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Clinical Observations |
1 Both authors: Division of Drug Risk Evaluation, Food and Drug Administration, HFD-433, White Oak, Building 22, Room 3424, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Received November 18, 2004;
accepted after revision February 7, 2005.
The views expressed are those of the authors and do not necessarily
represent the official position of the U.S. Food and Drug Administration.
Abstract
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CONCLUSION. From 1999 through 2001, deaths attributed to the International Classification of Diseases (ICD) code for contrast media occurred at the rate of 1.1–1.2 per million contrast media packages distributed. An analysis of 1999 death certificates indicated that most deaths attributed to contrast media predictably were associated with renal failure or nephropathy and anaphylaxis or allergic reactions. Risk assessment of the comparative safety of classes or agents was limited by lack of specific contrast media names. Names of administered contrast agents should be recorded in patients' medical records and communicated to primary care physicians and certifiers of death in the event of serious sequelae after an identified recent radiologic procedure.
Keywords: anaphylaxis • contrast media • death certificate • drug reactions • imaging report • mortality • renal failure
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...monomeric ionic x-ray contrast agents that contain amidotrizoic acid, iothalamic acid, or ioxithalamic acid or their salts, alone or in combination, and that were intended for intravascular administration.
The decision was based on
...a reason to suspect that the above mentioned ionic x-ray contrast media, when used as directed, i.e., on intravascular administration, had harmful effects of a severity which is not acceptable.
A later communication said that the decision was mainly based on a number of sources (including clinical and epidemiologic studies, adverse drug reaction reports, and expert reports) that indicated that the intravasal application of ionic media produced a higher risk of adverse drug reactions, including severe reactions, than the nonionic agents.
The German action prompted the staff of the U.S. Food and Drug Administration (FDA) to study the number, rate, and types of deaths attributed to contrast media based on U.S. death certificates and to assess the comparative safety of commonly used diagnostic X-ray contrast agents (Table 1) using death certificate information.
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Distribution data were obtained from the IMS National Sales Perspective database of IMS Health [3], a pharmaceutical marketing research company. The data are based on the estimated number of eaches (defined as individual product packages; a measure appropriate for injectable products) for contrast media distributed to health care facilities in the United States for 1999 through 2001. Included are eaches combined for the Uniform System of Classification categories 40130, "x-ray angiographic–urologic"; 40170, "x-ray myelography"; and 40180, "other contrast media." The health care facilities included in the survey sampling frame are independent pharmacies, chain pharmacies, mass merchandisers with and without pharmacies, mail order pharmacies, food stores with pharmacies, nonfederal hospitals, federal facilities, clinics, long-term care facilities, home health care, health maintenance organizations, and miscellaneous channels (prisons, universities, and so on). The data are projected nationally.
We also collected death certificates for 1999 [4] having any of the following three ICD-10 codes: Y57.5, "adverse effects in therapeutic use of x-ray contrast media"; T88.6, "anaphylactic shock due to adverse effect of correct drug or medicament properly administered"; and T88.7, "unspecified adverse effect of drug or medicament," which includes adverse effect of, allergic reaction to, hypersensitivity to, or idiosyncrasy to a correct drug properly administered. Certificates with these codes were collected through an interagency agreement between the FDA and the Consumer Product Safety Commission and were analyzed. Death certificates with codes T88.6 and T88.7 indicating that contrast medium was the cause of death were grouped for analysis with those for Y57.5.
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A review of 48 U.S. death certificates for 1999 collected from 41 of 52 state and jurisdictional health departments (including New York City and Washington, DC) attributed to contrast media (codes Y57.5, T88.6, and T88.7) indicated that 46 did not contain the name of the contrast agent [4]. Of the two with names, one was ionic and the other was nonionic. Twenty-eight (58%) of the 48 deaths due to contrast agents were associated with renal failure or nephropathy, nine (19%) with anaphylactic shock and allergic reactions, five (10%) with cardiopulmonary arrest, four (8%) with respiratory failure, and two (4%) with stroke or cerebral hypoxia. A majority of deaths was in women (60%) and in whites including Hispanics (94%). The median age at death was 73 years (average, 67 years; range, 16–93 years). Decedents had a variety of contributing conditions mentioned on the death certificates.
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Death certificate data are known to be limited by failure of attribution to the actual cause of death. We do not know how often this occurs in the case of contrast media. Mortality rates are limited by this underattribution and by an unknown annual number of persons administered contrast agents. In this study, the annual number of contrast media packages distributed was used as a surrogate for the number of persons administered these drugs.
Many studies have compared the safety of various contrast agents and classes [5–12]. Epidemiologic and clinical studies have been limited by small sample size; lack of randomization or adjustment for confounding variables; and inability to study the variety of agents, indications, and outcomes. Nonetheless, the low-osmolar nonionic agents have been favored over the high-osmolar ionic ones for their reported lower frequencies of adverse reactions in general and of anaphylactic reactions in particular [5–7, 11, 12]. The relative benefit for renal function of low-osmolar nonionic media compared with high-osmolar ionic media has been controversial [9]. A recent study indicated that the isosmolar nonionic dimeric iodixanol (Visipaque, Nycomed/Amersham) compared with the low-osmolar nonionic monomeric iohexol (Omnipaque, Nycomed/Amersham) was of significant benefit in a group of high-risk patients with diabetes and preexisting abnormal renal function who underwent arteriography [8]. Other studies, some of which have taken into account the higher cost of the low-osmolality agents, have suggested their use in high-risk patients [6, 7, 12] including those with severe cardiac disease, renal dysfunction, previous reaction to a contrast agent, and history of allergy and asthma.
Our collection and review of year 1999 death certificates predictably found that contrast agents were most often associated with deaths due to acute renal failure and anaphylaxis. A majority of deaths occurred in women, in the elderly, and in whites and in those with concurrent medical conditions. We expected to find specific names of contrast media, but they were absent in all but two certificates. This may be the result of radiologists not recording the names of the administered contrast agents in patients' medical records. In the event of serious sequelae after an identified recent radiologic procedure, we suggest that primary care physicians obtain the name of the contrast agent; record it; and, in relevant circumstances, communicate it to certifiers of death.
In summary, our review of death certificates in which contrast agents were attributed as causes of death indicates that X-ray contrast agents in rare instances may cause or contribute to death, especially from renal failure and anaphylactic shock. Assessment of risk by class or individual contrast agent could be improved if the names of specific contrast agents were recorded on death certificates. To enable this, we suggest that the names of administered contrast agents be recorded in patients' medical records and communicated to primary care physicians and certifiers of death in the event of serious sequelae after an identified recent radiologic procedure.
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