Prevalence of acute reactions to iopromide: postmarketing surveillance study of 74,717 patients.

BACKGROUND: Iodinated X-ray contrast media (CM) are recognized worldwide to be among the safest and most widely used injectable drugs. However, adverse drug reactions (ADRs) may still occur, ranging in severity from minor disturbances to severe and potentially fatal complications.

PURPOSE: To prospectively determine the incidence and characteristics of acute ADRs during clinical utilization of a single nonionic monomeric contrast agent, iopromide, in routine radiological practice in a large number of nonselected patients.

MATERIAL AND METHODS: 74,717 patients were enrolled in a prospective international postmarketing surveillance registry with iopromide (Ultravist; Bayer Schering Pharma AG, Berlin, Germany). A standardized questionnaire was used to collect the following patient information from 762 centers in 27 countries: baseline demographics, risk factors, premedication regimen, type of examination, route of injection, volume and selected concentration of iopromide, and overall tolerance to CM (utilizing specific criteria and descriptors).

RESULTS: The overall rate of ADRs, including tolerance indicators (TI) (i.e., heat sensation and pain at the injection site), was 2%; when TIs were excluded, the rate was 1.5%. Fourteen serious adverse reactions were reported (rate 0.02%), of which none were fatal. There was a higher incidence of ADRs among women and for the age group ranging between 18 and 30 years. Patients with established risk factors, such as a history of previous CM reaction or allergic diathesis (7.4% and 4.1%, respectively), were at an increased risk for developing an ADR when compared to patients without risk factors (1.2%). The incidence of ADRs was not altered by the use of premedication.

CONCLUSION: The safety of iopromide in routine clinical practice was shown to be comparable to the published safety profiles of other nonionic iodinated contrast agents. Adverse drug reaction rates were affected by age, gender, and risk factors (especially previous CM reactions or allergies), but not by premedication.