Concerns Raised Over Finasteride’s Link to Depression and Suicide Risk
A recently published review of research suggests a potentially significant underestimation of the mental health risks associated with finasteride, a widely used drug for male pattern baldness. The paper, authored by Dr. Michael Brezis, points to a history of ignored warning signs and a lack of robust post-market surveillance, potentially contributing to a tragic toll of depression and suicide among users.
Approved by the Food and Drug Administration (FDA) in 1997, finasteride remains a popular treatment option, often marketed to young men seeking a solution for hair loss. However, the review estimates that hundreds of thousands of users may have experienced depression linked to the drug, with the potential for hundreds, or even more, deaths by suicide.
While the FDA acknowledged depression as a possible side affect in 2011 and added suicidality to the list in 2022, concerns were raised much earlier. Researchers began sounding alarms as early as 2002, and internal FDA documents from 2010 reveal redacted sections – marked “confidential” – containing estimates of potential user impact.
The review highlights a stark discrepancy between reported suicide rates and expected figures. By 2011, the FDA had recorded onyl 18 suicides potentially linked to finasteride. However, based on global usage data, Dr.Brezis argues the number shoudl have been in the thousands, indicating a “systemic failure of pharmacovigilance.”
A key factor, according to the review, may be the drug’s classification as a cosmetic treatment. Unlike medications for life-threatening conditions or psychiatric illnesses, finasteride has not been subject to the same level of intensive post-market scrutiny.Notably,the data-mining studies analyzed in the review were not initiated by Merck,the original manufacturer,nor requested by regulatory bodies.
Dr. Brezis contends that the drug’s purpose – addressing a non-life-threatening aesthetic concern – alters the acceptable level of risk. “This wasn’t about life or death medical necessity,” he stated. “This was about hair.”
The biological mechanism behind these potential mental health effects is believed to involve the drug’s impact on neurosteroids,such as allopregnanolone,which play a role in mood regulation. Animal studies have demonstrated long-term effects on neuroinflammation and even structural changes in the hippocampus.
Some patients report experiencing persistent symptoms even after discontinuing finasteride, a condition often referred to as “post-finasteride syndrome.” These symptoms can include insomnia, panic attacks, cognitive impairment, and ongoing suicidal thoughts.
The review is critical of both the FDA and Merck, asserting that despite access to extensive patient data and pharmacovigilance resources, neither entity took timely action. The author suggests the industry’s silence may have been motivated by market pressures and concerns about legal liability, drawing parallels to past controversies surrounding Merck’s handling of the drug Vioxx.
merck recently stated it’s commitment to patient safety, but the review points out that none of the safety studies cited were initiated by the manufacturer. The FDA, meanwhile, took five years to respond to a citizen petition requesting a black-box warning, ultimately adding suicidal ideation to the drug label without designating it as a formal warning.
Dr. Brezis is advocating for significant changes in the approval, monitoring, and prescription of drugs like finasteride. His recommendations include temporarily suspending marketing for cosmetic use until safety is re-evaluated, mandating post-approval studies with strict enforcement, and systematically recording drug histories in suicide investigations.
The paper concludes with a poignant dedication to a man who, after starting finasteride solely to improve his hair, quickly descended into severe psychiatric distress and ultimately took his own life.
