Published: 16 December 2013

Consultations

Removal of warning statements from Label Statements Database for loratadine and cetirizine

To:
Product sponsors
Applicants for new and changed medicines
Regulatory affairs consultants

This letter is to:

• signal changes to the labelling requirements for loratadine and cetirizine
• provide a contact point for queries or feedback on the proposed changes.

Background

Loratadine and cetirizine 10 mg tablets in packs containing no more than 5 days supply were reclassified from pharmacy-only medicine to general sale medicine following the 46th Medicines Classification Committee meeting on 15 November 2011. The Committee considered the reclassification of cetirizine hydrochloride 10 mg tablets and loratadine 10 mg tablets together.

The warning statement “consult a healthcare professional before use if you have kidney problems or impaired renal function” was proposed in the application for reclassification. Following reclassification, this warning statement was included in the Label Statements Database.
However, it has been brought to Medsafe’s attention that there is no clinical evidence to support this warning statement. Additionally, the current Australian requirements for general sale loratadine and cetirizine do not require a warning statement for patients with kidney problems or impaired renal function.
 
Medsafe will amend the Label Statements Database to remove this statement required for loratadine and cetirizine unless any valid objections are received. The removal of the statement from the Label Statements Database would not mean sponsors cannot add this warning to labels if they choose, it would just mean that the warning is not mandatory.

Next steps

The target implementation date for the changes described above is 3 March 2014.
 
Queries about, or comments on, the proposed changes described above should be sent to:
 
Laurence Holding
Medsafe
PO Box 5013
WELLINGTON
 
Email: askmedsafe@health.govt.nz
 
by Monday 3 March 2014.
 
Comment on the feedback received and any resulting adjustments to the new requirements will be provided through the Medsafe website (www.medsafe.govt.nz).
 
Yours sincerely
 
Sarah Reader
Manager Product Regulation