Research Papers: Pathology:
Differences in reproductive toxicology between alopecia drugs: an analysis on adverse events among female and male cases
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Min Wu1,*, Qingxiong Yu1,* and Qingfeng Li1
1 Department of Plastic and Reconstruction Surgery, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
* These authors have contributed equally to this work
Qingfeng Li, email:
Keywords: reproductive toxicity; alopecia; finasteride; minoxidil; FDA adverse event reporting system; Pathology Section
Received: August 04, 2016 Accepted: September 29, 2016 Published: October 12, 2016
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.
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