Frisium®(clobazam): Update to include serious skin reactions in package insert for Malaysia

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Date: 25 April 2014

Description: A Direct Healthcare Professional Communication (DHPC) has been approved by NPCB to inform healthcare professionals of serious skin reactions, namely Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), associated with Frisium®.This product should be discontinued at the first sign of rash, unless the rash is clearly not drug-related.If signs or symptoms suggest a serious skin reaction, use of Frisium®(clobazam) should not be resumed and alternative therapy should be considered. Patients should be closely monitored for signs and symptoms of SJS/TEN, especially during the first 8 weeks of treatment or when re-introducing therapy.The package inserts for Frisium® will be updatedby sanofi-aventis (Malaysia) Sdn. Bhd. to reflect this new safety information. Please refer to the DHPC for further information.

National Pharmaceutical Regulatory Agency (NPRA)
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