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http://dx.doi.org/10.24304/kjcp.2021.31.4.324

Signal Detection for Adverse Events of Finasteride Using Korea Adverse Event Reporting System (KAERS) Database  

Baek, Ji-Won (College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University)
Yang, Bo Ram (College of Pharmacy, Chungnam National University)
Choi, Subin (College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University)
Shin, Kwang-Hee (College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University)
Publication Information
Korean Journal of Clinical Pharmacy / v.31, no.4, 2021 , pp. 324-331 More about this Journal
Abstract
To investigate signals of adverse drug reactions of finasteride by using the Korea Adverse Events Reporting System (KAERS) database. This pharmacovigilance was based on the database of the drug-related adverse reactions reported spontaneously to the KAERS from 2013 to 2017. This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of finasteride. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The signals of finasteride were compared with those of the other drugs; dutasteride (similar mechanism of action), minoxidil (different mechanism but similar indications for alopecia), silodosin (different mechanism but similar indications for BPH). It was examined whether the detected signals exist in drug labels in Korea. The total number of adverse event-drug pairs was reported 2,665,429 from 2013 to 2017, of which 1,426 were associated with finasteride. The number of investigated signals of finasteride was 42. The signals that did not include in the drug label were 29 signals, including mouth dry, hypotension, dysuria etc. The signal of finasteride was similar to that of dutasteride and silodosin but was different to that of minoxidil. Early detection of signals through pharmacovigilance is important to patient safety. We investigated 29 signals of finasteride that do not exist in drug labels in Korea. Further pharmacoepidemiological studies should be needed to evaluate the signal causality with finasteride.
Keywords
Finasteride; Korea Adverse Events Reporting System (KAERS); pharmacovigilance; adverse event; safety;
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