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

  • 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.

    News

    How useful was this page?

    Add your rating
    Average
    1 rating