Тем временем Бельгия встает на сторону Франции, которая утверждает, что — к черту EMA — польза от финастерида не перевешивает риски психических расстройств и сексуальной дисфункции.
16 июня 2025 г.
Дорогие друзья:
China just raised a gigantic red flag, joining France, Canada, Britian, Spain, Russia, and the US in their global march for PFS awareness.
Last week, researchers at the Chengdu Seventh People’s Hospital published a paper that stopped thisshort of proving finasteride causes brain fog.
Titled Association between finasteride with subjective memory deficits: a study from the NHANES and FAERS databases, the Frontiers in Neurology investigation was designed “to establish an evidence-based framework for clinical safety evaluation and therapeutic risk-benefit analysis.”
Hua Huang led a team of five fellow PhDs who mined two data sources: FAERS, the US Food and Drug Administration’s public database of adverse drug reactions (ADRs), and NHANES, the National Health and Nutrition Examination Survey, conducted annually by the US Centers for Disease Control and Prevention to measure Americans’ health through physical exams, lab tests, and interviews that include questions about prescription drugs, dietary supplements, dietary intake, and socioeconomic traits.
“Convergent evidence from both epidemiological studies and pharmacovigilance surveillance suggests a potential association between finasteride administration and cognitive dysfunction, particularly in memory-related domains,” writes Prof. Huang.
Convergent evidence, incidentally, is a method of evidence synthesis involving two or more independent data sources that reach the same conclusion, hypothesis, or explanation through different research methods. Though not proof of the causal relationship being investigated, it strengthens the validity of the investigation’s findings.
Damage identified
In all, the team found 640 cases of cognitive dysfunction associated with finasteride use, 114 from NHANES, reported between 2001 and 2018; and 526 from FAERS, reported between 2004 and 2018. Within the FAERS population, the reporting odds ratio (ROR) scores—which measured the potential links between finasteride and adverse drug reactions (ADRs)—were most intense for:
- Learning disorders (48.83)
- Cognitive disorders (30.85)
- Thought blocking (28.86)
- Illusion (18.51)
- Reading disorder (13.52)
- Disturbance in attention (11.88)
- Sensory loss (10.45)
- Dysphemia, aka stuttering (10.28)
“These high ROR values indicate substantial associations between finasteride use and specific neurocognitive impairments,” says Prof. Huang.
An ROR value of 10 or higher typically indicates a signal that calls for further investigation to confirm the link, and to assess causality. Signals, in turn, are detectable changes in pathology patterns that can indicate an epidemic.
Percentagewise, the leading finasteride-related memory dysfunctions within the FAERS population are:
- Cognitive disorder (31.1%)
- Disturbance in attention (17.8%)
- Memory impairment (13.8%)
- Amnesia (12.1%)
- Mental impairment (6.2%)
- Thinking abnormal (3.4%)
- Nervous system disorder (2.6%)
- Sensory loss (2.4%)
Repair hinted at
“Given this potential impact of finasteride on memory function, it is crucial to prioritize monitoring of cognitive status in clinical practice,” says Prof. Huang.
“Healthcare professionals should establish a comprehensive medication monitoring program, regularly assessing cognitive function—particularly memory—throughout the treatment period. This approach will ensure that any signs of cognitive impairment are promptly identified and addressed.”
Regarding the NHANES data on cognitive dysfunction, which offered a glimpse into potential routes for managing the respective aspects of PFS, Prof. Huang adds:
“Patients should be encouraged to adopt healthy lifestyle interventions, including a balanced diet, regular physical activity, sufficient sleep, and stress management strategies, all of which can help mitigate the risk of memory decline. Ultimately, tailored treatment and care plans should be developed based on individual differences, medication responses, and lifestyle factors to optimize overall health outcomes.”
Domino effect unfolding?
Meanwhile, another nation has joined France in opposing the recommendations handed down last month by the European Medicine Agency (EMA) following its investigation into the causal relationship between 5-alpha reductase inhibitors (5-ARIs) and suicidality.
Just four days after the EMA’s announcement, Belgium’s Federal Agency for Medicines and Health Products (FAMHP) issued a statement that read, in part:
The [EMA] concluded that a causal relationship between oral finasteride 1 mg and suicidal thoughts has been confirmed and that a positive benefit-risk ratio in the indication androgenic alopecia remains positive when appropriate risk mitigation measures are implemented.
However, analysis of the data clearly revealed new aspects of the risks associated with psychiatric disorders and sexual dysfunction. These risks significantly alter the safety profile of oral finasteride 1 mg for the approved indication for androgenic alopecia…
The expected benefits of stabilizing hair loss in this benign condition do not outweigh the severity of these risks, with potentially fatal consequences, in the target population of young, healthy patients.
Consequently, Belgium considers that the benefit-risk ratio of finasteride 1 mg in androgenic alopecia is negative.
FAMHP also noted that the oral form of finasteride 1 mg is no longer authorized in Belgium, and that it has informed the EMA of such through a separate, divergent opinion. That opinion will be published on the EMA website at the conclusion of its current finasteride-safety probe.
Finasteride was originally developed by Merck & Co., Inc., and first approved by the US Food and Drug Administration in 1993 as Proscar (5 mg, for enlarged prostate), and again in 1997, as Propecia (1 mg, for hair loss).
In June 2021, Merck spun off its Organon subsidiary as an independent public company (NYSE: OGN). Founded in the Netherlands in 1923, Organon bills itself as a “global health care company dedicated to making a world of difference for women, their families and the communities they care for.”
Among the Merck products Organon acquired in the deal were Proscar and Propecia. To report adverse events for either finasteride product, call the Organon Service Center at (844)674-3200, or email Service_Center@Organon.com.
Anyone living in the US who suffers from PFS should also report his or her symptoms to the US FDA. Anyone living outside the US who suffers from PFS should report his or her symptoms to the US FDA as well as to his or her local DRA, as directed on our Report Your Side Effects page.
If you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact the PFS Foundation as soon as possible via our Patient Support hotline: social@pfsfoundation.org
Thank you.