In recent months, the European Medicines Agency (EMA) has initiated a safety review of medicines containing finasteride and dutasteride, two active ingredients widely used to treat androgenetic alopecia and benign prostatic hyperplasia. This review focuses on potential psychiatric side effects, such as mood changes or suicidal ideation, reported in a limited number of cases.

At our clinic, Instituto Médico del Prado, under the direction of Dr. Espinosa Custodio, we would like to convey a message of reassurance and provide clear, rigorous and empathetic information, reaffirming our commitment to patient safety and ongoing support.

What Is the EMA evaluating regarding finasteride and dutasteride?

The EMA review, led by its Pharmacovigilance Risk Assessment Committee (PRAC), focuses on analysing possible psychiatric side effects associated with finasteride and dutasteride, including depression, anxiety, or suicidal ideation. The evaluation takes into account both clinical trial data and spontaneous reports from patients and healthcare professionals.

A total of 325 cases of suicidal ideation have been investigated: 313 linked to finasteride (most involving treatment for androgenetic alopecia) and 13 to dutasteride. These numbers must be interpreted within the context of very widespread use: it is estimated that cumulative exposure to finasteride exceeds 270 million patient-treatment years, and dutasteride more than 82 million. While it is essential to study any potential risks, reported cases remain extremely rare, and no direct causal relationship has been established to date.

EMA review of finasteride and dutasteride, should I be concerned?

In the vast majority of cases, both finasteride and dutasteride are safe, effective, and well-tolerated treatments for hair loss. However, as with any medication, proper medical supervision is essential. If symptoms such as mood changes, persistent sadness, or unexplained anxiety appear during treatment, we strongly recommend consulting your specialist.

At Instituto Médico del Prado, we evaluate each case individually and are available to address any concerns, ensuring a safe, personalised, evidence-based approach. As part of our protocol, we perform blood tests with hormonal panels to determine the appropriate dosage for each patient.

Transparency, safety and confidence in hair loss treatments

From a medical perspective, we welcome any initiative that enhances the safety of treatments and strengthens patient confidence. The EMA’s review of finasteride and dutasteride helps update the available information, raise awareness about rare potential side effects, and promote open dialogue between doctor and patient. Far from causing alarm, this process should be seen as part of a continuous improvement effort in the use of long-established medicines, widely prescribed and supported by years of clinical experience.

Our commitment: clear information and professional support

At our clinic, we closely monitor all recommendations issued by agencies such as the EMA to ensure that treatments are up to date, safe, and tailored to each patient’s individual needs. If you are currently taking finasteride or dutasteride, or are considering starting treatment for hair loss, we encourage you to speak with our medical team. We are here to listen, guide you, and offer a personalised plan based on scientific evidence and delivered with professionalism and care.

Dr. Espinosa Custodio works at the Instituto Médico del Prado, his hair clinic in Madrid or in Mexico City. If you wish to schedule an appointment, you can contact us at the phone number +34 912 468 664, on WhatsApp +34 627 396 322, or through the contact page on our website. If you are contacting us from Mexico, our phone number is +52 55 4590 9909.