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Published: 27 October 2017

Consultations

Outcome of consultation on changes to the Label Statements Database for sedating antihistamines available without a prescription

About the consultation

In August 2017 Medsafe published a consultation on proposed changes to warning statements on labels of sedating antihistamines available without a prescription. The consultation sought feedback on the proposal by 29 September 2017. Medsafe would like to thank everyone who took the time to prepare a submission.

Additional information on this consultation

Submissions received

One submission was received in response to the consultation. This submission has been reviewed by Medsafe and is published below.

General Practitioner (PDF 83 KB, 1 page)

Note: the submission has had personal information removed.

Consultation feedback and Medsafe's response

Question	Feedback	Medsafe's response
Whether the following statement should be added to the Label Statements Database for all sedating antihistamine products (unless other age restrictions apply): For oral use: Do not use in children under 2 years old.	The submission supported this proposed change and commented that GP's were advised not to prescribe medications for this age group at least 5 years ago.	Noted.
Whether the following statement in the Label Statements Database for sedating antihistamines is amended (when appropriate) to: For the treatment of insomnia or anxiety: Consult a doctor if sleeplessness (or anxiety) persists.	The submission supported this proposed change. The submitter considers that the indication for anxiety has never been promoted as appropriate therapy in child mental health.	Noted. Please note that the warning statements required for sedating antihistamines that are used for the treatment of insomnia or anxiety will not change at this time. A submission to the Medicines Classification Committee is currently being prepared and this will be discussed at a future meeting (see 'Outcome' below for further information).
What is a suitable target date for implementation?	The submission did not comment on the target date for implementation.	Medsafe considers an implementation timeframe of 18 months is suitable. Therefore the implementation date will be 1 June 2019. Note that at this time, this implementation date relates only to sedating antihistamines for oral use.

Outcome

For oral use

After careful consideration of this response Medsafe concludes that the label statements database should be updated to change the current sedating antihistamine warning statements relating to oral use to:

This medicine may cause drowsiness.
Be cautious about driving a vehicle or operating machinery within 8 hours of taking this medicine.
Do not use in children under 2 years old.

The above warning statements will be required for all oral dose forms of the following sedating antihistamines available without a prescription (unless a current statement overrides these):

alimemazine
brompheniramine
chlorphenamine
cyclizine
dexchlorpheniramine
doxylamine
ketotifen
meclizine
mepyramine
pheniramine
promethazine.

For the treatment of insomnia or anxiety

The warning statements required for sedating antihistamines available without a prescription that are used for the treatment of insomnia or anxiety will not change at this time. A submission to the Medicines Classification Committee is currently being prepared as the classification statements also require updating. This will be taken to a future meeting in 2018.

The outcome of the Medicines Classification Committee discussion regarding label requirements for sedating antihistamines used for the treatment of insomnia or anxiety will be published in the minutes of the meeting on the Medsafe website later in 2018 (www.medsafe.govt.nz/profs/class/minutes.asp).

Implementation

The change in the warning statement for sedating antihistamines for oral use that are available without a prescription will be required to be placed on labels from 1 June 2019. The Label Statements Database will be updated to this effect.

Note that at this time, this implementation date relates to sedating antihistamines for oral use only (see above for further information on label statement updates for sedating antihistamines that are used for the treatment of insomnia or anxiety).