Cyproterone-containing medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh final position
Current status:
CMDh final position

Overview

Restrictions in use of cyproterone due to meningioma risk

On 13 February 2020, EMA’s safety committee (PRAC) recommended that medicines with daily doses of 10 mg or more of cyproterone should only be used for androgen-dependent conditions such as hirsutism (excessive hair growth), alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed. Once higher doses have started working, the dose should be gradually reduced to the lowest effective dose.

The medicines should only be used for reduction of sex drive in sexual deviations in men when other treatment options are not suitable.

There is no change in use of the medicines in men for prostate cancer.

The recommendations follow a review of the risk of the rare tumour meningioma with cyproterone. Overall, this side effect is rare: it may affect between 1 and 10 in 10,000 people, depending on the dose and duration of treatment. The risk increases with increasing cumulative doses (the total amount of medicine a patient has taken over time).

Available data do not indicate a risk for low-dose cyproterone medicines containing 1 or 2 milligrams cyproterone in combination with ethinylestradiol or estradiol valerate and used for acne, hirsutism, contraception, or hormone replacement therapy. However, as a precaution, they should not be used in people who have or have had a meningioma. This restriction is already in place for the higher dose medicines.

Doctors should monitor patients for symptoms of meningioma, which can include changes in vision, hearing loss or ringing in the ears, loss of smell, headaches, memory loss, seizures or weakness in arms and legs. If a patient is diagnosed with meningioma, treatment with cyproterone medicines must be stopped permanently.

As part of the ongoing surveillance of the safety of the medicines, companies marketing medicines containing 10 mg or more of cyproterone will be required to carry out a study to assess doctors’ awareness of the risk of meningioma and how to avoid it.

Meningioma is a rare tumour of the membranes covering the brain and spinal cord. It is usually non-malignant and is not considered to be a cancer, but due to their location in and around the brain and spinal cord, meningiomas can cause serious problems.

The PRAC recommendation was adopted by the CMDh by consensus and will be implemented directly at national level.

Key facts

About this medicine
Approved name
Cyproterone-containing medicinal products
International non-proprietary name (INN) or common name

cyproterone

Class
antiandrogens
About this procedure
Current status
CMDh final position
Reference number
EMEA/H/A-31/1488
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.

Decision making model
PRAC-CMDh
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
Procedure start date
11/07/2019
PRAC recommendation date
13/02/2020
CHMP opinion/CMDh position date
25/03/2020
Outcome
Variation

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

  • List item

    Cyproterone Article-31 referral - Restrictions in use of cyproterone due to meningioma risk (PDF/133.65 KB)


    First published: 27/03/2020
    Last updated: 20/05/2020
    EMA/147755/2020

  • List item

    Cyproterone Article-31 referral - Annex I (PDF/421.76 KB)


    First published: 20/05/2020

  • List item

    Cyproterone Article-31 referral - Annex II (PDF/181.09 KB)


    First published: 20/05/2020

  • List item

    Cyproterone Article-31 referral - Annex IV (PDF/84.48 KB)


    First published: 20/05/2020

  • List item

    Cyproterone Article-31 referral - PRAC assessment report (PDF/493.5 KB)

    Adopted

    First published: 01/04/2020
    EMA/134740/2020

  • List item

    Cyproterone Article-31 referral - Annex III (PDF/201.16 KB)


    First published: 27/03/2020
    Last updated: 20/05/2020

  • Document description

    • Annex I - List of the medicines affected by the referral
    • Annex II - Scientific conclusions of the CHMP or CMDh
    • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
    • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
    • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
    • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
    • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
    • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
    • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

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