Death following intravascular administration of contrast media.

Adverse reactions to intravascularly administered contrast media preceding death and the autopsy findings in 44 patients are presented. There is a wide scatter of the age distribution of fatal reactions. The highest incidence is in the 50-70 year age group. Similar observations were obtained from the 405 deaths due to contrast media reported to the Food and Drug Administration of the United States. In the same age group the number of reactions is highest, likewise the autopsy findings. The predominant autopsy findings are pulmonary edema, congestion and hemorrhage; arteriosclerosis, both general and coronary. In the younger age group the autopsy findings are limited mostly to the respiratory tract. Fatal reactions to contrast media occur often without warning and most deaths occur within 15 min to 6 hours. Reactions to contrast media occur without relation to sex or age.

Contrast media adverse reactions: occurrence, recurrence, and distribution patterns.

The second phase of the survey of adverse reactions to contrast media was based on 4,120 case reports and involved the collaboration of radiologists in 45 institutions. It was directed primarily to a study of the distribution patterns of adverse reactions and the likelihood of recurrence of the same reaction on repetition of the examination. It was found that major life-threatening reactions involving the respiratory system are usually accompanied by minor or less serious reactions, while those involving the cardiovascular system are accompanied by the more serious reactions. Major life-threatening reactions do not usually recur on reexamination, while minor reactions tend to be repeated more often.

Adverse reactions to contrast media: a report from the Committee on Safety of Contrast Media of the International Society of Radiology.

More than 300,000 case reports have been collected in a prospective survey of adverse reactions to intravascular contrast media. The reports were provided by radiologists in the United States, Canada, Europe, and Australia and represent the largest survey of its type to date. The overall incidence of reactions was about 5%, lower than any rate reported in the recent literature, and was strikingly similar in all participating countries.

Contrast media in diagnostic radiology: recommendations for labels, package inserts, and dosage determination.

Recommendations are made for updating labels, package inserts, and dosage designation. These are based on the experience of the members of the Committee on Safety of Contrast Media of the International Society of Radiology and their collaborators in a prospective survey on adverse reactions to intravascularly administered contrast media. They are considered to be timely and an answer to a long unfilled need. It is felt that these recommendations reflect not only the opinion and concern of the committee but also that of the radiology community at large. These recommendations are of both medical and medicolegal import. Their application is in the best interests of progressive radiology and good patient care.

Adverse reactions to intravascularly administered contrast media. A comprehensive study based on a prospective survey.

Case reports on 112,003 patients obtained through a prospective survey have been studied and submitted to computer processing. The significant findings have been reviewed and their importance discussedmthe following points are noteworthy: the value of pretesting is doubtful; and routine pretesting is not a recommended procedure. The constant readiness of a fully equipped emergency tray offers far greater security and assurance of patient safety than the unpredictable and unreliable results of pretesting. The over-all incidence of nonfatal reactions is lower than has been prviously indicated: 5.65 per cent for intravenous urography; and 2.33 per cent for intravascular studies. The incidence of fatal reaction (1 in 10,000) is higher than that reported on the basis of retrospective studies. This figure may or may not be duplicated in the next 100,000 examinations. The cause of death in some patients may be related to a combination of factors-primary disease, diagnostic procedure, and contrast medium. The over-all incidence of adverse reactions in patients with allergy is about twice that in the general population. The incidence of adverse reactions is highest in the third and fourth decades, and lowest at either end of the age spectrum. Incidence of reactions is equal in both sexes. History of reaction to previous examinations is not a contraindication to re-examination. The incidence is approximately 3 times that of the general population. Rapid injection rate, in intravenous urography, is accompanied by fewer reactions than a slow injection rate. A slow injection rate in intravenous cholangiography is accompanied by fewer ractions than a rapid injection rate. It is anticipated that this program will continue, so that additional meaningful data and significant information will be accumulated. The members of our Committee are of the firm belief that this program will become the foundation of a permanent national and international adverse reaction reporting system, thus meeting a great need. We invite the collaboration and support of all those interested and involved in the many phases of contrast medium work.