Proposed warning and advisory statement for ocular decongestants used for eye redness and/or minor eye irritation: Do not use in children under 12 years of age

Closed 23 Sep 2022

Opened 11 Jul 2022

Overview

This Medsafe consultation seeks your feedback on a proposed new warning and advisory statement for the package labelling of ocular decongestants. These are medicines that provide temporary relief of redness and/or minor irritation in the eyes through narrowing of swollen blood vessels.  

In June 2021, the Medicines Adverse Reaction Committee (the Committee) noted that the Clear Eyes (naphazoline) 0.01% eye drops package label did not have a lower age limit for use. The Committee expressed concerns that because Clear Eyes is a pharmacy-only medicine, it could be used in children under 12 years inappropriately without further investigation or adequate input from a healthcare professional. The New Zealand Formulary for Children recommends naphazoline should only be used in children 12 years and older. Therefore, the Committee recommended a Label Statements Database consultation to include this age limit on the package labelling.

Following this recommendation, Medsafe is extending this Label Statements Database consultation to include all ocular decongestants when used for eye redness and/or minor eye irritation. Other ocular decongestants available are tetrahydrozoline (tetryzoline) and phenylephrine.

The Label Statements Database lists the warning and advisory statements that are required on medicines and related package labelling. Currently, ocular decongestants are not required to have warning and advisory statements on the package labelling.

Because ocular decongestants are pharmacy-only or general sale medicines, they are not required to have a data sheet or a consumer medicine information leaflet. Instead, care givers and consumers must rely on the information on the package labelling. There is a risk that without adequate warnings on the label, these products may expose the child to unwanted harm. Safety concerns relating to use of ocular decongestants in children include the possibility of systemic effects and lack of safety and efficacy information.

At present, a lower age restriction for use is included on certain ocular decongestant package labelling:

  • Naphazoline: some package labels of naphazoline-containing eye drops state that they should not be used in children under 12 years of age, while other products do not have an age limit.
  • Tetrahydrozoline: the package labels of tetrahydrozoline-containing drops currently state that they should not be used in children under 6 years of age. 
  • Phenylephrine: currently there are no phenylephrine eye drops used for eye redness and/or minor eye irritation that are approved in NZ. Phenylephrine is also used for diagnostic procedures; products used for this purpose will not be required to have the proposed warning and advisory statement.

Medsafe is proposing that a lower age recommendation of 12 years old should be reflected across all ocular decongestant product labels.

Table 1 below shows the proposed warning and advisory statement for ocular decongestants.

Table 1: Proposed warning and advisory statements for ocular decongestants

Medicine/Group/Class Conditions Statement Required by
Decongestant, ocular
Examples include:
  • Naphazoline
  • Tetrahydrozoline (tetryzoline)
  • Phenylephrine

For ophthalmic use

When used for eye redness and/or minor eye irritation only

When used in combination with another medicine(s), the age limit for the combination product should reflect the highest age limit overall from each medicine

Do not use in children under 12 years of age

12 months from when the Label Statements Database is updated

 

Medsafe is seeking your feedback on:

  1. whether the package labels for ocular decongestants should contain a warning and advisory statement for an age restriction of use, whether a proposed age restriction of 12 years and under for all ocular decongestants is appropriate, the conditions the label statements will be applied to, and the required by (implementation) date (see Table 1).
  2. whether there are any other statements relating to use of ocular decongestants in children that should be included on the package labelling.

Note that if the proposed statement is added to the Label Statements Database, words of a similar meaning to the statement may be used on the package labelling, provided the intent is not changed.

To assist in the analysis of submissions, Medsafe will only accept submissions made through this consultation website. However, the full consultation document is attached below as a PDF, and it can be viewed online, downloaded and/or printed.

What happens next

All comments will be considered. Once the analysis of submissions is complete, the Label Statements Database may be updated. We will publish the outcome on the Outcome of Consultations web page on the Medsafe website.

Audiences

  • Members of the public
  • Health sector
  • Pharmaceutical companies

Interests

  • Therapeutic products
  • Pharmacy
  • Child health