Diacerein (Art 50° or other) is a drug used in France for treating the symptoms of osteoarthritis of the hip and the knee. Its efficacy is unproven, and its adverse effects appear disproportionate: gastrointestinal disorders including diarrhoea, bleeding and stomach ulcer, pancreatitis, colitis; skin disorders and hypersensitivity reactions; sometimes fatal hepatobiliary damage.

In 2012, the French health products agency (ANSM) concluded that diacerein’s harm-benefit balance was unfavourable and applied to have it re-evaluated by the European Commission.

During the re-evaluation, a number of member states including France urged for the withdrawal of this drug from the market. The European Commission decided merely to restrict its use and to have these restrictions included on the patient leaflet for diacerein-based drugs: use not recommended for patients over the age of 65, contra-indication in patients suffering from liver disease, dosage reduced by half during the first 2 to 4 weeks of treatment, halting the treatment in the case of diarrhoea, etc.

At the beginning of 2015, despite the justified opposition of several member states, diacerein-based drugs remain on the European market, even though their harm-benefit balance is clearly unfavourable.

Osteoarthritic pain is sporadic and there is no known preventive treatment. Paracetamol is the first-line treatment for symptoms, and a nonsteroidal anti-inflammatory such as ibuprofen or naproxen is the second-line drug, in controlled doses. Diacerein should be ruled out.

©Prescrire 1 April 2015

"Diacerein. A controversial EU re-evaluation upholds marketing authorisation, unfortunately" Prescrire Int 2015; 24 (159): 94. (Pdf, subscribers only).