Signal Detection of Alpha-adrenoceptor Antagonist using the KIDS-KAERS database (KIDS-KD)

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.

A Real-World Safety Profile in Neurological, Skin, and Sexual disorders of Antiepileptic Drugs Using Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS)

“…We evaluated the association between AEDs and frequently reported ADRs by estimating reporting odds ratios (RORs), proportional reporting ratios (PRRs), and information components (ICs) based on disproportionality analysis [22]. We considered a signal if the report met all of the following criteria: the number of cases ≥ 3, ROR and PRR ≥ 2, and χ2 ≥ 4, The tower limit of the 95% confidence interval for IC ≥ 0 [23]. All analyses were performed using SAS software, version 9.4 (SAS Institute), or Excel 2019 (Microsoft).…”