Differences in Reproductive Toxicology Between Alopecia Drugs: An Analysis on Adverse Events Among Female and Male Cases

The document from 2016 reported a study that compared the reproductive toxicology of two FDA-approved alopecia drugs, finasteride and minoxidil, using data from the FDA Adverse Event Reporting System (FAERS) from 2004 to 2014. The study found that finasteride was associated with a higher risk of reproductive adverse effects in both female and male cases compared to minoxidil. In males, finasteride was significantly linked to sexual dysfunction, and in females, it was associated with harm to the fetus and uterine disorders. The study also conducted a drug-gene network analysis, which suggested that finasteride could disrupt pathways related to sex hormone signaling and oocyte maturation. The findings indicated that finasteride has a higher liability for reproductive adverse effects, some of which are not currently included in the FDA-approved drug label, and highlighted the need for improved treatment regimens and drug regulation. The study also acknowledged limitations such as incomplete reporting in the FAERS data and called for further research to confirm the findings and fully understand the reproductive toxicity of finasteride.