Clinical Quick Reference Monthly / May 2025 / Finasteride, Proceed With Caution?
EMA ISSUES NEW WARNINGS REGARDING FINASTERIDE USE
Advocacy groups have previously petitioned officials to stop selling the medication, pending advertisement of strong warnings.
On May 8th the EMA issued new guidance regarding the medication. This followed a comprehensive EU review of data concerning finasteride (and dutasteride). The EMA’s safety committee, PRAC, has identified suicidal ideation as a side effect linked to finasteride 1 and 5 mg tablets.
Sold in the U.S. under brand names such as Propecia, the medication has been used to treat male pattern hair loss and benign prostatic hyperplasia (BPH). (Finasteride was first introduced in 1992 for BPH. In 1997, it was approved for treatment of male pattern baldness.)
In April 2024, the The European Medicines Agency (EMA) issued a warning about finasteride, regarding the potential for suicidal ideation. The EMA advised healthcare professionals to monitor patients for mood changes and to advise them to stop treatment and seek medical advice if they experienced symptoms. This decision came after an EU-wide review and a warning by the UK’s Medicines and Healthcare products Regulatory Agency regarding possible psychiatric and sexual side effects.
U.S. Warnings
In 2011, the US FDA approved the addition of depression labeling for finasteride in the USA. There were at least 36 death cases in the US Food and Drug Administration's Adverse Event Reporting System database at the time for the medication.
A 2020 study presented by Michael S. Irwig shed light on common complaints that had been recorded in six patients utilizing finasteride for hair loss prior to their deaths. His research indicated a pattern of symptoms in all the cases being reviewed: insomnia and persistent sexual dysfunction.
Additionally, complaints of insomnia and tiredness had been noted as the most debilitating symptoms after using the drug. Record reviews indicated that apart from a patient with hyperlipidemia, there was no evidence of simultaneous medication usage alongside finasteride or any previously noted psychiatric diagnoses before initiating finasteride treatment.
According to government sources, finasteride was the 73rd most commonly prescribed medication in the United States in 2022, with more than 9 million prescriptions provided by clinicians.
COMMON SYMPTOMS?
The Mayo Clinic website for finasteride lists these symptoms below as “more common:”
Decreased interest in sexual intercourse
Inability to have or keep an erection
Loss in sexual ability, desire, drive, or performance
New EU Guidance & A Card
The EU and the UK will be introducing patient alert cards for finasteride hoping to raise awareness of the potential for psychiatric and sexual side effects.
The EU guidance as of May 8, 2025 includes the following language:
Finasteride tablets can cause depressed mood, depression or suicidal thoughts. If you are taking finasteride 1 mg tablets for hair loss and you experience any mood changes, stop taking finasteride and contact your doctor for further medical advice as soon as possible.
In some patients taking 1 mg finasteride tablets, problems with sexual function (such as less desire to have sex, difficulty having an erection and problems with ejaculation) may contribute to mood changes, including suicidal thoughts. If you experience problems with sexual function, contact your doctor for further medical advice.
TERMINOLOGY GUIDE
androgenetic alopecia - also known as male pattern or pattern baldness, is a common type of hair loss in both men and women, characterized by a gradual thinning of hair, often starting at the hairline or crown of the head.
BPH - Benign Prostatic Hyperplasia. A condition where the prostate gland, located below the bladder in men, enlarges without being cancerous.
EMA - The EMA EU, European Medicines Agency, is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines for both human and veterinary use. Its goal is to ensure the quality, safety, and efficacy of medicines available in the EU.
suicidal ideation - thoughts of suicide
988 Suicide & Crisis Lifeline - a national hotline offering one-on-one support for mental health, suicide, and substance use-related problems for anyone 24/7. No matter where you are in the United States, you can call or text the number 988 or chat online at 988lifeline.org and connect with a skilled crisis counselor.
The 988 Lifeline is a direct connection to immediate support and resources for anyone in crisis.
GUIDANCE DOCUMENTATION
MAYO CLINIC MED INFORMATION
https://www.mayoclinic.org/drugs-supplements/finasteride-oral-route/description/drg-20063819
SAMHSA Q&A on 988
https://www.samhsa.gov/mental-health/988/faqs#about-988
Disclaimer: The above study guide represents study materials; always seek and follow the advice of your medical provider for any acute or chronic medical issues or questions, and follow the protocols of your program or supervising agency.