Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Signal Detection of Alpha-adrenoceptor Antagonist using the KIDS-KAERS database (KIDS-KD)

한국 의약품부작용보고원시자료를 활용한 알파차단제의 이상사례 실마리정보 비교 분석

  • Hyunji Koo (College of Pharmacy, Chung-Ang University) ;
  • Jun Young Kwon (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Jae-Hyuk Choi (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Seung Hun You (Department of Global Innovative Drugs, Graduate School of Chung-Ang University, Chung-Ang University) ;
  • Sewon Park (Department of Global Innovative Drugs, Graduate School of Chung-Ang University, Chung-Ang University) ;
  • Kyeong Hye Jeong (College of Pharmacy, Chung-Ang University) ;
  • Sun-Young Jung (College of Pharmacy, Chung-Ang University)
  • 구현지 (중앙대학교 약학대학) ;
  • 권준영 (중앙대학교 제약산업학과) ;
  • 최재혁 (중앙대학교 제약산업학과) ;
  • 유승훈 (중앙대학교 대학원 글로벌혁신신약학과) ;
  • 박세원 (중앙대학교 대학원 글로벌혁신신약학과) ;
  • 정경혜 (중앙대학교 약학대학) ;
  • 정선영 (중앙대학교 약학대학)
  • Received : 2023.02.27
  • Accepted : 2023.04.13
  • Published : 2023.06.30
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Abstract

Background: Using KIDS-KAERS database (KIDS-KD) from 2016 to 2020, the aim is to investigate signals of adverse events of alpha-adrenoceptor antagonists and to present adverse events that are not included in the precautions for use when marketing approval. Methods: This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of alpha-adrenoceptor antagonists, such as terazosin, doxazosin, alfuzosin, silodosin, and tamsulosin. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). Detected signals were compared with product labeling and the European Medicines Agency-Important Medical Events list. Results: Out of the total number of 408,077 reports for adverse events, 6,750 cases were reported as adverse events of alpha-adrenoceptor antagonists. Dizziness, mouth dryness, hypotension postural, and oedema peripheral are identified as common adverse events of five alpha-adrenoceptor antagonists and are typically listed on drug labels. However, new signals were detected for pneumonia, chronic obstructive airway disease, eye diseases such as glaucoma and cataracts, fracture, and ileus of tamsulosin that were not previously listed on the drug labels in Korea. Conclusions: This study identified signals related to adverse drug reactions of alpha-adrenoceptor antagonists and presented serious adverse events, suggesting new adverse reactions to be aware of when using alpha-adrenoceptor antagonists.

Keywords

References

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