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Finasteride has long been a popular solution for the treatment of androgenic baldnesswhich has long been a very popular solution to stop hair loss. However, behind its apparent cosmetic success hides an alarming reality that has taken more than twenty years to receive greater attention: a significant association with depressionanxiety and suicide. The analysis. Published in the Journal of Clinical Psychiatry by Professor Mayer of the Hebrew University of Jerusalem, systematically reviews the accumulated evidence and exposes what he describes as “a systemic failure of pharmacovigilance.” The study concludes that both the drug’s manufacturer, Merck, and regulatory bodies, such as the US FDA, failed to take relevant action despite growing danger signals about serious health problems. The evidence. Although concerns about depression associated with finasteride arose as early as 2002, it was not until the last decade that the evidence became overwhelming following studies done after the product was marketed. Brezis’ analysis is based on eight large independent studies published between 2017 and 2023, which used two main methods: disproportionality analysis in adverse event reporting systems and analysis of massive health registry databases. The results. The study carried out in countries such as Sweden, Canada and Israel points to very consistent results: the use of finasteride is associated with a significantly higher risk of developing depression, anxiety and suicidal behavior. All of this with a good statistical significance that shows that it is not due to chance. The human cost of this two-decade delay is devastating. The report estimates that, globally, “hundreds of thousands of people may have suffered from depression, and hundreds, or even thousands, may have died by suicide.” The data. One of the main reasons why it took so long to react was the massive under-reporting of cases. In 2010, the FDA was already discussing internally the possibility of including depression as a side effect, but noted that reported suicides were lower than expected in such a large user population. Brezis’ analysis puts figures on this discrepancy: For 2011, with a base of 4.6 million users worldwide, between 6,440 and 12,880 suicides were expected over a period of 10 to 20 years. However, only 18 cases had been reported to the FDA system (FAERS). By 2024, reported suicides amounted to 320, compared to the 19,320 that would be expected over a 30-year period. FDA inaction. The report is especially critical of the manufacturer and the regulator. Despite suspicions, none of the eight studies analyzed were conducted by Merck or requested by the FDA. This is striking, since Merck itself had validated in 2006 the usefulness of the pharmacovigilance tools used in these investigations, concluding that they had “sufficient sensitivity and specificity.” For its part, the FDA was disconcertingly slow. In 2011 it recognized depression as an adverse effect and in 2022 it added suicidal ideation, but not as a formal warning on the label. It took the agency five years to respond to a citizen petition requesting the drug be removed from the market. Internal FDA documents from 2010 show entire sections redacted as “confidential,” hiding key data about the drug’s safety. The case in Europe. In addition to the report issued by the FDA, the European Medicines Agency (EMA) has also launched an alert following its research on this same medication and suicidal tendencies. This is something that the Spanish Agency for Medicines and Health Products (AEMPS) has collected on its website, pointing out that from now on the packages of finasteride 1 mg will include a patient information card with the aim of reinforcing these warnings. In France they wanted be much more critical with the recommendations made by the EMA to confront this serious problem. Specifically, they have pointed out that the introduction of this alert card or the dissemination of a letter to professionals is not enough. Especially considering that the latest recommendations made by the regulator have not reduced the incidence of suicidal ideation in treated patients. Because. The relationship between finasteride and mood disorders is not a simple correlation, but has a plausible biological basis. The drug inhibits the enzyme 5α-reductase, reducing the conversion of testosterone. This process also decreases the synthesis of brain neurosteroids, such as allopregnanolone, which are crucial for mood regulation. For some users, the effects do not go away when they stop treatment. The so-called “post-finasteride syndrome” describes severe neuropsychiatric symptoms that persist for months or years after stopping the drug. Call to action. Brezis emphasizes that, as it is a medicine for a cosmetic indication, the balance between benefit and risk is radically different. “It wasn’t about a life-or-death medical need. It was about the hair,” he emphasizes. Images | Nik Shuliahin 💛💙 In Xataka | A natural, safe and already approved sweetener for consumption: the new and unexpected solution against baldness