Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) 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 has 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 will now be sent to the European Commission for a final legally binding decision valid throughout the European Union (EU).

Diacerein is a medicine used to treat joint diseases such as osteoarthritis (swelling and pain in the joints). Following an EU-wide review of diacerein, its use has been restricted in order to minimise the risks of severe diarrhoea and liver problems.

The review of diacerein was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC). In November 2013, the PRAC initially recommended the suspension of the marketing authorisations for diacerein-containing medicines. However, following re-examination, the PRAC considered additional proposals to manage diacerein’s risks and was satisfied that with new restrictions diacerein’s benefits would outweigh its risks.

The PRAC’s final recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which endorsed the recommendations and adopted a position by majority vote.

The CMDh position will now be sent to the European Commission for an EU-wide legally binding decision.

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