Post-marketing surveillance study with iodixanol in 20 185 Chinese patients from routine clinical practices

OBJECTIVE: To determine the incidence of immediate and delayed adverse drug reactions (ADRs), and to assess patient discomfort following administration of iodixanol during imaging examinations in routine clinical practice. METHODS: A total of 20 185 patients across 95 clinical centres were enrolled in a prospective post-marketing surveillance registry with iodixanol. Patients were monitored for occurrence of ADRs immediately following iodixanol administration and for up to 7 days after administration. RESULTS: The overall rate of ADRs was 1.52%, of which 0.58% was immediate and 0.97% was delayed onset. Two patients had non-fatal serious ADRs (0.01%). The ADRs were significantly more common in patients who underwent contrast-enhanced CT/coronary CT angiography vs others (p < 0.001), in those receiving pre-heated iodixanol vs non-heating (p < 0.001), in those aged 70 years or younger (p < 0.001), in those in whom a power injector was used for contrast delivery (p < 0.001) and in those with a history of an allergic reaction to contrast (p = 0.024). Multivariate analysis showed that female gender, intravenous route of contrast injection, body weight ≥80 kg, age less than 65 years, contrast flow rate ≥4 ml s(−1) and prior reaction to iodinated contrast medium were all significant and independent contributors to ADRs. Pre-treatment contrast volume and history of cardiac disease, gout, hypertension, diabetes mellitus or asthma did not affect the rate of ADRs. Discomfort was generally mild, with 94.8% of patients reporting a composite score of 0–3. CONCLUSION: The safety of iodixanol in routine clinical practice was shown to be similar to the published safety profiles of other non-ionic iodinated contrast agents. Patient discomfort during administration was mild or absent in most patients. ADVANCES IN KNOWLEDGE: The major strength of this study is that it included 20 185 patients enrolled in various types of imaging examinations. The safety profile of iodixanol was comparable to previously published work.