The FDA issued a public alert on Tuesday (22) about generic versions of a widely used medication for hair loss.
The agency cited 32 reports of adverse events involving compounded topical finasteride products, which are “potentially putting consumers at risk,” according to the agency.
These events include “erectile dysfunction, anxiety, suicidal thoughts, mental confusion, depression, fatigue, insomnia, decreased libido, and testicular pain”.
The alert specifically targets a finasteride spray formulation, the active ingredient also found in the oral medication Propecia.
According to the FDA, these topical versions have not received official approval and comprehensive safety data on them has not been submitted.
Currently, the only FDA-approved oral finasteride products are Proscar and Propecia.
The alert comes after a March report this year from the Wall Street Journal about men who experienced severe side effects after obtaining finasteride through a telemedicine company.
One of the men, 26-year-old U.S. Army Sergeant Mark Millich, began suffering from 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 experienced severe side effects after receiving the medication through a telehealth company believe they were adequately informed about the risks.
Unlike traditional pharmaceutical companies, telehealth service providers are not required to disclose side effects and other risks in their advertisements—although they claim to do so on their websites.
While telehealth companies have undoubtedly democratized the medication prescription process, medical experts have raised concerns about potentially inadequate patient evaluations and stated that they may prioritize prescription volume over the health and safety of their clients.
Sources: The New York Post and WSJ