News and Updates

Dramatic Developments in the Recognition of the Causal Link Between Propecia and Neuropsychiatric Side Effects

In recent months, significant new information has emerged regarding the risks associated with Propecia (Finasteride 1 mg). These developments have major implications for both the individual lawsuit and the class action currently handled by our firm in the Central District Court of Israel.

Our firm represents the estate of the late A.Z. The personal claim alleges that serious adverse effects called PFS (Post Finasteride Syndrome) caused him Neuropsychological soon after he took the drug. The claim supported by 6 expert opinions suggest  the manufacturer, Merck concealed information from the public and if the deceased has been warned and aware of those risks, he would not have taken the medication.

Propecia (Finasteride 1 mg), originally developed as a cosmetic solution for male-pattern baldness, is based on the clinical findings of the parent drug Finasteride 5 mg, intended for prostate treatment. Because Propecia was marketed as a cosmetic product, Merck rushed to promote it as a “miracle solution,” while disregarding known risks of sexual and neuropsychiatric adverse effects.

In 2010, Merck submitted a request to the  FDA to add “depression” as an adverse reaction in the patient leaflet. Despite the FDA pharmacology department’s recommendation to also include suicidal ideation, the manufacturer chose not to warn about the possibility of severe neuropsychiatric harm.
Over the years, Merck ignored numerous global publications warning of these risks and failed to update the leaflet accordingly. Even more concerning, the company did not properly warn prescribing physicians who act as the drug’s gatekeepers about the neuropsychiatric risks  associated with Propecia. As a result, both physicians and consumers were deprived of essential safety information, all while the manufacturer continued prioritizing profits.

The Post-Finasteride Syndrome Foundation – Dedicated to supporting research and finding treatments for PFS patients worldwide.

In 2016, the European Medicines Agency (EMA) conducted a review based on safety databases and published reports on neuropsychiatric adverse events. In 2017, EU member states updated patient leaflets to include warnings about anxiety, depression, and suicidal thoughts.
In Israel, these warnings were only added in 2020.
In the U.S., suicidality was recognized as an adverse effect only in 2022, after a petition submitted by the PFS Foundation in 2017.
Throughout this period, the manufacturer continued to deny any causal link between Propecia and neuropsychiatric symptoms, as well as the very existence of Post-Finasteride Syndrome (PFS), despite substantial scientific evidence.

In late 2024, the EMA launched a deeper regulatory review. Analysis of pharmacovigilance data identified a proven causal link between Propecia and suicidality, based on 313 reported cases of suicide and many additional cases lacking complete information.

In June 2025, the EMA instructed all 27 EU member states to formally add suicidality as a known adverse effect. The United Kingdom and France implemented the recommendation, with France adding a Black Box warning on the packaging—similar to cigarette warnings.

In March 2025 The CBC (Canadian Broadcast Cooperation) broadcast a story of a person that took his life

https://www.youtube.com/watch?v=l3Oz8gRgVNk

Despite receiving numerous complaints over the years, the Israeli Ministry of Health issued its first official warning to physicians only in August 2025, acknowledging the EMA findings and the causal link between Finasteride and suicidality. Sadly, this came too late for many who had taken the drug without being informed of its risks.

A recent scientific article written  by Prof. Mayer Brezis highlighted systemic failures in regulatory oversight of prescription medications. His conclusion supported by evidence-based medicine was that regulators (including the Ministry of Health, FDA, EMA, MHRA) often function as a “cat guarding the cream,” while pharmaceutical companies profit at the public’s expense.
https://acrobat.adobe.com/id/urn:aaid:sc:AP:2be33119-2156-4266-b60b-6d2f660f71bd

We will continue to publish updates on these dramatic developments regarding the safety of drugs, now-recognized causal link between Propecia and neuropsychiatric side effects (PFS), including anxiety, insomnia, depression, and suicidal thoughts—harm that could have been prevented had the manufacturer properly disclosed the risks and had the HMOs fulfilled their duty to protect public health rather than prioritizing global economic interests.

Our firm continues to advance both the individual claim and the class action on behalf of thousands of individuals harmed by Propecia and its generic equivalents, which have flooded the market without proper warnings.

The Post-Finasteride Syndrome Foundation – Dedicated to supporting research and finding treatments for PFS patients worldwide https://www.pfsfoundation.org/