FDA Issues Alert on Compounded Topical Finasteride Risks
The US Food and Drug Administration (FDA) said Tuesday it has become aware of reports of adverse events associated with compounded topical finasteride products, and it has issued an alert for healthcare providers, compounders, and consumers.
The agency is aware that some compounders and telemedicine platforms market topical finasteride either alone or with other active ingredients, such as finasteride combined with minoxidil, to treat hair loss, according to the alert.
There are only two FDA-approved oral finasteride products for different indications currently available in the United States: Proscar, approved in 1992, and Propecia, approved in 1997.
FDA-Approved Topical Finasteride Not Available
There is no FDA-approved topical formulation of finasteride, and compounded topical finasteride products do not have FDA-approved labeling, and “there are potential serious risks associated with the use of compounded topical finasteride products,” the FDA alert stated.
Between 2019 and 2024, 32 cases of adverse events associated with the use of compounded topical finasteride were reported to the FDA Adverse Event Reporting System. Reported adverse events include those “consistent with those associated with the approved oral finasteride products,” such as erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido, and testicular pain following the use of compounded topical products with finasteride alone or combined with other active ingredients, according to the alert.
Most of the reports stated that the adverse events continued after use of the product was stopped.
Some Report Symptoms ‘Ruined’ Lives
“In some cases, consumers expressed they were not aware of the potential adverse events associated with the use of topical finasteride, and other patients reported that they were told by the prescribers that there was no risk of any adverse event because the product was topical,” the alert stated. “Some consumers,” the alert added, said that they “became very depressed, suffering with pain, and their lives were ruined because of these symptoms.”
Topical finasteride is also associated with other risks than those listed for oral formulations, according to the alert, such as local irritation, erythema, dryness/scaling, stinging and burning, and greater potential risk for exposing others to the product.
Heightened Risk in Pregnant Women
Exposure can be especially harmful to women. Approved finasteride products are contraindicated in pregnancy because they may cause abnormalities in male fetuses. “Studies have shown that women should not handle crushed or broken finasteride tablets due to the possibility of absorption and the subsequent potential risk to a pregnancy,” the FDA stated.
FDA-approved finasteride tablets have a coating that prevents contact with finasteride during normal handling. But compounded topical finasteride products do not have a coating, and other compounded formulations may not have the coating.
Recommendations for Providers
The FDA recommends that healthcare providers educate patients on the risks of using compounded topical finasteride including the risks of inadvertently exposing pregnant women to the drug.
The FDA also encourages consumers, healthcare providers, and compounders to report adverse events or quality problems to the FDA at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Marcia Frellick is an independent, Chicago-based healthcare journalist.
