Counseling patients on safe hair loss options after FDA’s finasteride warning

Key takeaways:

• In April, the FDA issued an alert warning of potential serious risks associated with compounded topical finasteride sold by online platforms for hair loss.
• An expert shares what this means for patient care.

Topical formulations of finasteride are widely advertised as an option to treat hair loss in men and women, yet some formulations may pose serious health risks and have recently caught the FDA’s attention.

As Healio previously reported, on April 22, the FDA issued an alert of potential serious risks associated with the use of compounded topical finasteride, which is marketed by telemedicine platforms to treat hair loss but does not have agency-approved labeling.

According to the agency, there were 32 cases reported to the FDA Adverse Event Reporting System between 2019 and 2024 associated with the use these topical agents, most of which persisted after product discontinuation.

Healio spoke with Chris G. Adigun, MD, FAAD, a dermatologist at the Dermatology & Laser Center of Chapel Hill, about the risks of using compounded topical finasteride, hair loss treatment alternatives and the importance of closing the “information gap” for patients.

Healio: How often do you meet patients who are using non-FDA approved compounded topical finasteride. Who typically uses these products?

Adigun: I have had several patients come in already using topical finasteride dispensed by online platforms. However, I have had a sizable number of patients who have already started oral finasteride, also dispensed by online platforms.

These are well-funded online platforms that can advertise on prime-time TV, often during popular sporting events with wide audiences. In addition, they promote their websites through search engines for words such as “alopecia,” “male pattern hair loss” and more, so that when individuals are researching their condition, these websites will be at the top of their searches.

None of these patients who were able to acquire this medication online had been warned about the significant health risks, specifically for patients taking this medication for alopecia and are within the age range of 18 to 44 years.

Healio: What are the risks of using compounded topical finasteride products?

Adigun: The risks for topical finasteride are identical to those for oral finasteride. The incidence rates of these adverse effects are present but lower than those from the oral finasteride because transcutaneous absorption of topical finasteride — although not zero — is still lower than oral finasteride.

According to a case-controlled pharmacovigilance study using VigiBase, WHO’s global database, adults aged 18 to 44 years taking oral finasteride for alopecia had significantly higher rates of suicidal ideation and other psychological adverse events. Although I do still prescribe oral finasteride to treat alopecia, I make sure my patients are aware of these risks, including additional known potential adverse effects such as erectile dysfunction and other sexual adverse effects.

Hair loss itself is extraordinarily distressing. Finasteride has data to support its use for androgenetic alopecia, although it does not come without risk. After counseling patients extensively on the risks and benefits, they are then informed patients able to make the best decision for themselves.

What I find disruptive to patient care is when these medications are dispensed to them in the absence of this vital counseling step. Although these risks in the topical formulation are lower given the lower rates of absorption, they are still present. Patients need to be aware of what the potential risks are — big or small.

Healio: Is oral finasteride a better alternative? If not, what treatments are better alternatives than compounded topical finasteride?

Adigun: From a risk standpoint, oral finasteride carries greater risk of these adverse effects than topical finasteride. Oral finasteride also carries stronger data for hair growth than topical finasteride and has the added benefit of FDA approval. There is only one other FDA approved treatment for hair loss, and that is topical minoxidil (2% for women and 5% for men).

However, we employ other therapeutic options for these patients that are not FDA approved, such as oral minoxidil, oral spironolactone and injectable platelet-rich plasma all of which have data to support their use in different hair loss conditions.

Healio: What is driving patients to buy non-FDA–approved hair loss products? Why do you think they use these products instead of FDA–approved options?

Adigun: There are very few FDA-approved products for hair loss. In addition, the FDA-approved products do not yield results for everyone. As a result, doctors will prescribe or recommend therapies that have data to support their use for hair loss but may not have FDA approval specifically for hair loss.

Healio: What advice do you have for dermatologists when it comes to educating patients on the risks of using these products?

Adigun: All treatments for hair loss carry risk, and patients need doctors to counsel them on these risks so that they can make informed decisions for their health care. This appears to be a major gap in these online platforms that are dispensing medications such as oral and topical finasteride without counseling patients on their status of FDA approval and potential adverse effect profile.

Patients with hair loss are vulnerable because hair loss is distressing and carries social stigma, which will lead patients to trust these online platforms. We can help close this information gap for patients to empower them to better manage this often-chronic condition.

For more information:

Chris G. Adigun, MD, FAAD, can be reached at contact@dlcofchapelhill.com.