TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

Submissions and TGA response: OTC nasal decongestant preparations for topical use: proposed advisory statements for medicines

9 September 2014

The TGA would like to thank the respondents who have submitted written comments or made submissions in response to the consultation: OTC nasal decongestant preparations for topical use: proposed advisory statements for medicines.

Submissions received

A total of 10 submissions were received. Of these, the following six respondents consented to have their submissions published:

How to access a pdf document

TGA response

1. Advisory statement: "Do not use for more than three days at a time unless advised by a doctor or pharmacist."

Summary of issues

The majority (7/10) of the respondents supported the warning statement as proposed. Two other respondents suggested that the duration of use be amended from 3 days to 5 to be consistent with some Australian recommended clinical and pharmacy reference texts. One suggested restricting the use to a few days at a time, contending that this was a more general and accommodating approach than a specific statement. One respondent did not support the 3-day duration of use limit at all.

TGA response

The TGA considers that the proposed statement with the 3-day duration of use for self-medication is appropriate given the following reasons:

  • The 3-day limit is consistently applied to a large extent and is currently on the approved labels of the overwhelming majority of OTC topical nasal decongestants.

    At the time of writing, there are 48 OTC topical nasal decongestants registered in the Australian Register of Therapeutic Goods (ARTG). The majority contains oxymetazoline (77.1%) followed by xylometazoline (12.5%), tramazoline (8.3%) and phenylephrine (2.1%). 81% of the approved labels have a 3-day duration limit.

  • The 3-day limit has been consistently endorsed by the Advisory Committee of Non-prescription Medicines (ACNM) and its predecessor, the Medicines Evaluation Committee (MEC).
  • The 3-day limit is consistent with the labelling requirements of:
    • The US FDA OTC Monograph 1994 for such medicines which requires the following warnings in this regard: "Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor."
    • Health Canada's labelling standard for such medicines which requires the following warnings in this regard: "Do not use for longer than three days. Frequent or prolonged use may cause nasal congestion to recur or worsen."
  • The proposed statement advises a 3-day duration of use for self-medication and that the advice of a pharmacist or doctor may be required for use beyond 3 days. It would be on the discretion of the pharmacist or doctor to advice the consumer whether to continue on for another few days (e.g. total limit of 5 days continual use as stated in Australian clinical reference texts) or provide alternative treatment.
  • The majority of the respondents (7/10) supported the proposed statement.

Outcome

The advisory statement "Do not use for more than three days at a time unless advised by a doctor or pharmacist" is proposed for inclusion on the labelling of all OTC topical nasal decongestants preparations containing methoxamine, naphazoline, oxymetazoline, phenylephrine, tetrahydrozoline, tramazoline, tymazoline and xylometazoline.

2. Advisory statement: "Frequent or prolonged use may cause nasal congestion to recur or worsen."

Summary of issues

The majority of the respondents (9/10) supported the advisory statement as proposed. Another respondent suggested that the proposed statement also include advice against use at a higher than recommended doses which may also cause rebound congestion. One respondent did not support the proposed statement, stating that the duration of use as well as the existing RASML warning statement (referring consumers to a doctor or pharmacist if congestion persists) adequately addressed the issue of rebound congestion which would only occur if not used according to label directions and warnings.

TGA response

The TGA considers that the proposed warning on frequent or prolonged use is necessary due to the following reasons:

  • The Australian Regulatory Guidelines for over-the-counter medicines (ARGOM) Appendix 5 states: "Rebound nasal congestion can occur as a result of continued use of topically administered decongestant nasal products. Such products should contain a statement advising against prolonged use such as 'If congestion persists for more than a few days, seek medical or pharmacist advice'". The RASML requires the statement "If congestion persists, consult your doctor or pharmacist" for topical nasal decongestants. However, the existing statements in ARGOM and RASML do not convey the message about prolonged or frequent use. It only advises consumers to seek advice if congestion still persists.
  • The dosage on the labels is on a 'as necessary' basis. Consumers may, without the advice of a pharmacist or doctor, use the medicine more often as necessary for symptomatic relief or for a prolonged period given that these medicines are for self-medication.
  • The proposal is consistent with the labelling requirements of the US FDA and Health Canada.
  • The majority of the respondents (9/10) supported the proposed statement.

It is noted that some approved labels already include a statement on rebound congestion.

The TGA considers that it is not necessary to include a warning against use at a higher than the recommended doses which may also cause rebound congestion as the labels only include the usual recommended dosage and that all OTC medicines should not be used at higher than recommended doses for self-medication.

Outcome

The advisory statement "Frequent or prolonged use may cause nasal congestion to recur or worsen" is proposed for inclusion on the labelling of OTC topical nasal decongestants preparations containing methoxamine, naphazoline, oxymetazoline, phenylephrine, tetrahydrozoline, tramazoline, tymazoline and xylometazoline.

3. Other issues

Summary of issues

The majority of the respondents queried about the transition period.

One respondent expressed a concern that this consultation process, in which the proposal for inclusion of a warning statement in RASML arose during the development of an OTC medicine monograph, would repeat itself with any new OTC monograph created.

A respondent also queried about acceptance of existing wordings on the labels if already worded to the same effect or stricter.

TGA response

The transition period for this new requirement will be 18 months from the date of publication on the Federal Register of Legislative Instruments (FRLI) of the new RASML update. For those sponsors who are affected, the TGA will allow sponsors to submit a change application (C1) using the change code 'LLO' to include the new proposed RASML warning statements provided that there are no other changes made in that application with the exception of other C1 changes. In cases where sponsors cannot meet the implementation date, the TGA usually considers a reasonable request for an exemption.

During development of the OTC medicine monograph for topical nasal decongestants, the TGA identified statements applied consistently during evaluation of medicine labelling, in terms of safety and efficacy, of such medicine registration applications. Consolidating these requested statements would provide clarity to sponsors and maintain consistency of labelling statements in Australia.

The RASML permits variation of the wording of the warning statements specified in the document provided that the intent is not changed.

Final proposal

The following advisory statements are proposed for the RASML entries for methoxamine, naphazoline, oxymetazoline, phenylephrine, tetrahydrozoline, tramazoline, tymazoline and xylometazoline when supplied as a non-prescription medicine under the conditions stated.

Table 1. Proposed advisory statements for nasal decongestant preparations
Substances Conditions Required advisory statements
  • Nasal decongestant preparations including:
  • Methoxamine
  • Naphazoline
  • Oxymetazoline
  • Phenylephrine
  • Tetrahydrozoline
  • Tramazoline
  • Tymazoline
  • Xylometazoline
When in nasal decongestant preparations for topical use
  • Do not use for more than three days at a time unless advised by a doctor or pharmacist.
  • Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • #If congestion persists, consult your doctor or pharmacist.
Table 2. Proposed advisory statements for methoxamine, naphazoline, tetrahydrozoline, tramazoline and tymazoline
Substances Conditions Required advisory statements
Methoxamine In nasal decongestant preparations for topical use
  • Do not use for more than three days at a time unless advised by a doctor or pharmacist.
  • Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • #If congestion persists, consult your doctor or pharmacist.
Naphazoline
Tetrahydrozoline
Tramazoline
Tymazoline
Table 3. Proposed advisory statements for oxymetazoline, phenylephrine and xylometazoline
Substances Conditions Required advisory statements
Oxymetazoline, phenylephrine and xylometazoline In nasal decongestant preparations for topical use
  • Do not use for more than three days at a time unless advised by a doctor or pharmacist.
  • Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • #If congestion persists, consult your doctor or pharmacist.
In nasal decongestant preparations for topical use indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years
In nasal decongestant preparations for topical use indicated for cough, cold or flu which include dosage instructions for children aged from 'x' to 11 years (where 'x' is 6,7,8,9,10 or 11)

#Existing RASML warning statement.

Note: the RASML Schedule 2 requirements arising from the TGA cough and cold review have not been reproduced in the tables.