By Rolfe Winkler

The Food and Drug Administration on Tuesday posted a warning about generic forms of a popular hair-loss medication often sold by major telehealth companies including Hims, Keeps and Ro, citing reports of side effects including sexual dysfunction and suicidal thoughts.

The warning relates to a topical spray form of the drug finasteride, also known by the brand name Propecia. The FDA said it hasn't approved the sale of those topical forms of the drug, or any safety information related to them. Only the pill version is FDA-approved.

Telehealth companies market the topical form of the medicine in extensive social-media campaigns, often with limited or no side-effect information. Such advertising is legal because telehealth companies aren't required to follow the same regulations as drugmakers when advertising medicine, an issue two senators are trying to address with bipartisan legislation.

The FDA warning comes after a Wall Street Journal article in March described men who said they had suffered severe side effects after getting finasteride prescriptions from Hims and Keeps. Some of the men had used topical formulations.

Spokespeople for Hims and Keeps didn't immediately return requests for comment. A spokeswoman for Ro said the company includes safety information about topical finasteride on its website.

U.S. law allows specialized pharmacies to make versions of drugs that aren't approved by the FDA for patients whose needs aren't met by approved drug formulations.

A Hims spokeswoman previously said that the company communicates transparently with patients "about all essential details and safety information" and that customers can ask clinicians about side effects. A spokeswoman for Keeps previously said the company takes great care to disclose drug side effects on its website, with clinical messaging and on product packaging.

The FDA warning cited reports of side effects with the topical spray products that it said are consistent with those associated with finasteride pills, "such as erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido and testicular pain."

The FDA said some consumers reported that their doctors told them topical finasteride had no side effects. In some cases the side effects continued after consumers stopped using the product.

The FDA warning also noted that finasteride spray might increase exposure risk to others, especially women, who aren't supposed to come in contact with the drug because of potential birth defects in male fetuses.

Write to Rolfe Winkler at Rolfe.Winkler@wsj.com

(END) Dow Jones Newswires

April 23, 2025 09:00 ET (13:00 GMT)

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