FDA issues warning on hair-loss treatment sold on Hims & Hers
The FDA warning letter doesn’t prevent the company from continuing to sell the treatment, but may be a sign of future enforcement.
The Food and Drug Administration issued a warning over topical finasteride, a topical hair-loss treatment sold by telehealth providers like Hims & Hers.
The FDA has approved two oral finasteride treatments but has not approved any topical treatments that typically come in a spray format. The FDA warning letter doesn’t prevent the company from continuing to sell the treatment, but may be a sign of future enforcement.
The FDA noted that patients reported not being warned about side effects. Unlike drugmakers, telehealth companies like Hims do not have to disclose side effects in their advertisements. The process of getting a prescription through platforms like Hims often takes just a few minutes.
The agency said it received 32 adverse effect reports for topical finasteride from 2019 to 2024. “In the reports, consumers said they wished they had been informed about the possible side effects,” the warning said. “Some consumers expressed they became very depressed, suffering with pain and their lives were ruined because of these symptoms.”
Hims did not immediately respond to a request for comment.
Last month, in a Wall Street Journal story highlighting patients who had negative experiences with topical finasteride, a Hims spokesperson said the company is transparent with patients about side effects.
Hims — the only one of its peers that’s publicly traded — was down about half a point on the news, about three points lower than its intraday high.
