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For some time the Council on Drugs of the American Medical Association has been interested in the problem of adverse reactions to drugs. In 1954, following the implication of chloramphenicol as a causative agent in the development of blood dyscrasias, the Council established a Registry on Blood Dyscrasias. In 1961 this Registry was renamed the A.M.A. Registry on Adverse Reactions, and its activity was expanded to include all reactions. The Registry received approximately 180 direct reports on reactions to 13 contrast media between Jan. 1, 1963, and July 15, 1967 (Table I). This report will discuss the reactions occurring with administration of only the first five products listed in the table, and it is emphasized that these data are “raw.” Meglumine Diatrizoate (Renografin-60): Renografm-60 was cited in 57 of the direct reports received. A study of the sex and age distribution of patients listed in these reports reveals that reactions occurred in 37 females and 20 males, and that most of the reactions were in patients between the ages of thirty and seventy years (Table II). The largest number of reactions were seen in patients who received between 25 and 50 cc of the drug (Table III). Only 0.1 cc was given 2 of the 8 who received less than 1 cc. More than 50 cc was administered to 3 patients: 140 cc to 1 female and 60 cc and 170 cc, respectively, to 2 males. The meglumine diatrizoate was injected intravenously in 56 of the 57 patients for the following reasons: diagnostic urography (50 cases), arteriography (5 cases), and “undiagnosed polyneuritis” (1 case). The fifty-seventh patient received the material via the urethra for cinecystography. An acute explosive type of reaction developed in all the patients and was characterized by one or more of the following: nausea and vomiting, urticaria, allergic reactions, edema of the face and tongue, erythema, anaphylactic shock, laryngeal edema, motor seizure, cyanosis, vertigo, branchospasm, pulmonary edema, cardiac and respiratory arrest, and oliguria. Three deaths occurred. In the first a 50-year-old female was given an unknown quantity intravenously for arteriography, and shock and coma developed; in the second patient, a 70-year-old male, an intravenous injection of 25 cc for urography was followed by cardiac and respiratory arrest; in the third, a 69-year-old female, cardiac arrest developed after 25 cc was given intravenously for urography. Sodium Diatrizoate (Hypaque): Hypaque was cited in 49 of the direct reports received; reactions occurred in 31 females and 18 males, and most of these patients were over twenty-one years of age. A total of 11 patients received between 1 and 25 cc, while 19 were given between 25 and 50 cc. The sodium diatrizoate was administered intravenously to 47 of the 49 patients (43 for pyelography and 4 for arteriography). It was given once intraspinally for discography and once by T-tube postoperatively for investigation of cholecystitis and cholelithiasis.
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Norman De Nosaquo (1968) studied this question.
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