A POST-MARKETING SURVEILLANCE OF SULPREPⓇ IN PATIENTS UNDERGOING COLONOSCOPY
2026 Volume 68 Issue 4 Pages 352-361
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2026 Volume 68 Issue 4 Pages 352-361
Background and Aims: SULPREPⓇ, a bowel preparation agent for colonoscopy, became commercially available in Japan in 2021. This post-marketing surveillance investigated the safety and effectiveness of SULPREPⓇ in Japanese clinical practice.
Methods: This study enrolled patients who used SULPREPⓇ for bowel preparation before undergoing colonoscopy between November 2021 and November 2022. The number of adverse drug reactions and the proportion of patients in whom SULPREPⓇ was effective were calculated separately for the one- and two-day split-dose regimens.
Results: Adverse drug reactions were reported in 10 patients. Of these, two cases of hypermagnesemia, one case of ischemic colitis, and one case of renal dysfunction were observed. However, none of the adverse reactions were serious. The effectiveness rate was 97.6% (1,030/1,055 patients), with no significant difference between the one- and two-day split-dose regimens.
Conclusions: No new safety concerns arose with the use of SULPREPⓇ for bowel preparation before colonoscopy in Japanese clinical practice. Sufficient effectiveness rates were observed with both the one- and two-day split-dose regimens.
