Finasteride & Suicide Risk: Decades of Warnings Ignored | Hebrew University Study

Millions of men rely on finasteride to treat hair loss, but a growing body of evidence suggests a link between the drug and serious mental health consequences, including depression and, in some cases, suicide. A modern review published by a researcher at the Hebrew University of Jerusalem highlights how these concerns have been raised for over two decades, yet regulatory bodies and manufacturers have been slow to respond. The analysis, drawing on adverse event reports and healthcare records from multiple countries, points to a consistent pattern of psychiatric harm associated with finasteride use.

For over twenty years, finasteride – originally approved by the U.S. Food and Drug Administration (FDA) in 1997 for male pattern baldness – has been widely prescribed. While marketed for its cosmetic benefits, mounting evidence suggests a darker side. Professor Mayer Brezis, of the Hebrew University of Jerusalem’s Braun School of Public Health and Faculty of Medicine, argues that both the medical community and regulators have repeatedly overlooked signs of potential psychiatric harm. His review, published recently, compiles data from eight major studies conducted between 2017 and 2023, revealing a consistent trend: individuals taking finasteride were significantly more likely to experience mood disorders and suicidal thoughts compared to those not using the drug.

Evidence Across Borders and Databases

The findings aren’t isolated to a single region or data source. The review analyzed data from the FDA’s adverse event reporting system, as well as national healthcare records in Sweden, Canada, and Israel. “The evidence is no longer anecdotal,” Professor Brezis stated. “We now see consistent patterns across diverse populations. And the consequences may have been tragic.” The report estimates that hundreds of thousands of people may have suffered from depression related to finasteride use, with potentially hundreds more dying by suicide.

This isn’t a newly discovered issue. Researchers began warning of potential dangers as early as 2002, yet the response has been slow. Internal FDA files from 2010, cited in Brezis’ review, contained redacted sections estimating the potential impact on patients. By 2011, only 18 suicides linked to finasteride had been reported to the FDA. However, Brezis concluded, based on worldwide usage figures, that the actual number should have been in the thousands. He describes this as a “systemic failure of pharmacovigilance” – the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

A Cosmetic Treatment, A Different Standard?

One critical point raised by Brezis is the classification of finasteride as a cosmetic treatment. Unlike drugs used to treat life-threatening conditions, which are subject to rigorous post-approval monitoring, finasteride’s status as an appearance-enhancing medication may have shielded it from deeper scrutiny. None of the data-mining studies referenced in the review were initiated by Merck, the drug’s developer, or commissioned by regulatory authorities. As reported by the American Friends of the Hebrew University, Brezis argues that this classification changes the risk calculus, as the drug is used for non-essential purposes.

The biological mechanism behind this potential link involves finasteride’s action of blocking the conversion of testosterone into dihydrotestosterone (DHT). However, this process may also disrupt neurosteroids, such as allopregnanolone, which are linked to mood regulation in the brain. Animal studies have demonstrated long-term effects on neuroinflammation and even structural changes in the hippocampus, a brain region crucial for mood and memory.

Beyond Discontinuation: Post-Finasteride Syndrome

The concerns extend beyond the period of active drug use. Some patients report experiencing lingering symptoms – often referred to as “post-finasteride syndrome” – including insomnia, panic attacks, cognitive dysfunction, and persistent suicidal thoughts, even months or years after stopping treatment. The long-term effects and underlying mechanisms of this syndrome remain poorly understood, highlighting the need for further research.

A Delayed Regulatory Response

While the FDA recognized depression as a possible side effect in 2011 and added suicidal thoughts to the drug label in 2022, critics argue that this response was insufficient and came too late. The agency took five years to respond to a citizen petition calling for a “black box warning” – the most stringent warning placed on prescription drugs. The FDA opted to add suicidal ideation to the label, but not as a formal warning. Merck, in a public statement, maintains its commitment to patient safety, but has not initiated the safety studies referenced in the review.

What’s Next: Calls for Reform and Increased Vigilance

Professor Brezis is advocating for immediate changes in how drugs like finasteride are approved, monitored, and prescribed. His recommendations include suspending the marketing of the drug for cosmetic purposes until its safety can be re-established, mandating post-approval studies with strict enforcement, and implementing systematic recording of drug histories in suicide investigations. The British Friends of the Hebrew University also reported on these calls for reform.

The review serves as a stark reminder of the potential risks associated with even widely used medications. For individuals considering finasteride, a thorough discussion with a qualified healthcare professional about the potential benefits and risks is crucial. It’s also important to be aware of the potential for long-term side effects and to report any concerning symptoms to a doctor immediately. Ongoing pharmacovigilance and a commitment to transparency from both regulatory bodies and pharmaceutical companies are essential to protecting public health. The paper is dedicated to a man who experienced severe psychiatric distress after starting finasteride and ultimately took his own life – a tragic illustration of the potential consequences of overlooking these risks.

Further research is needed to fully understand the mechanisms underlying the link between finasteride and mental health issues, and to identify individuals who may be particularly vulnerable to these side effects. The FDA and other regulatory agencies are expected to review the findings of this study and consider whether additional measures are needed to protect patients.