A Review of the FAERS Data on 5-Alpha Reductase Inhibitors: Implications for Postfinasteride Syndrome
Baas et al., 2018
“FAERS data suggests that finasteride exposure is reported with a diverse collection of symptoms, particularly in younger men on 1 mg dosage compared to older men on 5mg. Many of these complaints fall well out of the realm of previously established AEs from long-term controlled studies.”
FAERS adverse event reports in the period April 2011 to October 2014 were reviewed. Sexual, physical and neurological symptoms were documented.
ADRs were more frequent and significant in younger men. A significant majority of ADRs resulting from use of 1mg Finasteride by younger men were self-reported to the FDA despite a higher reported incidence of disability. Contrastingly, most side effects in older patients were reported by their doctors.
The persistence of symptoms was not able to be assessed from the FAERS snapshot. They note the need for more research, as well as better clinical recording in the form of prior health histories and long term follow up.
