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In June 2008, the BMJ published a case report of a suspected case of Reye’s syndrome associated with the use of an oral gel containing choline salicylate in a 20 month old child.  Following that, the UK health authority MHRA has recommended that topical oral pain relief products containing salicylate salts should be contraindicated in children and young people under the age of 16 years. As many choline salicylate-containing products in Singapore are OTC medication, PSS has recently issued the following communication to our colleagues.

Dear Pharmacy Managers & Membes,
 
On 21-Apr-09, UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued an advisory on the safety related advisory on oral salicylate gel use. This is linked to the risk of Reye’s Syndrome for patients under 16 years of age due to the serious side effect. Details of MHRA advisory can be read here
 
Following that, PSS Community Chapter has been in contact with HSA and will provide further guidance if there is any necessary. Meanwhile, we advise our fellow retail pharmacists not to be alarmed but be vigilant about recommending salicylate containing products. The currently registered products are:

1). Bonjela Gel SIN04303P 
Marketed By:  Reckitt Benckiser (Singapore) Pte Ltd
2). Ora-Sed Jel   SIN04948p 
Marketed By: IDS Pharmaceutical Division
3). Soragel Antiseptic Pain Relieving Oral Gel   SIN 10428p
Marketed By: Integrated Contract Manufacturing Pte Ltd
 
In case of any media queries, it is recommended that member:
a) follow your in-house corporate communication protocol  if it is a matter concerning your company/institution
b) you to forward to PSS if it is a professional matter with nation wide implication.
 
Please get back to me your follow-up on this matter. If there is any development, please get in touch with the Community Chapter or Ivan Chew directly.


PSS Community Chapter

 

 

 

 

 

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