Incidence of roentgen contrast medium reactions after intravenous injection in pre-registration trials and post-marketing surveillances.
The relative risk of adverse drug reactions of ionic versus non-ionic contrast media injected i.v. were compared for different types of trials using odds-ratio. The absolute and relative risk found in large post-marketing trials were compared with that found in the iohexol pre-registration trials. The absolute risks were 2 to 10 times higher in the pre-registration trials compared to the post-marketing surveillances. The relative risk for all adverse drug reactions was 3 to 6 times higher for ionic vs. non-ionic media and independent of pre- or post-registration studies. The odds-ratio seems to be a feasible method of comparing the relative risk of adverse reactions in various trials.
Andrew
E
E
Clinical Research and Development, Nycomed as, Oslo, Norway.
Haider
T
T
D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry; D004341:Drug Evaluation; D006801:Humans; D007275:Injections, Intravenous; D007472:Iohexol / Q000009:adverse effects; D009994:Osmolar Concentration; D011358:Product Surveillance, Postmarketing
D003287:Contrast Media; D007472:Iohexol