title: Differences in reproductive toxicology between alopecia drugs: an analysis on adverse events among female and male cases.
abstract: Alopecia is a dermatological condition with limited therapeutic options. Only two drugs, finasteride and minoxidil, are approved by FDA for alopecia treatment. However, little is known about the differences in adverse effects between these two drugs. We examined the clinical reports submitted to the FDA Adverse Event Reporting System (FAERS) from 2004 to 2014. For both female and males, finasteride was found to be more associated with reproductive toxicity as compared to minoxidil. Among male alopecia cases, finasteride was significantly more concurrent with several forms of sexual dysfunction. Among female alopecia cases, finasteride was significantly more concurrent with harm to fetus and disorder of uterus. In addition, drug-gene network analysis indicated that finasteride could profoundly disturb pathways related to sex hormone signaling and oocyte maturation. These findings could provide clues for subsequent toxicological research. Taken together, this analysis suggested that finasteride could be more liable to various reproductive adverse effects. Some of these adverse effects have yet to be warned in FDA-approved drug label. This information can help improve the treatment regimen of alopecia and post-marketing regulation of drug products.
authors.affiliation: Department of Plastic and Reconstruction Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Min
authors.initials: M
authors.lastname: Wu
authors.affiliation: Department of Plastic and Reconstruction Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Qingxiong
authors.initials: Q
authors.lastname: Yu
authors.affiliation: Department of Plastic and Reconstruction Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Qingfeng
authors.initials: Q
authors.lastname: Li
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000009:adverse effects*; D016907:Adverse Drug Reaction Reporting Systems; D000505:Alopecia / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology* / Q000378:metabolism / Q000473:pathology / Q000503:physiopathology; D005260:Female; D005333:Fetus / Q000187:drug effects / Q000378:metabolism / Q000473:pathology; D018120:Finasteride / Q000009:adverse effects*; D005786:Gene Expression Regulation / Q000187:drug effects; D053263:Gene Regulatory Networks / Q000187:drug effects; D006197:Hair / Q000187:drug effects / Q000254:growth & development; D006801:Humans; D008297:Male; D008914:Minoxidil / Q000009:adverse effects*; D012098:Reproduction / Q000187:drug effects*; D018570:Risk Assessment; D012307:Risk Factors; D012737:Sex Factors; D014481:United States; D014486:United States Food and Drug Administration; D014599:Uterus / Q000187:drug effects / Q000378:metabolism / Q000503:physiopathology
chemical_list: D058891:5-alpha Reductase Inhibitors; D018120:Finasteride; D008914:Minoxidil
keywords: FDA adverse event reporting system; Pathology Section; alopecia; finasteride; minoxidil; reproductive toxicity