To the European Medicines Agency (EMA),

We, the undersigned, call upon the EMA to carefully consider the evidence before taking any steps to ban or restrict access to finasteride and dutasteride, medications widely used for the treatment of male pattern baldness and benign prostatic hyperplasia (BPH).

Background:
Finasteride and dutasteride have been proven to be effective treatments for millions of men around the world who suffer from these conditions. The benefits of these medications, particularly in improving the quality of life for those affected by male pattern hair loss and BPH, are significant and well-documented.

Recently, concerns have been raised regarding potential side effects, including alleged links to depression and suicidal ideation, leading to discussions about restricting or banning these medications within the European Union. However, these claims remain inconclusive and have not been substantiated by robust scientific evidence.

A systematic review and meta-analysis titled “5α-Reductase Inhibitors and Mental Health: A Systematic Review and Meta-Analysis” found no significant association between 5-ARI use and the risk of depression or suicide. Conclusion: "We found no evidence of an association between 5-ARI use and the risk of depression or suicide."

The U.S. Food and Drug Administration (FDA) has also reviewed available data and determined that there is no direct, scientifically proven link between finasteride or dutasteride and suicidal ideation. While some users may experience side effects, these are typically well-managed with proper medical supervision, and both medications remain essential treatment options for many.

Our Concerns:
We believe that banning or heavily restricting finasteride and dutasteride in the EU would:

Unnecessarily deny access to safe, effective medications for millions of people who rely on them.
Disregard the current scientific consensus, which shows no conclusive evidence of a direct link between these medications and suicidal ideation or severe mental health issues.
Limit treatment options, particularly for those suffering from male pattern baldness and BPH, conditions that can significantly affect self-esteem and quality of life.
Call to Action:
We urge the EMA to:

Review the existing body of scientific evidence, including findings from the FDA and other global regulatory bodies, which have not found conclusive links between finasteride, dutasteride, and severe mental health side effects.
Consider the needs of the many patients who benefit from these medications, who will be adversely impacted by any decisions to restrict or ban them.
Avoid unnecessary restrictions or bans, and instead continue to educate both doctors and patients about potential side effects while preserving access to these important medications.
Conclusion:
Finasteride and dutasteride have been safely used by millions of men for decades, and their risks are well understood and manageable. We ask the EMA to make decisions based on balanced, well-researched evidence, ensuring that those who benefit from these medications continue to have access to them without undue restrictions.

Let’s work together to preserve patient choice and access to effective treatments.

Sign this petition to urge the EMA to protect access to finasteride and dutasteride.