FDA Flags Dangerous Hair-Loss Product
Using a medicated spray to combat hair loss may appear to be a simple solution, but some individuals say it has caused unexpected and severe side effects—including depression, sexual dysfunction, and suicidal thoughts. In light of these concerns, the U.S. Food and Drug Administration (FDA) has issued a public warning regarding the safety of these products.
The warning centers on a topical version of finasteride, a drug commonly sold by telehealth platforms such as Hims, Keeps, and Ro. While the oral form of finasteride, marketed under the name Propecia, is FDA-approved for treating hair loss, the spray form is not approved for this use. According to an April 22 statement, the FDA has received reports of adverse effects linked to compounded topical finasteride products, which lack FDA-approved labeling and safety evaluation.
Users of the spray have reported a variety of troubling symptoms, including erectile dysfunction, anxiety, insomnia, brain fog, and low libido. Some even reported experiencing suicidal thoughts. Additionally, the FDA cautioned that the medication poses potential risks to women, especially those who are pregnant, as exposure to finasteride can lead to birth defects in male fetuses.
Despite these risks, telehealth companies are legally permitted to distribute these spray formulations through compounding pharmacies, which can produce alternative versions of medications when needed. However, these products do not undergo the same scrutiny as FDA-approved drugs, and the marketing of such compounded treatments is subject to looser regulations.
Companies like Hims and Keeps have stated that they disclose the potential risks associated with topical finasteride on their websites and product packaging. Nonetheless, some users have claimed they were told by healthcare providers that the spray would not cause side effects, highlighting a gap in communication and understanding about the medication’s safety profile.
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