS: Reports of ADEs submitted were reviewed for use of iodinated contrast media. RESULTS: The estimated 170 million contrast medium-enhanced radiologic studies performed in 1978-1994 produced 22,785 reports of mild or moderate ADEs, 2,639 reports of serious but nonfatal ADEs, and 920 reports of death. The most common ADEs (urticaria, dyspnea, vomiting, pruritus, facial edema, and hypotension) ranked similarly for ionic and nonionic contrast media. High-osmolality contrast media were associated with 512 serious, nonfatal ADEs reported in 1978-1986; 1,068 were reported in 1987-1994. Nonionic LOCM were associated with 17 serious, nonfatal ADEs reported in 1978-1986; 609 were reported in 1987-1994. Intrathecal injection of nonionic contrast media was associated with 235 reported serious, nonfatal ADEs; intrathecal ionic [corrected] contrast media were associated with 14 such reported ADEs. CONCLUSION: Reports of serious, nonfatal ADEs are uncommon relative to the use of contrast media. The authors observed no decrease in the number of ADEs reported since the introduction of LOCM but did not consider marketing trends or secular reporting trends.