Published: 20 July 2017

Consultations

Proposed change to warning statements on labels of oral non-steroidal anti-inflammatory drugs (NSAIDs) available without a prescription

Closing date: 15 September 2017

The Medicines Adverse Reactions Committee (MARC) recently discussed the risk of spontaneous abortion in pregnant women taking non-steroidal anti-inflammatory drugs (NSAIDs). The Committee recommended that Medsafe update the Label Statements Database to amend the warning statements regarding use in pregnancy for oral medicines containing NSAIDs available without a prescription.

The purpose of this consultation is to seek comments on the proposed changes to warning statements regarding use in pregnancy for oral medicines containing NSAIDs available without a prescription.

About the consultation

Medsafe is seeking comments on the proposed changes to warning statements regarding use in pregnancy for oral medicines containing NSAIDs available without a prescription. The proposed warning statements are the same as those required by the Therapeutic Goods Administration in Australia (see Background section).

Table 1 summarises the current and proposed warning statements regarding use in pregnancy and relevant products. The main changes are highlighted in bold text.

Table 1: Current and proposed warning statements on use in pregnancy and relevant products

	Current	Proposed
Warning statements on use in pregnancy	Do not use [product name] during the first 6 months of pregnancy, except on the advice of a healthcare professional. Do not use at all during the last 3 months of pregnancy.	Do not use [product name] if trying to become pregnant, or during the first 6 months of pregnancy except on your doctor's advice. Do not use at all during the last 3 months of pregnancy.
Products	ibuprofen sold as a general sale, pharmacy-only or pharmacist-only medicine in a solid oral dose form. diclofenac sold as an over-the-counter medicine for oral use.	All oral dose forms (solid and liquid) of the following NSAIDs available without a prescription for all indications and all age groups: ibuprofen diclofenac naproxen mefenamic acid flurbiprofen benzydamine.

Invitation to comment

Medsafe is seeking comments and input from interested parties on:

• the proposed changes to warning statements regarding use in pregnancy
• the proposed medicines (oral NSAIDs available without a prescription) that these warning statements should apply to
• a suitable target date for implementation.

Background

The Medicines Adverse Reactions Committee discussed the risk of spontaneous abortion (miscarriage) with the use of NSAIDs at their 170^th meeting. The Committee examined the studies conducted to investigate this risk. The Committee considered the strength of the current evidence to be equivocal for an association between NSAIDs and spontaneous abortion. However, given the seriousness of this potential risk the Committee considered that a woman who is trying to get pregnant should be informed.

Detailed information on the Committee's discussion is available in the minutes of the 170^th meeting and in the report presented to the Committee.

Minutes of the Committee's 170th meeting

Report presented to the Committee (Adobe PDF 892 KB, 28 pages)

The Therapeutic Goods Administration (TGA) in Australia recently consulted on required warning statements for all oral non-aspirin NSAIDs (ibuprofen, diclofenac, naproxen, mefenamic acid, ketoprofen and flurbiprofen) purchased over-the-counter even if they are for children under 12 years of age or specifically indicated for period pain. Acceptance of this proposal would result in harmonised package labelling for New Zealand and Australia. This may be desirable for both consumers and industry to reduce confusion. Further information on the TGA's consultation is available on their website.

TGA's consultation - Submissions and TGA response

Timetable

Document released for consultation on 20 July 2017.

Interested parties should respond by close of business 15 September 2017.

Feedback will be released following consideration of submissions.

How to respond

Please complete the Medsafe consultation form. Submissions must include full personal or organisation contact details (including address, telephone number or email address).

Consultation submission form (Adobe PDF 84 KB, 3 pages)

Consultation submission form (Word Document 46 KB, 3 pages)

Electronic submissions are preferred and should be emailed to medsafeapplications@health.govt.nz including 'NSAIDs 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

Next steps

Submissions will be reviewed by Medsafe and feedback will be provided on the Medsafe website. Input into this consultation will be used to help inform the proposed changes for label statements regarding use in pregnancy for oral NSAIDs available without a prescription.

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.

Official Information Act criteria

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 this consultation should be directed via email to: medsafeapplications@health.govt.nz