FDA Warns Of Depression, Erectile Dysfunction From Ingredient In Popular Hair-Loss Drugs

Watch what’s in your hair-loss creams and serums; it could wreck your health. The U.S. Food and Drug Administration (FDA) has issued a stark warning, cautioning consumers about serious side effects linked to an active ingredient in popular hair-loss medications, with risks ranging from brain fog and depression to erectile dysfunction and even suicidal thoughts.

Since 2019, the FDA has received 32 reports of adverse events linked to compounded topical finasteride, a custom-made version of the drug prepared by pharmacies for direct application to the scalp. The side effects were reported when this was used as a single active ingredient or in combination with other ingredients such as minoxidil for treating hair loss.

Currently, the only finasteride products officially approved by the FDA are oral pills: Proscar and Propecia, intended for specific medical uses like treating enlarged prostate or male pattern baldness. However, no topical version of finasteride has received FDA approval.

Absorption of finasteride through the skin and into the bloodstream is expected, according to the FDA. Reported side effects from compounded topical products are similar to those seen with approved oral versions. These include “erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido, and testicular pain,” the news release stated.

A more concerning reveal was that the adverse events continued even after patients stopped using the medications. In some cases, consumers reported they were unaware of the potential side effects linked to topical finasteride, while others were assured by the prescribers that there was no risk of adverse events, as it is applied topically.

“Consumers should consult with health care providers and compounders regarding potential risks prior to initiation of treatment using compounded topical finasteride,” the FDA warns.

Topical finasteride can also cause local reactions like irritation, redness, dryness, stinging, and burning. Since it is applied to the skin, it can easily be transferred to others, potentially posing a risk of unintentional exposure, especially to females. Finasteride products are not recommended during pregnancy because they can cause birth defects in male fetuses.

The FDA urges consumers, healthcare providers, and compounders to report any adverse events or quality issues with compounded drugs, including topical finasteride, through the MedWatch Adverse Event Reporting program online or by faxing it to 1-800-FDA-0178.