{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T21:49:24Z","timestamp":1784065764953,"version":"3.55.0"},"reference-count":34,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,12,8]],"date-time":"2024-12-08T00:00:00Z","timestamp":1733616000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:p>Drug labels summarize essential safety information for healthcare professionals and patients. However, studies have reported a discordance of safety information in drug labeling among countries\/regions. We aimed to identify the characteristics of adverse events associated with discordant safety warnings during the initial labeling of new drugs approved at approximately the same time in Japan, the United States, and the European Union. Safety warning discordance\/concordance between two countries\/regions and the explanatory variables were assessed using multivariable logistic regression. The safety warning concordance rate was 71.0% (152\/214) for the United States and the European Union, 59.5% (135\/227) for Japan and the United States, and 64.3% (144\/224) for Japan and the European Union. A significant association with discordant safety warnings was revealed for \u201cadverse event rate\u201d and \u201cwarning status in a similar drug\u201d between the United States and the European Union; \u201cadverse event rate,\u201d \u201cadverse event included in important medical event list,\u201d and \u201cwarning status in a similar drug\u201d between Japan and the United States; and \u201cadverse event included in important medical event list\u201d and \u201cwarning status in a similar drug\u201d between Japan and the European Union. Clarifying and publicizing the reasons for safety warnings, along with an awareness of the factors associated with the discordance identified in this study, will help healthcare professionals, patients, marketing authorization holders, and regulatory authorities around the world share the background of country\/region\u2010specific warnings, reducing the possibility of confusion among them due to the discrepancies.<\/jats:p>","DOI":"10.1002\/cpt.3518","type":"journal-article","created":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T06:59:23Z","timestamp":1733727563000},"page":"779-786","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Background Factors Contributing to Safety Warning Discordance in the Initial Labeling of New Drugs in Japan, the United States, and the European Union"],"prefix":"10.1002","volume":"117","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5044-8880","authenticated-orcid":false,"given":"Koichi","family":"Fukuda","sequence":"first","affiliation":[{"name":"Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences Kitasato University  Minato\u2010ku Japan"},{"name":"Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency  Chiyoda\u2010ku Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0600-9412","authenticated-orcid":false,"given":"Mamoru","family":"Narukawa","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences Kitasato University  Minato\u2010ku Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,12,8]]},"reference":[{"key":"e_1_2_12_1_1","unstructured":"U.S. Food and Drug Administration.Think it through: managing the benefits and risks of medicines. <https:\/\/www.fda.gov\/drugs\/information\u2010consumers\u2010and\u2010patients\u2010drugs\/think\u2010it\u2010through\u2010managing\u2010benefits\u2010and\u2010risks\u2010medicines> (2018). 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