FDA Cautions: Topical Hair Loss Treatments Linked to Erectile Dysfunction, Anxiety, and Brain Fog
In recent news, a significant FDA alert has highlighted adverse effects linked to the topical form of finasteride, a widely used hair loss medication. This information is crucial for anyone considering treatment for hair loss, as it underscores the importance of being aware of potential risks associated with medications. Understanding these side effects is essential before starting any new medication, especially one as impactful as finasteride.
The FDA issued a warning on April 22 regarding lasting side effects from topical finasteride, a medication typically prescribed for hair loss. This alert brings to light serious conditions including erectile dysfunction, anxiety, and brain fog. Such side effects may linger even after discontinuation of the treatment.
Finasteride is commonly known in its oral form as Propecia and Proscar. This medication works by preventing the body’s conversion of testosterone into dihydrotestosterone (DHT), a hormone linked to hair loss.
According to a report by Epic Research for NBC News, prescriptions for finasteride have surged by 200% among men aged 25 and older over the past seven years. This increase can be attributed to expanded access through telehealth platforms that offer both the pill and topical spray forms.
While taking finasteride isn’t inherently dangerous, researchers have linked the oral form to sexual, mental, and physical side effects. Interestingly, these side effects can persist in a condition known as post-finasteride syndrome (PFS).
The FDA alert stipulates that absorption of topical finasteride through the skin into the bloodstream is anticipated, with adverse events aligning with reactions from the approved oral forms. Additionally, many patients reported being unaware of these potential side effects prior to initiating treatment.
Dr. Ronda Farah, an associate professor of dermatology at the University of Minnesota Medical School, emphasizes that “one of the problems is that these topicals are available without seeing a dermatologist.” This reality raises concerns about the lack of patient education.
Reported Side Effects
Although the FDA approved Propecia and Proscar back in the 1990s, it has yet to approve any topical form of the drug. However, doctors may prescribe it off-label, a practice that remains legal in the U.S.
Dr. Deirdre Hooper, a board-certified dermatologist, notes that “topical finasteride has not undergone rigorous testing.” Compounding pharmacies typically create these topical versions, making them distinct from standard formulations.
The recent alert documented 32 cases of adverse events reported to the FDA between 2019 and 2024. The side effects included:
- Erectile dysfunction
- Anxiety
- Suicidal ideation
- Brain fog
- Depression
- Fatigue
- Insomnia
- Decreased libido
- Testicular pain
Some individuals who reported these effects expressed a desire for prior awareness. Dr. Hooper cautions, “I don’t think this is a drug that you should be able to get without speaking to a physician.” She also mentions that while she does not prescribe topical finasteride, she supports the use of oral versions after thorough discussions.
Before Getting a Prescription
Dr. Farah states that the 32 reported cases are likely an understatement, given how many individuals may experience PFS. Both doctors recommend consulting a healthcare professional before starting topical finasteride.
This advice is particularly relevant for those considering telehealth services, known for their convenience but lacking in face-to-face physician interaction. Dr. Hooper states, “I recommend against using an off-label product simply by purchasing it online.” A consultation—either in person or via telehealth—is always advisable.
Telehealth Companies’ Policies
Inquiries to three telehealth companies—Ro, Keeps, and Hims & Hers—clarified their protocols for informing patients about potential side effects of topical finasteride.
Ro did not provide details on how they inform patients, while Keeps mentioned that a video or telephone call isn’t mandatory. Nonetheless, they assert that prescriptions are given only after a review by a licensed clinician, and they aim to provide clear and consistent information about potential side effects throughout the patient experience.
Similarly, at Hims & Hers, an initial consultation isn’t required for topical finasteride prescriptions. Providers conduct an online evaluation and are available for ongoing communication regarding side effects and treatment.
The accessibility of finasteride through telehealth services raises concern among professionals. Dr. Hooper finds it alarming that patients can obtain these products without comprehensive physician discussions. “People can just click through a questionnaire and answer questions however they want,” she warns.
Understanding Personal Risks
It’s essential to recognize that not all individuals will react the same way to finasteride. Dr. Farah emphasizes that research on risk factors for persistent side effects is in its infancy. The variability between compounded products also complicates understanding potential adverse effects.
In conclusion, actively acknowledging the risks associated with topical medications is critical. Dr. Hooper stresses, “You can’t forget that your skin is a massive absorber, and applying something to your skin is not without risk.” It’s imperative for patients to thoroughly discuss their options and the associated risks with healthcare providers before proceeding with any treatment.
