The FDA issued a public alert on Tuesday concerning generic versions of a widely-used hair loss drug that is frequently distributed by popular telehealth brands like Hims and Keeps.
The agency cited 32 reports of adverse events that involved compounded topical finasteride products, which are “potentially putting consumers at risk.”
These events include “erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido and testicular pain.”
The alert specifically targets a spray-on formulation of finasteride, the active ingredient also found in the oral drug Propecia.
According to the FDA, these topical versions have not received official approval, and no comprehensive safety data has been submitted for them.
At this time, the only FDA-approved oral finasteride products are Proscar and Propecia.
The warning follows a Wall Street Journal report in March about men who experienced severe side effects after acquiring finasteride through a telehealth company.
One of the men, US Army Sgt. Mark Millich, 26, began dealing with anxiety, dizziness and slurred speech — and then things got even worse.
His sex drive plummeted, and his genitals shrank and changed shape. His doctor said it was due to the medication.
None of the 17 men the WSJ spoke to who had severe side effects from getting the drug through a telehealth company believe they were adequately informed of the risks.
Unlike traditional drug companies, telehealth service providers aren’t obligated to disclose side effects and other risks in their advertising — although they claim to do so on their websites.
A Hims spokesperson told the outlet their customers “go through a comprehensive intake that is reviewed by a licensed provider who makes a clinical determination about the patient’s eligibility for medication” and that they communicate “about all essential details and safety information.”
While telehealth companies have arguably democratized the prescription drug process, medical experts have raised concerns over their potentially insufficient patient evaluation and posited that they may prioritize prescription volume over the health and safety of their customers.
Dr. Jonathan Daly, an internal medicine physician who worked for Hims for two years, told the WSJ that he “felt like as a platform, it was more of the let’s go ahead and prescribe, get as many patients as we can to use medications from us.”
