Faa use of sedating antihistamines bbc cherry goes dating
The RASML sets out the advisory statements that are required to be included on the labels of specified medicines. The RASML permits the wording of the actual statements that are included on medicine labels to differ from the wording set out in the RASML, as long as the intent is the same.The current version of the Specification is the Medicines Advisory Statements Specification 2017 (MASS 2017). First-generation antihistamines are available in a variety of doses and formulations.The MASS 2017 incorporates two versions of the RASML (currently RASML No. 4) as schedules 1 and 2, respectively, to allow for a transition period for adoption of new advisory statements onto medicine labels. They are widely used for treatment of allergic conditions, as well as for symptomatic relief of ‘cough, cold and flu’, and for insomnia.The following first-generation sedating antihistamines are included in Schedule 2 and/or Schedule 3 of the SUSMP (OTC medicines), subject to the requirement that they are not for treatment of children under 2 years of age: recent TGA Medicines Safety Update (MSU), Volume 9, No.1, February-March 2018 included an article reminding health professionals that first-generation oral sedating antihistamines are not approved for use in children under 2 years of age.The reminder followed a coronial hearing of a fatal case involving an infant being given OTC promethazine oral liquid.
where a medicine is only labelled for adults and children 12 years and older, the single statement' will suffice).
The TGA Labelling Orders require medicine labels to include 'warning statements' where these apply to the medicines, including any advisory statements specified in the instrument made under subsection 3(5A) of the ('the Act'), as in force from time to time.
The RASML is registered on the Federal Register of Legislative Instruments under subsection 3(5A) of the Act, as the Medicines Advisory Statements Specification ('the Specification'). The advisory statements required by the RASML are designed to inform consumers about specific risks related to the use of medicines that have been identified during development and evaluation of new medicines, or subsequent pharmacovigilance activities, testing, adverse event reports or from other scientific or clinical information.
However, the TGA considers that all paediatric-only sedating antihistamine products should be required to display a label statement advising care-givers that the medicine may cause drowsiness.
With this update, it is considered appropriate to now require the statement ' for all paediatric-only sedating-antihistamine medicines (as per the current requirement for cetirizine and levocetirizine).