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Consultations

Published: 27 March 2014

Outcome of consultation on the planned removal of warning statements from the Label Statements Database for loratadine and cetirizine

About the consultation

In December 2013, Medsafe published a proposal regarding the removal of a labelling requirement for loratadine and cetirizine products on the Medsafe website, and sought feedback on the proposal by 3 March 2014.

Consultation

Medsafe proposed that the warning statement “consult a healthcare professional before use if you have kidney problems or impaired renal function” would be removed from the Label Statements Database if no valid objections were received.

The amendment for loratadine and cetirizine products was proposed due to a lack of clinical evidence to support this warning statement. Additionally, the change would harmonise with Australia where the current requirements for general sale loratadine and cetirizine do not require a warning statement for patients with kidney problems or impaired renal function.

Consultation feedback

One submission was received, which expressed support for the proposed change and suggested that further steps be taken towards harmonisation between Australia and New Zealand.

The submission raised the following issues for consideration by Medsafe:

  1. A further change should be made to remove the warning statement “potential risk of sedation”

The submission stated that some non-sedating antihistamines including loratadine, desloratadine and fexofenadine are required within New Zealand to have a potential risk of sedation warning statement (“Although this medicine is unlikely to affect your ability to drive or operate machinery, a few people may be impaired and care should be taken”), which is not a requirement in Australia. It was proposed that Medsafe make a further harmonisation step to align the requirement of these warning statements between New Zealand and Australia.

Medsafe is not considering this change to the Label Statements Database regarding non-sedating antihistamines at this stage.

Implementation

The warning statement “consult a healthcare professional before use if you have kidney problems or impaired renal function” will no longer be a labelling requirement for loratadine and cetirizine. No products are affected by this more permissive regime; therefore the change will be effective immediately once the Label Statements Database has been updated. Sponsors can still add this warning statement if they choose, but the warning statement is no longer mandatory.

Enquiries

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

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