The EMA Pharmacovigilance Risk Assessment Committee (Prac) has recommended the suspension of medicinal products containing diacerein in Europe. Diacerein is marketed in France under the names Art 50 and Zondar and has been authorized since 1992 for the treatment of hip osteoarthritis and knee.
Intestinal and hepatic disorders
In 2008, following a re-evaluation process for anti-arthritis drugs, the French Medicines Agency (ANSM) showed the persistent adverse effects of these diacerein-based drugs (severe and frequent gastrointestinal effects and rare but sometimes serious hepatic). At the same time, the efficacy on pain and the functional improvement of osteoarthritis has only been poorly demonstrated. On July 12, 2012, France wished to bring this file to the European level and requested an examination of the PRAC.
Today, the Committee confirmed its concerns and considered the benefit-risk ratio of these drugs to be unfavorable, due to their limited efficacy and their gastrointestinal and hepatic side effects.
The PRAC recommendation in favor of a suspension of the marketing authorization will be examined by the coordination group which represents the various national drug agencies in the countries of Europe (CMDh) in December.
ASNM recommendations
The ANSM recommends that healthcare professionals do not wait for the end of the regulatory process. They must now take the results of this evaluation into account in their daily practice, and no longer initiate treatment with diacerein and instead choose, when necessary, a relay with other drugs in patients currently under treatment.
The role of the Prac
The Pharmacovigilance Risk Assessment Committee (PRAC) has a major role in the monitoring of medicinal products within the European Union. It reassesses the benefit-risk ratio of medicines, also examines new alerts, safety studies after marketing authorization (MA), periodic safety reports, risk management plans (RMP) and results of pharmacovigilance inspections.