OBJECTIVE

This study aimed to conduct a single-arm, open-label, multicenter postmarketing surveillance study to evaluate the safety of Omniscan immediately and six weeks (± two weeks) after injection.

METHODS

Three sites in India that use Omniscan (gadodiamide; GE Healthcare, Chicago, IL) as a contrast agent were selected. Omniscan is a linear, nonionic, nonprotein-binding gadolinium-based contrast agent. A total of 150 study participants were enrolled for contrast-enhanced magnetic resonance imaging (CE-MRI). All patients were asked for permission to be contacted six weeks (± two weeks) after CE-MRI, and participants were telephonically followed up by a healthcare professional with a questionnaire.

RESULTS

Of the 150 enrolled participants, 133 (89%) completed the telephonic follow-up, scheduled for six weeks (± two weeks) after injection. Of these 133 participants, a total of seven (5.26%) treatment-emergent adverse events (TEAEs) were reported. Out of these seven TEAEs, one TEAE (0.007%) was serious, with seriousness criteria life-threatening. A single event was severe; the remaining adverse events (AEs) were of mild severity. None of the AEs was assessed as related to Omniscan.

CONCLUSIONS

There were no AEs causally related to Omniscan (gadodiamide) immediately after injection and during telephonic follow-up after six weeks (± two weeks). Safety analysis in this postmarketing surveillance did not reveal any increase in the safety risk of Omniscan. No AE persisted for four weeks or more after injection of Omniscan for MRI. CE-MRI with Omniscan was thus generally considered safe and well-tolerated.