Petition update"Protect Access to Finasteride and Dutasteride: Oppose Unnecessary Restrictions or Bans"Your Voice Matters – Email the EMA to Save Finasteride!
Antonio De SimoneRoma, Italy
Mar 27, 2025

English:

Hello everyone,

We have reached 1,000+ signatures, and now it’s time to do more! As I told you, I have already contacted the EMA, and they confirmed that they will share my query with the committee.

Now, you can do the same! Simply copy and paste the draft below and send it to the EMA. The petition link is included in the email, so we can make our voices heard together.

You can send the email here: https://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency/send-question-european-medicines-agency

Let’s take action!

 
Italiano:

Ciao a tutti,

Abbiamo raggiunto oltre 1.000 firme, ed è il momento di fare di più! Come vi ho detto, ho già contattato l’EMA e mi hanno confermato che condivideranno la mia richiesta con il comitato.

Ora potete farlo anche voi! Basta copiare e incollare il testo qui sotto e inviarlo all’EMA. Il link della petizione è incluso nell’email, in modo che possiamo far sentire la nostra voce insieme.

Puoi mandare l'email qui: https://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency/send-question-european-medicines-agency

Agiamo subito!

 

Draft (copy and paste it and send it to: https://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency/send-question-european-medicines-agency

 

Subject: Urgent: Preserve Access to Oral Finasteride for Alopecia Treatment

Dear European Medicines Agency,

We are writing to express our deep concern regarding potential restrictions or a ban on finasteride and dutasteride, which are crucial treatments for male pattern baldness (androgenetic alopecia) and benign prostatic hyperplasia (BPH).

Finasteride remains the only approved oral treatment for male pattern baldness, a condition that can severely impact self-esteem and mental health. If access to this medication is restricted, many individuals will experience significant distress and depression, not due to the medication itself, but because they will be left without any effective treatment for their condition.

Furthermore, banning or limiting oral finasteride while keeping topical versions available is not an acceptable alternative. Patients have the right to choose the most effective form of treatment, and oral finasteride has been proven to be far superior to the topical version in efficacy and consistency. Denying access to the oral form disregards patient choice and forces individuals into a less effective option.

Additionally, banning or restricting finasteride would push people toward the grey market, where they may obtain the drug without medical supervision, increasing the risk of unsafe usage, counterfeit products, and health complications.

Scientific Evidence Does Not Support a Ban
A recent meta-analysis (2024) reviewed study data from over two million patients taking 5α-reductase inhibitors (5-ARIs) and found no significant association between 5-ARI use and the risk of depression or suicide:

"We found no statistically significant association between 5-ARI exposure and the risk of depression (adjusted hazard ratio [aHR] 1.30, 95% confidence interval [CI] 0.85-2.00; p = 0.23) or suicide (aHR 1.30, 95% CI 0.65-2.61; p = 0.45). When restricting the analysis to patients without a prior diagnosis of depression, we observed similar findings (aHR for suicide 1.00, 95% CI 0.68-1.46; p = 0.98)."


Furthermore, both the U.S. Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have reviewed the available data and found no conclusive link between finasteride and suicidal ideation. While all medications have potential side effects, these are well-documented and manageable under proper medical supervision. Restricting finasteride based on inconclusive claims would set a dangerous precedent by disregarding the established scientific consensus.

Public Response and Opposition
Thousands of patients and medical professionals are actively protesting against these potential restrictions. A formal petition has been launched to highlight the critical need for continued access to finasteride and dutasteride, emphasizing the lack of scientific basis for banning these treatments and the negative impact on patients who rely on them.

Petition Text:
https://www.change.org/p/protect-access-to-finasteride-and-dutasteride-oppose-unnecessary-restrictions-or-bans

We urge the EMA to carefully consider the scientific evidence, patient needs, and global regulatory positions before making any decision that would unjustly limit access to these essential medications.

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