Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Lidocaine (lignocaine)

Results updated 16 Nov 2021

Introduction

We asked for comments from interested parties on the proposal for a new advisory statement, “Do not use for teething pain in children”, for labels of OTC medicines containing more than 1.5 per cent lidocaine (lignocaine) for topical oral use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document.

Summary and discussion of responses

The TGA would like to thank those who responded to the consultation. We received 7 submissions. Responses were generally supportive, but some raised related concerns and suggestions.

Two submissions proposed a more restrictive warning not to use in young children at all, rather than referring only to teething. However, given that lignocaine is not contraindicated in young children in all circumstances, the TGA considers this to be unsuitable.

One submission recommended further actions such as safety announcements and up-scheduling of relevant lidocaine-containing medicines to S3 and considered that further safety review of all teething gels was required. The TGA considers that based on available data, further changes to regulation and labelling of lidocaine-containing products that are used, or could be used, for teething are not required at this time. The TGA continues to monitor the safety of available teething medicines and will assess the need for changes to regulation and labelling in response to further safety issues as necessary.

One submission noted that clarification is necessary on the requirement for the warning to be included for pharmacy-compounded lidocaine products. The TGA does not regulate the labelling of medicines that have been extemporaneously compounded by pharmacists for an individual. Pharmacists must package and label compounded medicines in accordance with the requirements outlined in relevant state and territory legislation, the Poisons Standard and other relevant professional practice standards and guidelines.

Concern was raised regarding safety implications of the 18-month transition period for compliance with new RASML warnings. In this regard, it should be noted that other than a small number of professional use-only (eg dentist) products, all relevant, currently available lidocaine medicines already include the proposed RASML warning.

One submission suggested a minor change to the wording of age restrictions in the existing entries. The TGA notes that the current wording of age restrictions is consistent throughout RASML and considers that the current wording is appropriate.

Outcome

The TGA will include the proposed changes in the next update of the RASML, to occur in late 2021 or early 2022. A transition period of 18 months from commencement of the new RASML will allow for existing medicines that do not comply with new requirements to have their labelling updated.

Published responses

View submitted responses where consent has been given to publish the response.