日本の有害事象自発報告データベース(JADER)を用いたスイッチOTC化した抗アレルギー薬の有害事象に関する解析

書誌事項

タイトル別名
  • Analysis of Adverse Events Associated with the Anti-Allergic Agents Rx-to-OTC-Switched Using Data Mining of the Japanese Adverse Drug Event Report (JADER) Database

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説明

<p>With the escalation of pollinosis prevalence and promotion of self-medication, the importance of the anti-allergic Rxto-OTC-switched agents has been increasing. Moreover, the law amendment on related proprietary drugs lifted the ban on selling these drugs over the Internet, making them more easily accessible by ordinary citizens. Because of this, safety assurance about drug information supplementary materials from pharmacists is desired. Therefore, we assessed safety signals by detecting adverse events caused by anti-allergic Rx-to-OTC-switched agents.</p><p>We analyzed data from the Japanese Adverse Drug Event Report for April 2004 to September 2013. We surveyed 10 types of adverse events, including hepatic disorders, severe cutaneous adverse reactions, and anaphylactic reactions. We used the reported odds ratio as the safety index.</p><p>Signals were detected in hepatic disorders with all medicines, except for emedastine and diphenhydramine. In addition, signals were detected in hepatic disorders with all of the anti-allergic Rx-to-OTC-switched agents, independent of sex and age range. The results of this study suggest that people who purchase anti-allergic Rx-to-OTC-switched agents should be alerted to the associated adverse events. Moreover, the results showed that using anti-allergic Rx-toOTC-switched agents potentially leads to severe adverse events, indicating that it is essential to provide drug information regardless of risk classification for the proper use of the drugs.</p>

収録刊行物

  • 医療薬学

    医療薬学 41 (9), 667-675, 2015

    一般社団法人日本医療薬学会

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