For more than twenty years, finasteride, a widely used prescription drug aimed at treating male hair loss, has harbored troubling risks. Beneath its promise of hair restoration lie alarming potential side effects, including depression, anxiety, and, in some cases, suicidal tendencies.
A recent review by Prof. Mayer Brezis from the Hebrew University of Jerusalem indicates that the medical community has repeatedly failed to warn the public about the serious psychiatric dangers associated with finasteride. The review, published in The Journal of Clinical Psychiatry, evaluates data from eight significant studies conducted between 2017 and 2023, revealing a consistent trend: men using finasteride are at a much higher risk of experiencing mood disorders and having suicidal thoughts compared to those not on the medication. This data encompasses various countries and sources, including adverse event reports from the U.S. FDA and national health records from Sweden, Canada, and Israel.
“The evidence is no longer just anecdotal,” remarked Prof. Brezis, who holds a position in medicine and public health. “We’re observing consistent patterns across different populations, and the outcomes could be tragic.” According to the review, it’s possible that hundreds of thousands have encountered depression linked to finasteride use, with a significant number potentially having taken their own lives. Once approved by the FDA in 1997 for male pattern baldness, finasteride has been a common recommendation for young men, often advertised as a low-risk solution with high rewards.
However, critics argue that numerous warning signs were dismissed.
Delayed action with severe repercussions
The FDA acknowledged depression as a possible side effect in 2011 and added suicidality to the label in 2022, yet concerns had been raised as early as 2002. Internal documents from the FDA dating back to 2010, mentioned in Brezis’ review, include heavily redacted sections, for instance, estimates regarding the number of affected users.
By 2011, the FDA had recorded only 18 suicides connected to finasteride, but with a global usage estimate, that figure should have been in the thousands. “This wasn’t merely underreporting,” Dr. Brezis stated. “It reflects a systemic failure in drug safety monitoring.”
Unlike weight-loss or psychiatric medications that face close scrutiny after their release, finasteride’s classification as a cosmetic drug may have shielded it from thorough investigations. Notably, none of the studies referenced in Brezis’ analysis were conducted by Merck, the original manufacturer, nor were they requested by regulators.
A cosmetic treatment with profound risks
Brezis contends that classifying the drug as non-essential for medical reasons alters the risk assessment. “This was about hair, not an urgent medical necessity,” he pointed out. The way the drug functions is well understood; it hinders the conversion of testosterone into dihydrotestosterone (DHT), which may inadvertently disrupt neurosteroids like allopregnanolone—key to mood regulation in the brain. Animal research has indicated long-term impacts on neuroinflammation and changes in brain structure.
The aftereffects for some patients don’t resolve once they stop taking the pills. Symptoms that linger, often referred to as “post-finasteride syndrome,” can include insomnia, panic attacks, cognitive issues, and suicidal thoughts, lasting for months or even years.
Regulatory shortcomings and corporate silence
The review is sharply critical of both the FDA and Merck. Despite having comprehensive access to patient data and robust safety monitoring tools, neither entity took timely action, according to Brezis. He suggests that the industry’s reluctance to act was likely influenced by market dynamics and potential legal repercussions, echoing past controversies related to Merck’s management of Vioxx.
In a recent public statement, the company asserted, “The safety of our medicines is paramount to Organon.” However, none of the cited safety studies were launched by the manufacturer.
Meanwhile, the FDA took five years to respond to a plea for a black-box warning, ultimately deciding to add suicide ideation to the label without it being classified as a formal warning.
Brezis advocates for immediate reforms regarding the approval, oversight, and prescribing practices for drugs like finasteride. His recommendations include halting marketing for cosmetic reasons until safety can be assured, enforcing mandatory post-approval studies, and systematically documenting drug histories in suicide investigations.
For many affected individuals, these proposed changes may come too late.
The review is dedicated to a man who, once healthy, started taking finasteride merely to enhance his appearance. Within days, he fell into significant psychiatric turmoil and never recovered. Months later, he took his own life.
