{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T03:38:29Z","timestamp":1784864309712,"version":"3.55.0"},"reference-count":27,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2015,7,1]],"date-time":"2015-07-01T00:00:00Z","timestamp":1435708800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2015,7]]},"abstract":"\n Study Objective<\/jats:title>\n \n Finasteride, a 5\u03b1\u2010reductase inhibitor, is marketed in a low dose (1\u00a0mg) as a popular therapy for androgenic alopecia in young men. As case reports and small surveys have suggested a link between persistent sexual dysfunction (\n SD<\/jats:styled-content>\n ) and suicidal ideation (\n SI<\/jats:styled-content>\n ) with low\u2010dose finasteride, the aim of this study was to detect signals of\n SD<\/jats:styled-content>\n and\n SI<\/jats:styled-content>\n secondary to low\u2010dose finasteride use in young men.\n <\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n Retrospective pharmacovigilance disproportionality analysis.<\/jats:p>\n <\/jats:sec>\n \n Data Source<\/jats:title>\n \n United States Food and Drug Administration Adverse Event Reporting System (\n FAERS<\/jats:styled-content>\n ) database.\n <\/jats:p>\n <\/jats:sec>\n \n Measurements and Main Results<\/jats:title>\n \n Low\u2010dose finasteride\u2010related adverse event reports for men aged 18\u201345\u00a0years that were submitted to the\n FAERS<\/jats:styled-content>\n between 1998 and 2013 were retrieved. Multi\u2010item Gamma Poisson Shrinker disproportionality analysis was applied to calculate the empirical Bayes geometric mean (\n EBGM<\/jats:styled-content>\n ) and corresponding 95% confidence interval (\n CI<\/jats:styled-content>\n ) as an association metric between low\u2010dose finasteride and the events of interest. Signals were defined as associations with thresholds of a\n CI<\/jats:styled-content>\n lower limit of 2.0 or greater. Medical Dictionary for Regulatory Activities Preferred Terms denoting to\n SD<\/jats:styled-content>\n and\n SI<\/jats:styled-content>\n were identified to reflect the outcome of interest. In total, of 4910 reports, 577 persistent\n SD<\/jats:styled-content>\n and 39\n SI<\/jats:styled-content>\n adverse event reports (11.8% and 7.9%, respectively) were identified for young men using low\u2010dose finasteride; 34 (87.2%) of the 39 men with\n SI<\/jats:styled-content>\n also experienced\n SD<\/jats:styled-content>\n . The majority of these events were serious (e.g., contributed to the patient's death, hospitalization, or disability). Low\u2010dose finasteride was associated with more than expected reporting of\n SD<\/jats:styled-content>\n in young men compared with reporting of these events with all other drugs within the database (\n EBGM<\/jats:styled-content>\n 28.0, 95%\n CI<\/jats:styled-content>\n 26.1\u201330.0). Disproportional reporting in\n SI<\/jats:styled-content>\n events was noted, although it did not reach signal threshold (\n EBGM<\/jats:styled-content>\n 1.72; 95%\n CI<\/jats:styled-content>\n 1.31\u20132.23). Among serious\n SD<\/jats:styled-content>\n events, 43% led to disability; 28% required medical intervention, including hospitalization; and 5% were life\u2010threatening. Six fatal\n SD<\/jats:styled-content>\n reports were identified.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n Persistent\n SD<\/jats:styled-content>\n might be a potential risk of low\u2010dose finasteride for androgenic alopecia therapy in young men, and this risk might contribute to\n SI<\/jats:styled-content>\n . Our findings provide a strong hypothesis for pharmacoepidemiologic studies to further examine this association.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/phar.1612","type":"journal-article","created":{"date-parts":[[2015,7,1]],"date-time":"2015-07-01T22:48:58Z","timestamp":1435790938000},"page":"687-695","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":85,"title":["Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low\u2010Dose Finasteride: A Pharmacovigilance Study"],"prefix":"10.1002","volume":"35","author":[{"given":"Ayad K.","family":"Ali","sequence":"first","affiliation":[{"name":"Global Patient Safety Eli Lilly and Company Indianapolis Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Balraj S.","family":"Heran","sequence":"additional","affiliation":[{"name":"Department of Family Practice Faculty of Medicine University of British Columbia Vancouver British Columbia Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahyar","family":"Etminan","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Faculty of Medicine Child and Family Research Institute University of British Columbia Vancouver British Columbia Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,7]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"Merck and Co. Inc.Financial results press release. October 27 2014. Available fromhttp:\/\/www.mercknewsroom.com\/news-release\/corporate-news\/merck-announces-third-quarter-2014-financial-results. Accessed December 9 2014."},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1743-6109.2011.02255.x"},{"key":"e_1_2_6_4_1","unstructured":"Food and Drug Administration.Questions and answers: finasteride label changes. Updated April 11 2012. Available fromhttp:\/\/www.fda.gov\/drugs\/drugsafety\/informationbydrugclass\/ucm299754.htm. Accessed December 9 2014."},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.12m07887"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1743-6109.2012.02846.x"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2013.12.014"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/1557988314538445"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2010.12.039"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.7150\/ijms.6048"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S23889"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-199920020-00002"},{"key":"e_1_2_6_13_1","unstructured":"Food and Drug Administration.CFR\u2010Code of Federal Regulations Title 21 Volume 5. Safety Reporting: 21CFR312.32. Updated June 1 2013. Available fromhttp:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=312.32. Accessed December 9 2014."},{"key":"e_1_2_6_14_1","unstructured":"Council for International Organizations of Medical Sciences.Practical aspects of signal detection in pharmacovigilance. Report of CIOMS Working Group VIII. Geneva: CIOMS;2010."},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/0962280211403604"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annepidem.2013.12.009"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000000846"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1001\/archdermatol.2010.256"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.3109\/09546634.2013.813011"},{"key":"e_1_2_6_20_1","unstructured":"Merck and Co. Inc.Propecia (finasteride) product label. Whitehouse Station NJ; January 2014. Available fromhttp:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2014\/020788s024lbl.pdf. 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