ADR that result in revision of patient information
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| European Union: CMDh endorsed recommendations to restrict the use of diacerein-containing medicines |
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The 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 European Medicines Agency’s (EMA) 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.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002049.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there is one registered pharmaceutical product containing diacerein, namely Artrodar Cap 50mg (HK-56190). It is a prescription-only medicine and indicated for improving the pain and function in patients with osteoarthritis. Recommendations about suspension of diacerein-containing medicines had been released by EMA and was posted on the Drug Office website on 9 November 2013. A letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 9 November 2013. In view of EMA’s new recommendation to remain the drug available but with restrictions, a letter to inform healthcare professionals regarding the restricted use of the drug will be issued and the matter will be discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, March 22, 2014
Issued at HKT 12:00
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