THE Therapeutic Goods Administration has proposed undertaking a safety investigation of off-label use of a Schedule 2 brompheniramine/phenylephrine oral liquid indicated for allerginc rhinitis which is being used off-label for "cough and cold" indications in young children.
The move follows a submission to a consultation on new Required Advisory Statements for Medicine Labels (RASML) for sedating antihistamines.
The NSW Poisons Information Centre expressed concern about increasing numbers of accidental and therapeutic error exposures to sedating antihistamines in children aged 2-5.
The consultation has also seen planned new RASML for the class of medications set to be mandated from 01 Sep 2020 - tga.gov.au.
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