FDA Alerts Public on Risks Associated with Topical Finasteride for Hair Loss

FDA Alerts Public on Risks Associated with Topical Finasteride for Hair Loss

The U.S. Food and Drug Administration (FDA) just released this warning. They shine a light on the rare but serious adverse effects linked to topical finasteride, an emerging hair loss treatment. Available through telehealth platforms like Hims & Hers and Ro, this medication has gained traction among individuals seeking solutions for thinning hair. Yet patients’ adverse reactions to high adverse effects have led some to question its safety.

Mark Millich, 26, started taking topical finasteride before developing symptoms within the first few weeks that were alarming. His short-term treatment left him with frequent anxiety attacks, dizziness and slurred speech. His case isn’t unique—in fact, other users have shared the same experience. The FDA’s alert coincides with increasing criticism towards telehealth services that are inappropriately dispensing medications without a valid patient-provider relationship.

Adverse Effects and Lack of Approval

The FDA has not approved topical finasteride for hair loss. This uncertainty makes it difficult to assess the risks associated with using the treatment. According to Ro’s own website, those side effects include a long list of psychological and physiological symptoms—including many that qualify as severe. As reported by The Wall Street Journal, an investigation has highlighted numerous adverse effects reported by men who purchased topical finasteride through telehealth platforms.

Anthony Oro, MD, PhD, a dermatology expert at Stanford Medicine. He pointed out that the side effect profile of topical finasteride is consistent with the oral formulation of the drug. He stated, “Most of the side effects the FDA is seeing for topicals correspond to those that are known from the approved oral formulation. It’s not that there’s a new adverse side effect that are being reported.”

The Risks of Telehealth Solutions

As telehealth opportunities have expanded rapidly, medications like topical finasteride have become easier and more convenient to access. However, this convenience comes with potential drawbacks. Oro warned about the misconception surrounding topical medications, saying, “A lot of people have a misconception that because it’s topical it’s not going to be absorbed systemically.” He argued that it is absolutely imperative to have well-informed healthcare providers directing patients toward the best treatment decisions.

Several users have reported permanent side effects remaining even after stopping topical finasteride, a phenomenon known as post-finasteride syndrome (PFS). If left untreated, this condition can result in lasting sexual and psychological dysfunction. Oro remarked on the implications of quick access to these treatments: “There’s a trend now where you have access to medication without a long-term relationship between the patient and the provider, and we are seeing some of the ill effects of that now.”

Comparisons with Oral Finasteride

In fact, topical finasteride is promoted against its oral counterpart on sites like Ro. Although it is promoted as being safer because of its topical use, experts warn against this belief. Ro’s website claims that “because topical finasteride does not enter the bloodstream in the same way or quantity oral finasteride does,” it may carry a lower risk of systemic effects. Oro explains that this belief can foster deadly myths.

Oro noted that topical finasteride has a somewhat lower risk profile, in the view of some. At the same time, he cautioned that users should be vigilant against its unintended side effects. He stated, “The disconnect is that people may think because it’s topical that it’s safe and can be used widely at different concentrations without any problems.”

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