Cognitive dysfunction following finasteride use: a disproportionality analysis of the global pharmacovigilance...

Area of Science:

• Pharmacovigilance
• Neuroscience
• Dermatology

Background:

• Finasteride is a common medication for androgenic alopecia and benign prostatic hyperplasia.
• Growing concerns exist regarding finasteride's safety, with reported cases of cognitive dysfunction.

Purpose of the Study:

• To investigate the potential association between finasteride use and cognitive dysfunction.
• To quantify the risk of cognitive dysfunction in finasteride users.

Main Methods:

• A disproportionality analysis was performed on a large adverse event database (1967-2022).
• Reporting odds ratios (rOR) and 95% confidence intervals were calculated to assess the association.
• Sensitivity analyses were conducted to control for confounding by indication.

Main Results:

• A significant disproportionality was found for cognitive dysfunction associated with finasteride use (rOR 5.43).
• Approximately 2.97% of finasteride adverse events involved cognitive dysfunction, with most cases being serious and without recovery.
• Younger patients (<45 years) and those with alopecia showed a higher reporting odds ratio for cognitive dysfunction.

Conclusions:

• Finasteride use is associated with an increased risk of reporting cognitive dysfunction.
• Younger patients with alopecia appear to be a particularly vulnerable group.
• Prescribers should exercise caution when prescribing finasteride, especially to younger individuals with alopecia.