Finasteride- and dutasteride-containing medicinal products - referral

Current status
Under evaluation
ReferralHuman
  • Procedure started
  • Under evaluation
  • Recommendation provided by Pharmacovigilance Risk Assessment Committee
  • CMDh position
  • European Commission final decision

Overview

EMA started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviours.

Tablets containing 1 mg of finasteride and finasteride solution for application to the skin are used to treat the early stages of androgenic alopecia (hair loss due to male hormones) in men aged 18 to 41 years. Tablets containing 5 mg finasteride and capsules containing 0.5 mg dutasteride are used to treat men with benign prostatic hyperplasia (BPH), a condition in which the prostate is enlarged and can cause problems with the flow of urine.

During the review, PRAC will assess all available data linking finasteride and dutasteride to suicidal ideation and behaviours. It will also evaluate the impact of suicidal ideation and behaviours on the benefit-risk balance of these medicines, taking into consideration the conditions they are used to treat.

Medicines containing finasteride and dutasteride taken by mouth have a known risk of psychiatric side effects, including depression. Suicidal ideation has also recently been added as a possible side effect of unknown frequency in the product information for Propecia and Proscar, the first two finasteride-containing medicines authorised in several countries of the European Union (EU). To minimise the risks, measures are already in place for finasteride medicines, including warnings in the product information for healthcare professionals to monitor patients for psychiatric symptoms and stop treatment if symptoms occur, and recommendations for patients to seek medical advice if they experience psychiatric symptoms.

EMA will now review all available data on suicidal ideation and behaviours with finasteride and dutasteride and issue a recommendation on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU.

Medicines containing finasteride (1 mg tablets or spray to be applied to the skin) are authorised in various EU Member States to prevent hair loss and stimulate hair growth in men aged 18 to 41 years with early-stage androgenic alopecia (hair loss due to male hormones). In addition, medicines containing finasteride (5 mg tablets) and dutasteride (0.5 mg capsules) are authorised to treat symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate is enlarged, which may cause problems with the flow of urine.

In the EU, finasteride- and dutasteride-containing medicines are available as tablets or spray solutions under various trade names such as Propecia, Proscar, Fynzur, Avodart, Combodart, Dutaglandin, Androfin, Dupro, Duster, Andropecia, Adadut, Androfin, Prosterid, Finpros, Tadusta, Gefina, Dutascar, Finural, Finaristo, Finapil, Prosmin, Finapuren, Capila, Finahair, Duodart, Dutalosin and others.

Finasteride and dutasteride work by preventing an enzyme called 5-alpha reductase (5-AR) to change testosterone (a male hormone) into 5-alpha-dihydrotestosterone (DHT), which is involved in hair loss and enlargement of the prostate. By keeping 5-AR from working, finasteride and dutasteride decrease levels of DHT. This slows down hair loss and stimulates hair growth, and decreases the size of the prostate. 

The review of medicines containing finasteride and dutasteride has been initiated at the request of the French medicines agency (ANSM), under Article 31 of Directive 2001/83/EC.

The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. The PRAC recommendations will then be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position. The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.

Finasteride- and dutasteride-containing medicinal products Article-31 referral - Review started

Reference Number: EMA/452263/2024

English (EN) (146.65 KB - PDF)

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Key facts

About this medicine

Approved name
Finasteride- and dutasteride-containing medicinal products
International non-proprietary name (INN) or common name
  • finasteride
  • dutasteride
Class
genito-urinary system and sex hormones; dermatologicals

About this procedure

Current status
Under evaluation
Reference number
EMEA/H/A-31/1539
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Authorisation model
Nationally authorised product(s)
Decision making model
PRAC-CMDh

Key dates and outcomes

Procedure start date
03/10/2024

All documents

Procedure started

Finasteride- and dutasteride-containing medicinal products Article-31 referral - Annex I

DraftReference Number: EMA/454353/2024 rev1

English (EN) (971.14 KB - PDF)

First published: Last updated:
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Finasteride- and dutasteride-containing medicinal products Article-31 referral - PRAC list of questions

Reference Number: EMA/PRAC/414467/2024

English (EN) (168.11 KB - PDF)

First published:
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Finasteride- and dutasteride-containing medicinal products Article-31 referral - Timetable for the procedure

Reference Number: EMA/PRAC/414468/2024 Rev. 1

English (EN) (111.91 KB - PDF)

First published: Last updated:
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Finasteride- and dutasteride-containing medicinal products Article-31 referral - Notification

English (EN) (67.69 KB - PDF)

First published:
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Finasteride- and dutasteride-containing medicinal products Article-31 referral - Review started

Reference Number: EMA/452263/2024

English (EN) (146.65 KB - PDF)

First published:
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Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
  • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
  • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
  • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
  • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.

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