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.

Highlights

  • Alopecia refers to the unwanted loss of hair from the head or body, which affects both men and women [1]

  • Many affected subjects have strong willing to arrest progression of hair loss and stimulate hair growth, motivating basic research and drug development related to alopecia

  • We primarily examined the gender composition of alopecia cases

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Summary

Introduction

Alopecia refers to the unwanted loss of hair from the head or body, which affects both men and women [1]. The predominant impact of alopecia is psychological stress caused by the change in appearance. Many affected subjects have strong willing to arrest progression of hair loss and stimulate hair growth, motivating basic research and drug development related to alopecia. The etiologies of alopecia are still largely unknown, but a series of hypotheses has been proposed to explain the causes [3]. Alopecia areata is considered an autoimmune disease, in which the immune system mistakenly attacks hair follicles [4]. Androgenic alopecia (a.k.a. male pattern baldness) may be a result of hair follicles miniaturization [5, 6] and microinflammation [7]

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