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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 updated by sanofi-aventis (Malaysia) Sdn. Bhd. to reflect this new safety information. 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.

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