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Background: We aimed to discuss and compare reported adverse reactions and drug add-ons associated with elobixibat and lubiprostone use in chronic constipation treatment, as the safety of these drugs has not been well examined in post-marketing clinical settings. Research Design and Methods: In this retrospective cohort study, using records of community pharmacies in Japan, we identified new users of elobixibat and lubiprostone. The Japan Pharmaceutical Association sent questionnaires regarding baseline and event data to community pharmacists. The incidence of events and hazard ratio (HR) associated with the study drugs were evaluated. Results: New users of elobixibat (n = 979) and lubiprostone (n = 829) were identified (mean age: 74 and 77 years; females: 59% and 53%, respectively). Although the crude risk ratio of adverse events for elobixibat was 0.79 (95% confidence interval: 0.63-0.99), there was no significant difference in the HR for any of the common events, including drug add-ons (n ≥ 5), compared with those for lubiprostone. Conclusion:No new safety concerns have been raised in relation to elobixibat and lubiprostone use for treating chronic constipation, although the HR of different events varied. Further larger-scale study is needed as the estimates for events of small numbers were unstable ARTICLE HISTORY

Background: To prevent medical accidents, users must be informed of the cautions written in medical package inserts. To realize countermeasures by utilizing information systems, we must also implement a drug information database. However, this is not easy to develop, since the descriptions in package inserts are too complex and their information poorly structured. It is necessary to analyze package insert information and propose a data structure. Methods: We analyzed the descriptions of 'precautions for application' in package inserts via text mining methods. In order to summarize statements, we applied dependency analysis to statements and visualized their relations between predicate words and other words. Furthermore, we extracted words representing timing to execute the order. Results: We found that there are four types of statements: direct orders such as "使用する" (use), causative orders such as "使用させる" (make someone use), direct interdictions such as "使用しない" (do not use), and causative interdictions such as "使用させない" (do not make user use). As for words representing timing, we extracted six groups: "at the time of delivery," "at the time of preparation," "in use," "after use," and "at the time of storage." From these results, we obtained points of consideration concerning the subjects of orders in the statements and timing of their execution. Conclusion: From the obtained knowledge, we can define the information structure used to describe the precautionary statement. It should contain information such as the actions described in the statement, the flag to express an order or interdiction, the subject to be ordered, and the timing.