
An analysis of several studies published between 2017 and 2023 concluded that there is a link between hair loss treatments using finasteride and an increase in depression and suicidal thoughts.
A new report published in the Journal of Clinical Psychiatry is raising serious concerns about the long-term safety of finasteridea medication prescribed to millions of men since the 1990s to treat hair loss and enlarged prostates.
The investigation suggests that regulators and manufacturers may have ignored growing evidence of the potential psychiatric side effects of the medication, including depression, anxiety and suicidal thoughts, for more than two decades, says .
The review looked at eight studies published between 2017 and 2023, incorporating data from multiple countries, and concluded that people taking finasteride face a significantly higher risk of developing mood disorders and suicidal ideation compared to non-users.
“The evidence is no longer random,” said Mayer Brezis, lead author of the study. “Now we see consistent standards in diverse populations. And the consequences could have been tragic.”
Finasteride, sold under brand names such as Propecia and Proscar, works by blocking the conversion of testosterone to dihydrotestosterone (DHT), which causes hair loss. However, this same process also reduces levels of mood-regulating neurosteroids, such as allopregnanolone. Animal studies have demonstrated links between the drug and long-term changes in brain structure and inflammation, suggesting possible biological mechanisms behind the psychiatric effects.
Although the US regulator added depression to finasteride’s warning label in 2011 and suicidality in 2022, Brezis stresses that the agency’s own experts recommended including suicide risks as early as 2010. Internal documents allegedly show that this recommendation was discarded without explanationand important details were kept confidential.
In 2011, the FDA had documented just 18 suicides linked to finasteride, but based on the drug’s widespread use, Brezis estimates the true number could be higher. be in the thousands and that this discrepancy is due to what he calls a “systemic pharmacovigilance failure”.
Recently, INFARMED also discussed these medicines.
Brezis argues that such failures highlight the need for more rigorous and legally binding post-approval monitoring. “Before approving a medicine for the market,” he writes, “regulatory entities must require manufacturers to commit to carry out and disseminate safety studies ongoing — and this requirement must be met.”
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