Post-Finasteride Syndrome (PFS) describes persistent sexual, neurological, and physical adverse reactions in patients who have taken finasteride, a 5-alpha reductase type II enzyme inhibitor used to treat hair loss (under the brand name Propecia or generics) or enlarged prostate (Proscar or generics).
Unfortunately, PFS is a condition with no known cure and few, if any, effective treatments. As an increasing number of men report their persistent side effects to health and regulatory agencies worldwide, medical and scientific communities are only beginning to realize the scope of the problem.
FDA-Mandated Label Changes for Finasteride
- A revision to the Propecia label to include libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.
- A revision to the Proscar label to include decreased libido that continued after discontinuation of the drug.
- A revision to both the Propecia and Proscar labels to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.