Published: 27 March 2014

Consultations

Outcome of consultation on the proposed planned changes to the Label Statements Database for aspirin

About the consultation

In December 2013, Medsafe published a proposed change to the Label Statements Database for aspirin on the Medsafe website, and sought feedback on the proposal by 3 March 2014.

Consultation

Medsafe proposed that the current Label Statements Database entry for aspirin be modified to harmonise with Australia. Under the current Label Statements Database entry, sponsors of aspirin products can choose between the following warning statements:

•  do not use in children under 12 years of age except on doctor's advice

or

• unless a doctor has told you to, do not use this product in children under 12 years of age or teenagers with chickenpox, influenza or fever.

To harmonise with Australia, Medsafe proposed that the Label Statements Database should be amended to just the latter option:

•  unless a doctor has told you to, do not use this product in children under 12 years of age or teenagers with chickenpox, influenza or fever.

Consultation feedback

One submission was received.  The submitter questioned where the complete statement “unless a doctor has told you to, do not use this product in children under 12 years of age or teenagers with chickenpox, influenza or fever” appears in the Australian regulations.

Medsafe notes that the Australian Required Advisory Statements for Medicines Labels (RASML) statement 10, required on the labels of aspirin products, is “Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever”, which has been in effect since 23 June 2004.

Implementation

The Label Statements Database will be amended so that the warning statement “do not use in children under 12 years of age except on doctor's advice” for aspirin products is removed. From 1 June 2014, all new medicines will be required to include the warning statement “unless a doctor has told you to, do not use this product in children under 12 years of age or teenagers with chickenpox, influenza or fever”. Sponsors of current products should consider including this change when they update their current labelling.

Enquiries

Any questions relating to this consultation should be directed via email to: askmedsafe@health.govt.nz