Korean J Clin Pharm.
2023 Jun;33(2):86-96. 10.24304/kjcp.2023.33.2.86.
Signal Detection of Alpha-adrenoceptor Antagonist using the KIDS-KAERS database (KIDS-KD)
- Affiliations
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- 1College of Pharmacy, Chung-Ang University, Seoul 06974, Republic of Korea
- 2Department of Pharmaceutical Industry, Chung-Ang University, Seoul 06974, Republic of Korea
- 3Department of Global Innovative Drugs, Graduate School of Chung-Ang University, Chung-Ang University, Seoul 06974, Republic of Korea
- KMID: 2544322
- DOI: http://doi.org/10.24304/kjcp.2023.33.2.86
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 alphaadrenoceptor 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.
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