Faa use of sedating antihistamines

The RASML entries will be worded to try and make this as clear as possible.

For historical reasons, paediatric-only antihistamine substances other than cetirizine and levocetirizine are not currently subject to a RASML requirement for a sedation warning.

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.

Medicines that are unscheduled or included in Schedules 2 or 3 of the SUSMP are collectively referred to either as ‘non-prescription medicines’, ‘over-the-counter medicines’ or 'OTC medicines'.

Consumers rely on information from their health practitioner, pharmacist and medicine label in order to use medicines safely and effectively.

Therefore, the TGA proposes that the RASML should now be updated to ensure that the warning appears more consistently on all of these products.

In regards to product labels the MSU article concluded that: 'In response to this safety concern, the TGA will be seeking to make the statement 'Do not give to children under two years of age' (which is currently a recommended statement in the applicable OTC guidelines) a mandatory warning statement on the labels of OTC liquid oral formulations of first-generation oral sedating antihistamines'.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.As is always the case for the RASML, more restrictive statements will also fulfil these requirements (e.g.where a medicine is only labelled for adults and children 12 years and older, the single statement' will suffice).

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