Diacerein-containing medicines for oral administration

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

Overview

Restrictions to the use of diacerein-containing medicines

Restrictions intended to limit risks of severe diarrhoea and effects on the liver

On 19 March 2014, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)1 endorsed recommendations to restrict the use of diacerein-containing medicines in order to manage the risks of severe diarrhoea and effects on the liver.

Due to the risks associated with severe diarrhoea, diacerein is no longer recommended in patients aged 65 years and above. It is also advised that patients start treatment on half the normal dose (i.e. 50 mg daily instead of 100 mg) and should stop taking diacerein if diarrhoea occurs.

In addition, diacerein-containing medicines must now not be used in any patient with liver disease or a history of liver disease, and doctors should be monitoring their patients for early signs of liver problems.

Doctors should also note that, based on available data, the use of diacerein is to be limited to treating symptoms of osteoarthritis affecting the hip or knee. Treatment should only be started by doctors experienced in treating osteoarthritis.

These recommendations are based on the review of the benefits and risks of diacerein conducted by the EMA's Pharmacovigilance and Risk Assessment Committee (PRAC) and follow concerns raised by the French medicines agency (ANSM) about diacerein's gastro-intestinal and liver effects. The CMDh endorsed the PRAC's final recommendations to address these concerns and ensure that diacerein's benefits continue to outweigh its known risks.

As the CMDh position on diacerein was adopted by majority vote, it was sent to the European Commission which endorsed it and issued a final legally binding decision valid throughout the European Union (EU) on 4 September 2014.


1The CMDh is a medicines regulatory body representing the European Union (EU) Member States.

Key facts

About this medicine
Approved name
Diacerein-containing medicines for oral administration
International non-proprietary name (INN) or common name
diacerein
Associated names
Zondar
Class
-
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1349
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
29/11/2012
PRAC recommendation date
06/03/2014
EC decision date
04/09/2014
Outcome
Variation

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

European Commission final decision

  • List item

    Diacerein Article-31 referral - Restrictions to the use of diacerein-containing medicines (PDF/83.41 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014
    EMA/544268/2014

  • List item

    Diacerein Article-31 referral - Annex III (PDF/78.91 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014

  • List item

    Diacerein Article-31 referral - Restrictions to the use of diacerein-containing medicines (PDF/83.41 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014
    EMA/544268/2014

  • List item

    Diacerein Article-31 referral - Annex II (PDF/66.46 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014

  • List item

    Diacerein Article-31 referral - CMDh divergent position (PDF/50.37 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014

  • List item

    Diacerein Article-31 referral - PRAC assessment report (PDF/375.69 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014

  • List item

    Diacerein Article-31 referral - Annex I (PDF/105.42 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014

  • List item

    Diacerein Article-31 referral - Annex IV (PDF/16.7 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014

  • 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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