Health Risks and Lack of Approval
The FDA issued a warning about the topical spray version of finasteride, highlighting that it is not FDA-approved and has been linked to adverse events such as erectile dysfunction, anxiety, and suicidal ideation.
Compounded topical finasteride products lack FDA-approved labeling, and the FDA has received 32 reports of serious side effects potentially putting consumers at risk.
Telehealth and Regulatory Concerns
Telehealth companies like Hims and Keeps sell these sprays through compounding pharmacies, bypassing the need for FDA approval but raising concerns over advertising standards and patient safety.
Despite legal sales, there's criticism that telehealth providers may prioritize prescription volume over patient health, with reports of inadequate risk communication to users.