Artrodar®50mg (diacerein): New restrictions of use to limit the risk of severe diarrhoea and effects on the liver

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Date: 12 February 2015

Description:

A Direct Healthcare Professional Communication (DHPC) has been approved by NPCB to inform healthcare professionals of the risk of severe diarrhoea and hepatotoxicity with the osteoarthritis medication, Artrodar® (diacerein). The use has been restricted to minimise these risks, including tightening of indication and recommending a lower starting dose.The package inserts for Artrodar® will be updated by TRB Chemedica Malaysia Sdn. Bhd.to reflect these safety changes. Please refer to the DHPC for further information.

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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