FDA Issues Warning About Unapproved Hair-Loss Spray Linked to Serious Side Effects

The U.S. Food and Drug Administration (FDA) has issued an alert regarding a topical hair-loss spray that is not approved by the agency and may pose significant health risks. While oral finasteride, marketed as Propecia, is an FDA-approved medication for treating hair loss, the spray form sold online by companies like Hims, Keeps, and Ro is not authorized and raises safety concerns. The FDA has received reports linking these compounded topical finasteride products to adverse effects such as erectile dysfunction, anxiety, suicidal thoughts, depression, brain fog, fatigue, insomnia, decreased libido, and testicular pain.

Compounded medications are custom-made by pharmacies when patients seek alternatives to approved drugs, but they are not subject to the same rigorous testing and standardization. The FDA emphasizes that there is currently no FDA-approved topical finasteride formulation, and compounded versions lack official labeling and safety data.

The warning also highlights the potential risks to others, especially women, as finasteride can cause birth defects in male infants. Women who handle the spray should be cautious and avoid contact with the drug. Despite some users being told by healthcare providers that the spray would not produce side effects, the FDA cautions that these products can indeed cause serious health issues.

This alert follows investigative reports revealing that some telehealth companies sell these unapproved sprays without full disclosure of the potential risks. While these companies operate legally, they are not bound by the advertising standards that govern traditional pharmaceutical companies. Both Hims and Keeps claim to provide customers with information about the risks involved.

Consumers are advised to consult healthcare professionals and rely on FDA-approved treatments for hair loss. For more detailed information, read the FDA's full health alert on compounded topical finasteride. Source: https://medicalxpress.com/news/2025-04-fda-unapproved-hair-loss-product.html