Intravenous contrast media in uroradiology: evaluation of safety and tolerability in almost 50,000 patients.
OBJECTIVE
To evaluate the frequency of adverse events and possible risk factors after the administration of an intravenous contrast medium (CM), iobitridol, in a large multicentre postmarketing surveillance study.


METHODS
A total of 49,975 patients undergoing intravenous urography were included in this study. A water-soluble, non-ionic CM (iobitridol, 1 ml/kg body weight) was administered. Age, sex, indication for the actual examination and adverse events were documented. Also, high-risk patients were identified.


RESULTS
Of the 49,975 patients, 28,336 (56.7%) were males and 21,639 (43.3%) females. Indications for urography were mainly urolithiasis (39.1%), inflammatory diseases (25.6%) and tumours (13.9%). Additionally, 7.4% were risk patients: 1.9% with creatinine >1.5 mg/dl (0.1% were on haemodialysis); 0.8% had a history of previous allergic reactions to CM, 3.7% pre-existing asthma or allergies and 2% other risk factors against CM examination. Only 0.9% of the patients experienced acute adverse events that were non-serious and transient. Less than 0.1% of the patients experienced vomiting, dizziness or cardiovascular problems. Only 1 patient developed an anaphylactic shock but recovered fully under treatment. A chi(2) analysis revealed that adverse reactions occurred in patients with pre-existing renal insufficiency or allergies. Significantly more females had contrast-agent-related symptoms compared to men. Patients undergoing urography for urolithiasis had significantly fewer symptoms compared to patients with other indications.


CONCLUSIONS
Iobitridol is clinically safe and well tolerated in urography as demonstrated in this study of a large patient population, producing mainly minor symptoms as adverse events. However, caution is advised when administering iobitridol to high-risk patients.
Wendt-Nordahl
Gunnar
G
Department of Urology, University Hospital Mannheim, Mannheim, Germany.
Rotert
Harald
H
Trojan
Lutz
L
Michel
Maurice Stephan
MS
Peters
Candida R
CR
Alken
Peter
P
Knoll
Thomas
T
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects*; D004342:Drug Hypersensitivity / Q000453:epidemiology / Q000209:etiology*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007275:Injections, Intravenous; D007472:Iohexol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012307:Risk Factors; D012449:Safety; D014567:Urography
D003287:Contrast Media; C093233:iobitridol; D007472:Iohexol