Gadopentetate dimeglumine: observations of the clinical research process

Article Abstract:

The Food and Drug Administration (FDA) recently approved the drug gadopentetate dimeglumine for use as a contrast agent. These substances are given to patients undergoing diagnostic imaging to help clarify and define the images produced. Prior to FDA approval, drugs normally undergo extensive testing for their safety and effectiveness. The final phase of testing usually involves a large, randomized double-blind study. In this type of study, patients are given either the new drug or an alternative such as a drug already in use for similar purposes or a placebo, and neither the patient nor the investigator knows who received which drug. This type of testing is difficult to perform when evaluating a drug such as gadopentetate dimeglumine because there are no established drugs for similar use to compare it with and use of a placebo is readily detected on diagnostic images. In the January 1990 issue of Radiology, Goldstein et al. report findings from their study on the safety of gadopentetate dimeglumine. The study reviewed results of clinical trials performed on 1,068 patients, which were was neither double-blinded nor controlled except for a small subset of 88 patients. Overall, 19.9 percent of patients experienced adverse reactions to the drug, a very high rate. However, fewer than 2 percent of the patients experienced severe reactions. Results from the smaller, double-blind, placebo-controlled study give a clearer indication of the safety of this drug. Adverse reactions occurred in 21.7 percent of the patients who received the drug and in 21.4 percent who received the placebo. Reactions reported were similar in both groups and the only patients having severe reactions were in the placebo group. Although this study was small, it does indicate the safety of the drug. The effectiveness of the drug can be tested more readily, even though no alternative drugs are available. Diagnostic images taken before the drug is given for each patient are excellent controls when establishing its effectiveness. Results of studies done so far indicate that gadopentetate dimeglumine greatly enhances diagnostic imaging. Other agents similar to this drug should soon be on the market. It is important that when these drugs are being evaluated for safety and effectiveness, randomized double-blinded studies be performed. (Consumer Summary produced by Reliance Medical Information, Inc.)

editorial, Paramagnetic contrast media

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Increased frequency of reactions to contrast material during gastrointestinal studies

Article Abstract:

Contrast materials are chemicals given to patients undergoing diagnostic examinations to help define or clarify the area of the body being examined. Barium is a commonly used contrast material for examinations of the gastrointestinal (GI) tract. It is generally considered that side effects from barium are extremely rare. Recent reports have indicated that barium may cause adverse reactions more frequently than thought, and two deaths have been attributed to barium usage during colon examinations. Records of patient reactions to contrast materials were reviewed in one hospital for the period between January 1987 and March 1989. A total of 6,918 colon and 11,534 upper GI examinations were performed during the study period. Ten patients experienced 11 reactions to contrast agents given during the course of GI examinations. Seven reactions occurred when barium was given during colon examinations. Glucagon, a hormone sometimes given along with barium, was not used in any of these seven cases. Four reactions occurred when barium was given for upper GI examination. In two of these cases, glucagon had also been given. The lot number of the barium used was different in each case. The results indicated that reactions to contrast materials given during GI examinations is higher than previously reported. Glucagon administered in conjunction with barium did not appear to be the source of the reactions. An additive to the barium suspension is the most likely cause of such reactions. (Consumer Summary produced by Reliance Medical Information, Inc.)

Causes of, Medical examination, Allergy, Barium, Gastrointestinal system, Allergic reaction

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