Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Signal Detection for Adverse Events of Finasteride Using Korea Adverse Event Reporting System (KAERS) Database

의약품이상사례보고시스템 데이터베이스를 이용한 피나스테리드의 약물유해반응 실마리 정보 탐색

  • 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)
  • 백지원 (경북대학교 약학대학, 약학연구소) ;
  • 양보람 (충남대학교 약학대학) ;
  • 최수빈 (경북대학교 약학대학, 약학연구소) ;
  • 신광희 (경북대학교 약학대학, 약학연구소)
  • Received : 2021.09.15
  • Accepted : 2021.12.19
  • Published : 2021.12.31
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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

Acknowledgement

본 연구는 한국연구재단 이공학개인기초기본연구 지원 사업의 지원을 수행되었다(NRF-2018R1D1A1B07050267). 본 논문은 교육부 및 한국연구재단의 4단계 두뇌한국21 사업(4단계 BK21 사업)으로 지원된 연구이다(5199990614732).

References

  1. Steers WD. 5alpha-reductase activity in the prostate. Urology 2001;58(6 Suppl 1):17-24. https://doi.org/10.1016/S0090-4295(01)01299-7
  2. Nguyen DD, Marchese M, Cone EB, et al. Investigation of suicidality and psychological adverse events in patients treated with finasteride. JAMA Dermatol 2021;157(1):35-42. https://doi.org/10.1001/jamadermatol.2020.3385
  3. World Health Organization (WHO). VigiAccessTM. Available from http://www.vigiaccess.org. Accessed August 31, 2021.
  4. Sica DA. Minoxidil: an underused vasodilator for resistant or severe hypertension. J Clin Hypertens (Greenwich) 2004;6(5):283-7. https://doi.org/10.1111/j.1524-6175.2004.03585.x
  5. Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol 2004;150(2):186-94. https://doi.org/10.1111/j.1365-2133.2004.05785.x
  6. Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha(1A)-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol 2013;189(1 Suppl):S122-8.
  7. Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidem Drug Saf 2001;10(6):483-6. https://doi.org/10.1002/pds.677
  8. Egberts AC, Meyboom RH, van Puijenbroek EP. Use of measures of disproportionality in pharmacovigilance: three Dutch examples. Drug Saf 2002;25(6):453-8. https://doi.org/10.2165/00002018-200225060-00010
  9. Lindquist M, Stahl M, Bate A, Edwards IR, Meyboom RH. A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international database. Drug Saf 2000;23(6):533-42. https://doi.org/10.2165/00002018-200023060-00004
  10. Kim M-S, You S-H, Park HM, et al. Patterns of spontaneous adverse events reporting on human papillomavirus vaccines according to the applicability of Brighton Collaboration Criteria in Korea from 2008 to 2017. Korean J Clin Pharm 2020;30(1):19-30. https://doi.org/10.24304/kjcp.2020.30.1.19
  11. Baig MS, Kolasa-Wolosiuk A, Pilutin A, et al. Finasteride-induced inhibition of 5alpha-reductase type 2 could lead to kidney damage-animal, experimental study. Int J Environ Res Public Health 2019;16(10):1726. https://doi.org/10.3390/ijerph16101726
  12. Traish AM. Health risks associated with long-term finasteride and dutasteride use: it's time to sound the alarm. World J Mens Health 2020;38(3):323-37. https://doi.org/10.5534/wjmh.200012
  13. Irwig MS. Depressive symptoms and suicidal thoughts among former users of finasteride with persistent sexual side effects. J Clin Psychiatry 2012;73(9):1220-3. https://doi.org/10.4088/JCP.12m07887
  14. Melcangi RC, Caruso D, Abbiati F, et al. Neuroactive steroid levels are modified in cerebrospinal fluid and plasma of post-finasteride patients showing persistent sexual side effects and anxious/depressive symptomatology. J Sex Med 2013;10(10):2598-603. https://doi.org/10.1111/jsm.12269