Published: 12 May 2017
Consultations
Outcome of consultation on proposal to change the warning statement on labels of OTC loratadine and desloratadine medicines
About the consultation
The non-sedating antihistamines, loratadine and desloratadine, are currently required to carry the following label statement regarding drowsiness:
‘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’.
Medsafe received an application seeking a change to the Label Statements Database (LSD) entries for loratadine and desloratadine, requesting that this warning should no longer be required. The request was discussed by the Medicines Adverse Reaction Committee (MARC) at the 166th meeting on 29 June 2016, and a recommendation was made to change the warning statement to the following wording:
‘Very rarely, people get drowsy on this medicine. You should make sure you are not affected before doing activities that require full attention’
Medsafe undertook a public consultation during the period 22 September to 11 November 2016 on the proposal to change the label statement sedation warning on OTC loratadine and desloratadine medicines. The consultation asked submitters if the proposed wording for the label statement was appropriate and whether the proposed target date of 1 March 2017 for implementation of the changed warning statement was reasonable.
Medsafe would like to thank those who took the time to prepare a submission and provide helpful comments and suggestions.
Submissions received
Medsafe received four submissions in response to the consultation. The submissions have been reviewed by Medsafe and the MARC. The submissions are published below:
1. Bayer New Zealand Ltd (PDF 4 pages, 47 KB)
2. New Zealand Self Medication Industry Association (PDF 3 pages, 37 KB)
3. Actavis New Zealand Ltd (PDF 2 pages, 312 KB)
4. Anonymous (PDF 3 pages, 302 KB)
Note: Personal information that can identify submitters has been removed (where requested). Commercially sensitive material provided in support of submissions has not been included with the published submissions.
Consultation feedback
Revised label statement warning
Two submitters considered that no warning statement is necessary.
One submitter considered that the warning statement is appropriate, but would like to see it end-user tested to ensure that it is understood.
One submitter proposed an alternative warning statement, as follows:
‘Some people might get drowsy on this medicine. You should make sure you are not affected before doing activities that require full attention, such as driving or operating machinery’.
Common themes that emerged in the consultation feedback include:
- there is a need for harmonisation of the label statement with other countries, particularly Australia
- the proposed statement wording is confusing
- label statement warnings are normally reserved for common or severe adverse effects, yet the sedation warning refers to a very rare adverse effect associated with loratadine and desloratadine.
Medsafe Response
The consultation feedback was presented to the MARC at the 169th Meeting on 9 March 2017. The Committee was asked to provide advice to Medsafe on whether the proposed label statement from the 166th meeting should be revised or removed from the package label. The Committee considered that information to consumers should be transparent, specific and easy to understand. The Committee agreed on the alternative warning statement suggested by one of the submitters, as follows:
‘Some people might get drowsy on this medicine. You should make sure you are not affected before doing activities that require full attention, such as driving or operating machinery’.
Target date for implementation
Three submitters provided feedback on the timeframe for implementation of the proposed change to the label statement.
All three submitters suggested that the timeframe for implementation should take into account the need to run-out existing stock.
One submitter proposed a 12 month implementation date. The submitter noted that the timeframe for implementation should take into account the time needed to update data sheets/consumer medicine information to ensure consistency across labelling and information for prescribers/consumers. The submitter also noted that a different implementation date may be required for packs supplied for dispensing purposes and those supplied for over the counter (OTC) sales.
One submitter, who favoured the removal of the warning statement altogether, noted that the implementation date could be brought forward to 1 January 2017 while allowing the current warning statement to be temporarily retained if desired by the sponsor, as it is more restrictive. The submitter also proposed a final date for removal of the warning statement of 1 January 2020 to allow for run-out of existing stock.
Medsafe Response
Medsafe accepts the need to run-out existing stock and proposes a revised implementation date of 1 July 2018 for the new label statement.
Enquiries
Any enquiries relating to this consultation should be directed via email to: askmedsafe@health.govt.nz.
