Disproportional signal of sexual dysfunction reports associated with finasteride use in young men with androgenetic alopecia: A pharmacovigilance analysis of VigiBase
Nguyen, David-Dan; et al.
Journal of the American Academy of Dermatology (research letter)2022-03
Summary (paraphrased)
A WHO VigiBase case/non-case disproportionality study focused on finasteride and sexual dysfunction in young men treated for hair loss. Building on the same group's JAMA Dermatology work on finasteride and suicidality/depression, it identified about 7,700 sexual-dysfunction reports linked to finasteride and found disproportional reporting concentrated in younger alopecia patients, with the signal markedly stronger than for dutasteride or minoxidil and stronger after 2012. The authors discuss stimulated reporting and nocebo as possible biases while concluding the pattern is unlikely to be fully explained by bias alone, and note the plausibility link between sexual dysfunction and the depression signals seen earlier.
Why it’s in the corpus
The most rigorous global-database evidence on finasteride-associated sexual dysfunction reporting — the WHO-side counterpart to the EMA/EudraVigilance data in LIT-E-001, and the key citation behind regulators' attention to the young alopecia-patient subgroup.
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