Cognitive dysfunction following finasteride use: a disproportionality analysis of the global pharmacovigilance database

References

• Kim EH, Larson JA, Andriole GL. Management of benign prostatic hyperplasia. Annu Rev Med. 2016;67(1):137–51. doi: 10.1146/annurev-med-063014-123902
   PubMedGoogle Scholar
• Lolli FPF, Rossi A, Fortuna MC, et al. Androgenetic alopecia: a review. Endocrine. 2017;57:9–17. doi: 10.1007/s12020-017-1280-y
   PubMed Web of Science ®Google Scholar
• Dusková M, Hill M, Hanus M, et al. Finasteride treatment and neuroactive steroid formation. Prague Med Rep. 2009;110(3):222–230.
   PubMedGoogle Scholar
• Kiguradze T, Temps WH, Yarnold PR, et al. Persistent erectile dysfunction in men exposed to the 5a-reductase inhibitors, finasteride, or dutasteride. PeerJ. 2017 Mar 9;5: e3020. DOI:10.7717/peerj.3020.
   PubMed Web of Science ®Google Scholar
• Melcangi RC, Santi D, Spezzano R, et al. Neuroactive steroid levels and psychiatric and andrological features in post-finasteride patients. J Steroid Biochem Mol Biol. 2017 Jul;171:229–35. doi: 10.1016/j.jsbmb.2017.04.003
   PubMed Web of Science ®Google Scholar
• Gray SL, Semla TP. Post-finasteride syndrome. BMJ. Aug 9 2019;366:l5047.10.1136/bmj.l5047.
   PubMedGoogle Scholar
• Motofei IG, Dowland DL, Georgescu SR, et al. Finasteride adverse effects in subjects with androgenic alopecia: a possible therapeutic approach according to the lateralization process of the brain. J DermatolTreat. 2016;27(6):495–7. doi: 10.3109/09546634.2016.1161155
   Google Scholar
• Baas WR, Butcher MJ, Aye L, et al. A Review of the FAERS data on 5-alpha reductase inhibitors: implications for postfinasteride syndrome. Urology. 2018;120:143–9. doi: 10.1016/j.urology.2018.06.022
   PubMed Web of Science ®Google Scholar
• Nguyen DD, Marchese M, Cone EB, et al. Investigation of suicidality and psychological adverse events in patients treated with finasteride. JAMA Dermatol. 2020 Nov 11;157(1):35–42. doi: 10.1001/jamadermatol.2020.3385
   Web of Science ®Google Scholar
• Nguyen DD, Herzog P, Cone EB, et al. Disproportional signal of sexual dysfunction reports associated with finasteride use in young men with androgenetic alopecia: a pharmacovigilance analysis of VigiBase. J Am Acad Dermatol. Mar 26 2022;S0190-9622(22):00527–8. doi: 10.1016/j.jaad.2022.03.037
   Google Scholar
• Welk B, McArthur E, Ordon M, et al. The risk of dementia with the use of 5 alpha reductase inhibitors. J Neurol Sci. 2017;379:109–111. doi: 10.1016/j.jns.2017.05.064
   PubMed Web of Science ®Google Scholar
• Garcia-Argibay M, Hiyoshi A, Fall K, et al. Association of 5α-reductase inhibitors with dementia, depression, and suicide. JAMA Netw Open. 2022;5(12):e2248135. doi: 10.1001/jamanetworkopen.2022.48135
   PubMed Web of Science ®Google Scholar
• Ganzer CA, Jacobs AR, Iqbal F. Persistent Sexual, Emotional, and Cognitive Impairment Post-Finasteride. Am J Mens Health. 2015;9(3):222–228. doi: 10.1177/1557988314538445
   PubMed Web of Science ®Google Scholar
• Li X, Guo Y, Lu Y, et al. Case report: a study of the clinical characteristics and genetic variants of post-finasteride syndrome patients. Transl Androl Urol. 2022;11(10):1452–1457. doi: 10.21037/tau-22-92
   PubMed Web of Science ®Google Scholar
• Vaughan C, Goldstein FC, Tenover JL. Exogenous testosterone alone or with finasteride does not improve measurements of cognition in healthy older men with low serum testosterone. J Androl. 2007;28(6):875–882. doi: 10.2164/jandrol.107.002931
   PubMedGoogle Scholar
• Borst SE, Yarrow JF, Fernandez C, et al. Cognitive effects of testosterone and finasteride administration in older hypogonadal men. Clin Interv Aging. 2014;9:1327–33. doi: 10.2147/CIA.S61760
   PubMed Web of Science ®Google Scholar
• Walf AA, Kaurejo S, Frye CA. Research brief: self-reports of a constellation of Persistent antiandrogenic, estrogenic, physical, and psychological effects of finasteride usage among men. Am J Men’s Health. 2018;12(4):900–906. doi: 10.1177/1557988317750989
   PubMed Web of Science ®Google Scholar
• Norén GN, Orre R, Bate A, et al. Duplicate detection in adverse drug reaction surveillance. Data Mining Knowledge Discovery. 2007;14(3):305–28. doi: 10.1007/s10618-006-0052-8
   Web of Science ®Google Scholar
• CIOMS. Practical Aspects of signal detection in pharmacovigilance [cited 2023 Apr 3]. https://cioms.ch/working_groups/working-group-viii/.
   Google Scholar
• FDA. Guidance for industry: good pharmacovigilance practices and pharmacoepidemiologic assessment [cited 2022 Jun 22]. https://www.fda.gov/media/71546/download.
   Google Scholar
• Trillenberg P, Sprenger A, Machner B. Sensitivity and specificity in signal detection with the reporting odds ratio and the information component. Pharmacoepidemiol Drug Saf. [published online ahead of print, 2023 Mar 26];32(8):910–917. doi: 10.1002/pds.5624
   PubMed Web of Science ®Google Scholar
• Montastruc JL, Sommet A, Bagheri H, et al. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol. 2011;72(6):905–908. doi: 10.1111/j.1365-2125.2011.04037.x
   PubMed Web of Science ®Google Scholar
• Bate A, Evans SJW. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009;18(6):427–436. doi: 10.1002/pds.1742
   PubMed Web of Science ®Google Scholar
• Sendor R, Stürmer T. Core concepts in pharmacoepidemiology: confounding by indication and the role of active comparators. Pharmacoepidemiol Drug Saf. 2022;31(3):261–269. doi: 10.1002/pds.5407
   PubMed Web of Science ®Google Scholar
• Lecce L, Lam YT, Lindsay LA, et al. Aging impairs VEGF-mediated, androgen-dependent regulation of angiogenesis. Mol Endocrinol. 2014 Sep;28(9):1487–501.
   PubMedGoogle Scholar
• Yang CM, Shen YC, Weng SF, et al. Increased risk of dementia in patients with erectile dysfunction: a population-based, propensity score-matched, longitudinal follow-up study. Medicine (Baltimore). 2015;94(24):e990. doi: 10.1097/MD.0000000000000990
   PubMed Web of Science ®Google Scholar
• Häggström S, Tørring N, Møller K, et al. Effects of finasteride on vascular endothelial growth factor. Scand J Urol Nephrol. 2002;36(3):182–187. doi: 10.1080/003655902320131848
   PubMed Web of Science ®Google Scholar
• Moore CS, Grant MD, Zink TA, et al. Erectile dysfunction, vascular risk, and cognitive performance in late middle age. Psychol Aging. 2014;29(1):163–172. doi: 10.1037/a0035463
   PubMed Web of Science ®Google Scholar
• Vandiver R, Lyons MJ, Cuthbert K. Relation between erectile dysfunction and amnestic Mild cognitive impairment across two time Points. Innov Aging. 2019;3(Suppl 1):S958. doi: 10.1093/geroni/igz038.3476
   Google Scholar
• Lindquist LM. VigiBase, the WHO global ICSR database system: basic facts. Drug Inf J. 2008;42(5):409–419. doi: 10.1177/009286150804200501
   Web of Science ®Google Scholar
• Pérez PP-FS. Literature Review. Arch Esp Urol. 2022;75(5):382–99. doi: 10.56434/j.arch.esp.urol.20227505.56
   PubMed Web of Science ®Google Scholar
• Irwig MS. Persistent sexual side effects of finasteride: could they be permanent? J Sex Med. 2012;9(11):2927–2932. doi: 10.1111/j.1743-6109.2012.02846.x
   PubMed Web of Science ®Google Scholar
• Ali AK, Heran BS, Etminan M. Persistent sexual dysfunction and suicidal ideation in young men treated with low-dose finasteride: a pharmacovigilance study. Pharmacotherapy. 2015;35(7):687–695. doi: 10.1002/phar.1612
   PubMed Web of Science ®Google Scholar
• Monnot AD, Fung ES, Compoginis GS, et al. An evaluation of the FDA adverse event reporting system and the potential for reporting bias. J Cosmet Dermatol. 2021;20(6):1849–1854. doi: 10.1111/jocd.14065
   PubMed Web of Science ®Google Scholar
• Uppsala Monitoring Centre. Guideline for using VigiBase data in studies. March, 2021. [cited 2023 Jun 1];15. Available from: https://who-umc.org/media/05kldqpj/guidelineusingvigibaseinstudies.pdf
   Google Scholar
• Pierfitte C, Begaud B, Lagnaoui R, et al. Is reporting rate a good predictor of risks associated with drugs? Br J Clin Pharmacol. 1999;47(3):329–331. doi: 10.1046/j.1365-2125.1999.00881.x
   PubMed Web of Science ®Google Scholar