The US Food and Drug Administration (FDA) has issued a public warning highlighting serious side effects linked to compounded topical finasteride products sold via telehealth platforms like Hims & Hers and Ro, raising concerns over consumer safety and regulatory oversight.

Key Highlights

FDA Issues Warning on Topical Finasteride

• The FDA documented 32 adverse events from 2019 to 2024 attributed to compounded topical finasteride.

• Side effects most often reported are depression, dizziness, insomnia, fatigue, and decreased libido.

Topical Forms Not FDA-Approved

• The FDA explained that it has not approved any topical forms of finasteride.

• Telehealth companies' products are marketed without the thorough safety testing necessary for FDA-approved medications.

Customers Often Misinformed About Dangers

• Numerous patients allegedly did not realize the possibility of severe systemic side effects.

• Several telehealth clinicians minimized or overstated the risk of topical use.

Possible Further Risks

• Local side effects including skin irritation, dryness, and burning were also documented.

• There was concern regarding incidental transfer to others via skin contact, especially risky to pregnant females.

Post-Finasteride Syndrome (PFS) Debate Continues
A few users experienced enduring sexual and psychological impact, an contested condition called post-finasteride syndrome.

Quotations from Professionals and Authorities

• FDA Announcement: "These products are potentially putting consumers at risk," the FDA said, highlighting the absence of informed consent about significant side effects.

• Dr. Anthony Oro, Stanford Medicine: "There's no surprise about the side effects, because those are the same that have been observed with the oral medicine. The misunderstanding is that topical is safer, but systemic absorption can still happen."

• FDA Advisory: Healthcare professionals are encouraged to inform patients of the risks of compounded finasteride and provide adequate patient counseling.

The FDA notice highlights the expanding dangers of telehealth-dispensed, compounded medications. While availability increases across online channels, experts call for enhanced patient awareness and renewed prioritization of the doctor-patient relationship to minimize misuse and unsafe health consequences.