The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension of diacerein-containing medicines across the EU. This follows a review which concluded that the benefits of diacerein, used to treat symptoms of osteoarthritis and other degenerative joint diseases, did not outweigh its risks, particularly the risk of severe diarrhoea and potentially harmful effects on the liver.

The review was conducted at the request of the French medicines agency (ANSM) over concerns about the frequency and severity of gastro-intestinal side effects such as diarrhoea and liver disorders. In addition, the French agency considered the evidence of diacerein’s benefit in osteoarthritis to be weak.

Although diacerein is known to cause diarrhoea as a side effect, the PRAC concluded that there was a high number of cases, particularly of severe diarrhoea, which sometimes led to complications. The Committee was also concerned about liver problems that had been reported in some patients taking the medicine.

With regard to benefits, the PRAC considered that the available data showed the benefits of diacerein to be limited and it concluded that the benefits did not outweigh its risks. The PRAC therefore recommended that diacerein-containing medicines be suspended in the EU until convincing evidence of a positive benefit-risk balance in a specific patient population is provided.

The PRAC recommendation will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for consideration at its meeting on 16-18 December 2013.

Diacerein belongs to a class of substances called anthraquinones. It is a slow-acting medicine that blocks the actions of interleukin-1 beta, a protein involved in the cartilage destruction and inflammation which play a role in the development of symptoms of degenerative joint diseases such as osteoarthritis.

Diacerein-containing medicines are taken by mouth and are currently authorised in the following EU Member States: Austria, Czech Republic, France, Greece, Italy, Portugal, Slovakia and Spain.