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

Results updated 16 Nov 2021

Introduction

We asked for comments from interested parties on proposed new advisory statements for labels of over the counter (OTC) medicines containing mometasone in dermal and nasal spray preparations, for inclusion in the Required Advisory Statements for Medicine Labels (RASML).

Summary and discussion of responses

The TGA would like to thank those who responded to the consultation. We received 6 submissions. These were mostly supportive, but most suggested some amendments.

One respondent recommended review of the warning “Unless a doctor has told you to, do not use on areas that rub together”, indicating that it might not be accurate or sufficient with regard to use on “flexures”. While the TGA note that some caution may be required with application to specific areas, the proposed warning is considered sufficient, noting that specific precaution in this regard is not specified in the approved product information, that pharmacist involvement is required for purchase of this S3 medicine and that there are already a large number of warnings required on the potentially small carton label. The warning could be strengthened in a subsequent update if considered necessary.

Three respondents considered the proposed pregnancy warning to be excessive, particularly reference to “Unless a doctor has told you to, do not use if …likely to become pregnant”. Given the risk involved and the large number of warnings proposed, reference to “likely to become pregnant” will be deleted from both dermal and nasal spray entries. While risk in breastfeeding appears to be low, as noted by one respondent, advice to discuss with a doctor or pharmacist is consistent with the product information and considered appropriate.

Two respondents suggested simplifying the warning regarding use on skin infections by deleting the included examples. The TGA consider that some of the examples are required but reference to “chicken pox” (a known but less common infection) and “ringworm” (covered by “tinea”) will be deleted. For consumer clarity, “ulcerous skin” will be simplified to “broken skin” as recommended by one respondent.

Apparent inconsistencies with RASML entries for hydrocortisone and clobetasone were raised by one respondent. These are partly due to differences in corticosteroid potency, but the clobetasone RASML entry may warrant review by the TGA at a later date. It is noted that additional warnings to those specified for clobetasone in RASML are included on existing OTC clobetasone products.

One respondent recommended that warnings regarding use in children and on skin areas that rub together should be removed and that other warnings should be expanded to allow advice from a pharmacist rather than only a doctor. The TGA, however, considers that medical advice is appropriate for use of dermal mometasone in these circumstances.

Two respondents considered the 18-month transition time for implementation to be short. The TGA considers this timeframe to be appropriate and notes that temporary exemptions may be given in extenuating circumstances.

Outcome

Following feedback from the consultation, amendments to the proposed RASML entries are made as shown in the document linked below (see tracked changes). The final entries will be included 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.

Final RASML entries for mometasone

Published responses

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