Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low-Dose Finasteride: A Pharmacovigilance Study
Ali et al., 2015
“significant signals with a 95% CI lower limit of 2.0 or greater continued to exist before and after 2011, irrespective of [persistent sexual dysfunction] public safety knowledge. At the same time, underreporting is likely and might underestimate the actual number of [sexual dysfunction] or [suicidal ideation] events.”
Ali et al. used data mining techniques with FAERS data to conduct a retrospective pharmacovigilance disproportionality analysis. They analysed reports of sexual dysfunction and suicidal ideation between 1998 and 2013 in men aged 18-45 who had used low-dose finasteride.
Supportive of retrospective survey research, the data revealed that a strong signal of persistent sexual dysfunction and disproportional reporting of suicidal ideation. Most sexual dysfunction reports were serious, with 43.5% resulting in disability. 87% of incidences of suicidal ideation occurred in men also experiencing sexual dysfunction from low-dose finasteride. Most of these events were classed as serious (e.g., contributed to the patient’s death, hospitalization, or disability).
Ali note there is mechanistic plausibility in the link between finasteride and the risks of sexual dysfunction and suicidal ideation, and that the disproportionally high reporting could be symptoms of Post-Finasteride Syndrome. The authors conclude that, although a causal link cannot be inferred from this study due to the nature of the data, young men receiving low-dose finasteride for AGA are at risk of persistent sexual dysfunction that may lead to suicidal ideation.
Ali considered the potential for bias due to stimulated reporting of persistent sexual dysfunction. Analysing FAERS adverse event data, Ali et al. acknowledged an increase in ADRs, but noted that significant signals with a 95% confidence interval lower limit of 2.0 or greater exists before and after 2011, irrespective of the public’s knowledge of sexual dysfunction as a safety concern associated with finasteride. Ali et al. considered underreporting likely and the actual incidences of persistent sexual dysfunction to be potentially underestimated.
