Post-marketing Surveillance of Benzbromarone (Urinorm® Tablets) - Incidences of adverse drug reactions and changes in laboratory values relating to safety and efficacy under routine drug usage -

DOI 13 References
  • Oikawa Toshihiro
    Torii Pharmaceutical Co.,Ltd. Department of Pharmacovigilance
  • Goto Yuji
    Torii Pharmaceutical Co.,Ltd. Department of Pharmacovigilance
  • Sato Keiji
    Torii Pharmaceutical Co.,Ltd. Department of Pharmacovigilance
  • Kojima Tomoo
    Torii Pharmaceutical Co.,Ltd. Department of Pharmacovigilance
  • Ashizawa Hiroshi
    Torii Pharmaceutical Co.,Ltd. Department of Pharmacovigilance

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  • ベンズブロマロン（ユリノーム®錠）の製造販売後調査　ー使用実態下における副作用発現状況ならびに安全性および有効性に関連する臨床検査値の推移ー
  • Post-marketing Surveillance of Benzbromarone (Urinorm® Tablets) - Incidences of adverse drug reactions and changes in laboratory values relating to safety and efficacy under routine drug usage -

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A prospective, drug use-results survey was conducted to reexamine the safety and efficacy of benzbromarone (Urinorm® Tablets) under routine drug usage. In 133 of 4,659 patients analyzed for safety, there were 144 adverse drug reactions, indicuting that the proportion of patients with adverse drug reactions was 2.43%. The most common adverse drug reactions were abnormal findings on laboratory examination (48 patients, 62 events), including abnormal liver function tests (40 patients, 51 events), such as increased AST and increased ALT. In addition, hepatobiliary disorders (21 patients, 21 events), such as liver disorder ; skin and subcutaneous tissue disorders (18 patients,21 events), such as rash ; and gastrointestinal disorders (12 patients,13 events), such as diarrhea, were noted. Analysis of adverse drug reactions stratified by patient characteristics did not show any specific factors that affected the incidence of adverse drug reactions. ALT, serum creatinine, and eGFR did not change substantially after the administration of benzbromarone. After the administration of benzbromarone, the serum uric acid level decreased in a dose-dependent manner. In patients with a baseline eGFR of 30mL/min/1.73m2 or more, the serum uric acid level was maintained at 6mg/dL or less (therapeutic target) after the administration of benzbromarone.

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