PRAC Recommends Suspending Drugs With Diacerein

Larry Hand

November 08, 2013

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended suspending the use of diacerein-containing medicines across the European Union, saying the risks, including diarrhea and liver damage, outweigh the benefits for treating osteoarthritis.

The PRAC took up the review of diacerein, which is not marketed in the United States, in November 2012 after the French medicines agency ANSM voiced concerns about the frequency and severity of gastrointestinal side effects. The French agency also questioned the possible benefits of the medication for osteoarthritis, considering them "weak," according to a news release.

Diacerein is in a class of substances called anthraquinones. A slow-acting drug, it is intended to block actions of interleukin-1 beta protein, which, through cartilage destruction and inflammation, may be involved in development of degenerative joint diseases such as osteoarthritis.

The PRAC concluded that the number of cases of diarrhea from use of diacerein was high, particularly cases of severe diarrhea that sometimes led to further complications. The committee also considered reports of liver problems from patients taking the drug.

The PRAC also concluded that benefits were limited and did not outweigh the risks, and that use of the drug be suspended "until convincing evidence of a positive benefit-risk balance in a specific patient population is provided," according to the news release.

The recommendation will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures–Human for consideration at its December 16-18, 2013, meeting.

Because the companies that market diacerein have the right to ask for a re-examination of the PRAC's recommendation within 15 days, there could be a delay to the finalization of this review.


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