The U.S. Food and Drug Administration has issued an urgent public warning regarding unapproved topical formulations of finasteride, the active ingredient in Propecia, citing multiple reports of serious side effects including suicidal thoughts, erectile dysfunction, and depression.
The agency's alert specifically targets compounded topical finasteride products frequently distributed by telehealth companies, noting it has received 32 reports of adverse events that are "potentially putting consumers at risk." The FDA emphasized that it has only approved oral versions of finasteride, not topical formulations.
Serious Side Effects Reported
According to the FDA warning, patients using topical finasteride have reported a range of concerning side effects similar to those associated with the oral medication, including:
- Erectile dysfunction
- Anxiety and depression
- Suicidal ideation
- "Brain fog" and cognitive issues
- Fatigue and insomnia
- Decreased libido
- Testicular pain
One case highlighted in a recent Wall Street Journal investigation involved 26-year-old U.S. Army Sgt. Mark Millich, who experienced anxiety, dizziness, and slurred speech after using finasteride obtained through a telehealth company. His condition deteriorated further with a dramatic decrease in sex drive and physical changes to his genitals that his doctor attributed to the medication.
Telehealth Marketing Practices Under Scrutiny
The FDA expressed particular concern about how telehealth companies market these products on social media platforms, often with minimal disclosure of potential side effects. Popular telehealth brands like Hims and Keeps have made these treatments widely accessible through online consultations.
Unlike traditional pharmaceutical companies, telehealth providers aren't subject to the same advertising regulations requiring disclosure of side effects, though they claim to provide safety information on their websites.
A spokesperson for Hims told reporters that 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."
However, the Wall Street Journal spoke with 17 men who experienced severe side effects after obtaining finasteride through telehealth services, none of whom believed they were adequately informed of the risks.
Compounded Medications vs. FDA-Approved Drugs
The FDA warning highlights the important distinction between FDA-approved medications and compounded drugs. Compounding pharmacies are legally permitted to create versions of FDA-approved drugs when the approved versions are in short supply, but these compounded medications don't undergo the same rigorous testing and regulatory scrutiny.
"At this time, the only FDA-approved oral finasteride products are Proscar and Propecia," the agency stated, emphasizing that no comprehensive safety data has been submitted for topical formulations.
Medical Use and Legitimate Applications
Finasteride is legitimately prescribed to treat male pattern hair loss (androgenetic alopecia) and benign prostatic hyperplasia (BPH), a condition caused by an enlarged prostate. When used as directed in its approved oral form and with proper medical supervision, it can be effective for these conditions.
Concerns About Telehealth Prescribing Practices
Medical experts have raised concerns that some telehealth companies may prioritize prescription volume over patient safety. Dr. Jonathan Daly, an internal medicine physician who worked for Hims for two years, told the Wall Street Journal 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."
While telehealth services have expanded access to medications for many patients, questions remain about the thoroughness of patient evaluations and the adequacy of risk communication in these streamlined digital healthcare models.
The FDA continues to monitor reports of adverse events associated with topical finasteride and urges healthcare providers and patients to report side effects to the FDA's MedWatch program.
