Revised: 24 August 2015

Consultations

Outcome of consultation on the proposed addition of warning statements on labels of OTC oral and topical diclofenac medicines

About the consultation

In May 2015, Medsafe published a proposal for the addition of warning statements on the labels of OTC oral and topical diclofenac medicines, and sought feedback on the proposal by 22 June 2015. Medsafe would like to thank those who took the time to prepare a submission and provide helpful comments and suggestions.

Submissions received

Medsafe received two submissions in response to the consultation. The submissions have been reviewed by Medsafe. The submissions are published below.

New Zealand Self Medication Industry (PDF 267 KB, 2 pages)

Novartis Consumer Health Australasia (PDF 78 KB, 2 pages)

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.

The consultation asked submitters if the proposed warning statements were appropriate, whether there were other warning statements that should be added, and whether the proposed target date of 12 December 2015 for implementation of the additional warning statements was reasonable.

Consultation feedback

Oral diclofenac warning statements

The submitters were in favour of including the additional warnings on the labels of OTC oral diclofenac medicines. However, one submitter proposed adopting the exact wording of the Australian Therapeutic Good Administration’s (TGA) label advisory statements for a harmonised approach, while another submitter voiced a concern that Medsafe’s proposed wording might not be considered by the TGA to be equivalent to their statements.

One submitter wondered if Medsafe would be updating the label statements for other non-steroidal anti-inflammatory drugs (NSAIDs) besides diclofenac. There was also a suggestion for consistent warning statements where required, across all OTC oral non-steroidal anti-inflammatory drugs (NSAIDS).

Response

Medsafe appreciates the submitters’ support for the proposal to include additional warning statements on the labels of oral OTC diclofenac medicines. After reviewing submitters’ comments, Medsafe has made some changes to the proposed statements where appropriate. Medsafe believes the wording of the proposed statements make it easier for consumers to understand the issue at the root of a particular statement. In arriving at this conclusion, Medsafe has also considered that New Zealand has various groups of healthcare professionals (ie, designated prescribers) besides doctors and pharmacists who are allowed to prescribe within their scope of practice, and who could be consulted by consumers. Therefore Medsafe has replaced the words “doctor” or “doctor and/or pharmacist” where they occur in the statements with “healthcare professional”. Other label advisory statements in the Label Statements Database with this wording will be changed when those statements come up for review.

Medsafe has considered the request to adopt the TGA’s exact wording for advisory statements. Medsafe’s Label Statements Database allows the use of words of a similar meaning, provided the intent of the message is not lost. Statements using the wording required by the TGA for the advisory statements for oral diclofenac medicines in Australia would meet this intent.

The required warning and advisory statements for OTC oral diclofenac medicines are:

• do not use if you are allergic to [name of active substance]
• do not use if you are allergic to [other] anti-inflammatory medicines
• if you get an allergic reaction stop taking and see your healthcare professional immediately
• unless a healthcare professional has told you to, do not use [this product/insert name of product] with other medicines containing diclofenac, aspirin or other anti-inflammatory medicines or other medicines that you are taking regularly
• do not use if you have asthma except on the advice of a healthcare professional
• do not use for more than a few days at a time except on the advice of a healthcare professional
• do not use [this product/insert name of product] 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 take more than the maximum stated dose
• do not use if you have kidney problems
• do not use if you have heart problems
• long term use can be harmful and increases the risk of heart attack, stroke or liver damage.

Words of a similar meaning may be used and individual statements may be combined provided their intent is not changed.

Topical diclofenac warning statements

One submitter stated that the TGA had not proposed any additional warnings for topical diclofenac. Another submitter strongly opposed the addition of a cardiovascular warning, while the third submitter supported the addition of the proposed warnings except for the warning statement “Diclofenac can get into the blood and may affect the heart or increase the risk of a stroke.”

Response

The submitters provided studies with their submissions showing low levels of systemic absorption from topical diclofenac, and a lack of evidence of serious systemic effects. The information has been reviewed. The studies indicated a very low level of systemic absorption from topically applied diclofenac when compared to orally administered diclofenac. Medsafe considers that the submitters have made a valid case for not requiring advisory statements about cardiovascular risk or systemic adverse events. As there is a low risk of systemic adverse events from topical diclofenac, Medsafe also considers that a statement limiting the duration of use to 14 days, as proposed, is not necessary.

The required warning and advisory statements for OTC topical diclofenac medicines are:

• do not use if you are allergic to [name of active substance]
• do not use if you are allergic to [other] anti-inflammatory medicines
• if you get an allergic reaction stop taking and see your healthcare professional immediately.

(Words of a similar meaning may be used and individual statements may be combined provided their intent is not changed.)

Proposed implementation date

Submitters pointed out that the TGA has now decided on an implementation date of 1 July 2016 for OTC oral diclofenac statements to be placed on labels of medicines sold in Australia. Submitters suggested this same date for implementation of required statements for New Zealand.

Response

Medsafe agrees with the submitters’ suggestions, and will make the implementation date 1 July 2016 for the OTC oral and topical diclofenac label advisory statements.

Implementation

The label advisory statements for OTC oral and topical diclofenac medicines will be required to be placed on labels from 1 July 2016. The Label Statements Database will be updated to this effect.

Enquiries

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