Published: 22 September 2016
Consultations
Change to warning statements on labels of OTC loratadine and desloratadine medicines
Closing date: 11 November 2016
Invitation to Comment
Timetable
Background
Proposal
Next steps
How to respond
What will happen
Confidentiality
Enquiries
This consultation is intended to:
- propose changes to the labelling requirements for over-the-counter (OTC) medicines containing loratadine or desloratadine
- provide a contact point for queries or feedback on the proposed changes.
Invitation to comment
Medsafe is seeking comments and input from interested parties on the proposed changes to the labelling requirements for OTC medicines containing loratadine or desloratadine.
Timetable
Document released for consultation on 22 September 2016. Interested parties should respond by close of business Friday 11 November 2016. Feedback will be released following consideration of submissions.
Background
Loratadine and desloratadine are members of the class of non-sedating antihistamines. Warning statements are mandated for these medicines as provided by regulation 13(1)(i) of the Medicines Regulations 1984, including the following 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.
An application was received by Medsafe seeking a change to the Label Statements Database (LSD) entries for loratadine and desloratadine, requesting that this warning should no longer be required. At the 166th Medicines Adverse Reaction Committee (MARC), on 29 June 2016, a recommendation was made that the current warning statement should be amended to reflect the low but potential risk of sedation, and to remove reference to the risk of driving impairment. The MARC meeting minutes are available on the Medsafe website.
Proposal
It is proposed to amend the required warning statement to:
- Very rarely, people get drowsy on this medicine. You should make sure you are not affected before doing activities that require full attention.
Medsafe proposes an implementation date for the changes described above of 1 March 2017. As the proposed warning statement is less restrictive than the current statement, sponsors will be able to continue to use the current statement if they wish. Any changes to labelling to comply with the proposed statement will be at the sponsors discretion following the implementation date.
Medsafe has reviewed warnings required in other jurisdictions and considers that the proposed warning statements are consistent with the pharmaceutical industry's desire to harmonise labelling whenever possible.
Next steps
Comments are sought on the proposed amendment to the warning statement to be placed on the labels of OTC medicines containing loratadine and desloratadine. Submissions may address the statement, or the target date for implementation.
How to respond
Please complete the Medsafe consultation submission form:
OTC loratadine
and desloratadine label statements consultation submission form
(Adobe pdf document, 3 pages, 28 KB)
OTC loratadine
and desloratadine label statements consultation submission form
(Microsoft Word document, 3 pages 44 KB)
Submissions must include full personal or organisational contact details (including address, telephone number or email address).
Electronic submissions are preferred and should be emailed to medsafeapplications@health.govt.nz, and include 'Loratadine warning statements' in the subject line of the email.
Alternatively, hard copy submissions may be posted to:
Product Regulation
Medsafe
PO Box 5013
Wellington 6140
What will happen
Submissions will be reviewed by Medsafe and feedback on submissions will be provided through the Medsafe website. Input from submitters on the consultation draft will help inform the wording of the warning statement for OTC medicines containing loratadine or desloratadine.
Confidentiality
All submissions may be placed on the Medsafe website unless marked confidential. Any confidential material contained within your submission should be clearly marked 'IN CONFIDENCE'. Reasons for a claim of confidentiality must be included in the space provided on the submission coversheet. These reasons must meet Official Information Act 1982 requirements if the submission (or part thereof) is not to be displayed. The Official Information Act criteria is available here.
For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the Medsafe website. In addition, a list of parties making submissions may be published.
If you do not wish to be identified with your submission, or if you do not wish your submission to be associated with a party, you must specifically request this in the space provided on the submission coversheet.
Enquiries
Any questions relating to submissions should be directed by email to medsafeapplications@health.govt.nz
