• Title/Summary/Keyword: 의약품부작용보고원시자료

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Comparative Analysis of Death-Related Iodide Contrast Media due to Adverse Reactions of Contrast Media in Computed Tomography (컴퓨터단층촬영의 요오드화 조영제 부작용으로 인한 사망 관련 조영제 비교 분석)

  • Yu, Seong-Min;Han, Dong-Kyoon;Hong, Joo-Wan
    • Journal of radiological science and technology
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    • v.44 no.1
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    • pp.47-52
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    • 2021
  • The incidence of adverse reactions to iodide contrast media was found to have increased owing to their increased use in computed tomography, but the exact reasons were unknown. Based on reported iodide contrast media adverse reactions data, it is recommended to the components of iodide contrast media before use to minimize adverse reactions. It was found that the use of iopromide and iomeprol in iodide contrast media resulted in a higher incidences of death and threat of life resulting from adverse reactions than other ingredients. Patients who are administered iodide contrast media containing iopromide and iomeprol during the computed tomography test should be carefully examined by the relevant medical professional, as the significance of gender and age varies from component to component. As multiple iodide contrast agents are available, the use of an appropriate iodide contrast media will reduce the incidence of iodide contrast media adverse reactions.

Signal Detection of Alpha-adrenoceptor Antagonist using the KIDS-KAERS database (KIDS-KD) (한국 의약품부작용보고원시자료를 활용한 알파차단제의 이상사례 실마리정보 비교 분석)

  • Hyunji Koo;Jun Young Kwon;Jae-Hyuk Choi;Seung Hun You;Sewon Park;Kyeong Hye Jeong;Sun-Young Jung
    • Korean Journal of Clinical Pharmacy
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    • v.33 no.2
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    • pp.86-96
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    • 2023
  • 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.