The US Food and Drug Administration (FDA) has issued a new warning about finasteride, a drug commonly prescribed for androgenic alopecia.
The agency highlighted potential risks of serious, long-term side effects, including persistent sexual dysfunction and psychological harm. The updated warning follows a surge in reported cases of post-finasteride syndrome (PFS), with patients alledging symptoms such as erectile dysfunction, genital pain, altered libido and mood disturbances – including anxiety and depression. In severe cases, suicidality has been reported.
One such case, currently circulating in the media, involves 28-year-old Sawyer Hart, who began using a finasteride-based topical gel after receiving a prescription through a telehealth platform. He reported developing erectile issues, testicular pain and panic attacks shortly after initiating treatment. The agency has not approved any topical finasteride formulations and has issued a public warning about compounded versions of the popular hair loss drug sold via telehealth platforms.
The FDA now acknowledges a “potentially serious risk” to the genitourinary system from finasteride, particularly when adverse effects persist after discontinuation. The agency has updated drug safety communications and is reviewing the cumulative post-marketing safety data.
