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).
Reports of ADEs submitted were reviewed for use of iodinated contrast media.
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 contrast media were associated with 14 such reported ADEs.
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.
Mots-clés Pascal : Produit contraste, Iode, Médicament, Surveillance sanitaire, Toxicité, Symptomatologie, Homme, Epidémiologie, Etats Unis, Amérique du Nord, Amérique, Radiodiagnostic
Mots-clés Pascal anglais : Contrast media, Iodine, Drug, Sanitary surveillance, Toxicity, Symptomatology, Human, Epidemiology, United States, North America, America, Radiodiagnosis
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0416218
Code Inist : 002B02U10. Création : 19/12/1997.