Analysis of Adverse Events Associated with Low-dose Estrogen-Progestin Based on Data from the Japanese Adverse Drug Event Report Database and the Relief System for Sufferers from Adverse Drug Reactions

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  • Ariyama Tomohiro
    Department of Practical Pharmacy, Faculty of Pharmaceutical Science, Toho University
  • Sato Moegi
    Department of Practical Pharmacy, Faculty of Pharmaceutical Science, Toho University
  • Tanaka Hiroyuki
    Department of Practical Pharmacy, Faculty of Pharmaceutical Science, Toho University
  • Ishii Toshihiro
    Department of Practical Pharmacy, Faculty of Pharmaceutical Science, Toho University

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  • 我が国における低用量エストロゲン・プロゲスチン製剤による有害事象報告と医薬品副作用被害救済制度給付決定情報の調査解析

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<p>Low-dose estrogen-progestin (LEP) has been shown to reduce the severity of dysmenorrhea symptoms. Its use has been approved for dysmenorrhea management in Japan. The majority of patients undergoing LEP treatment are young. Therefore, side effect management is extremely important. We aimed to determine the status of actual adverse reactions to LEP using national public databases.</p><p>Data from the Japanese Adverse Drug Event Report (JADER: April 2004-September 2016) database and the Information on the Decision on Payment/non-payment of Adverse Reaction Relief Benefits (April 2004-September 2016) were downloaded from the website of the Pharmaceuticals and Medical Devices Agency.</p><p>The number of reports on LEP-related adverse events in the JADER was 1,449 (920 cases [63.5％] of thromboembolism, 85 cases [5.9％] of bleeding, 48 cases [3.2％] of liver function disorder, and 43 cases [3.0％] of malignant tumors). The reporting odds ratio (95％ confidence interval) of LEP associated with thromboembolism was 52.9 (46.7-59.8). The incidence of thromboembolic events increased with an increase in age. The proportion of severe cases did not differ between individuals aged 30 years and those aged ≧40 years. Thromboembolism occurred within 90 days in many cases. There were 136 requests for the involvement of the relief system, among which 125 (91.9％) received payment.</p><p>This study clarified the occurrence of LEP-related adverse events and relief system usage. As the number of adverse events reported exceeded the number of relief systems available, it is conceivable that this system is not completely utilized.</p>

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