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OTC cough and cold medicines for children - Final outcomes of TGA review

15 August 2012

Issue

The Therapeutic Goods Administration (TGA) has carried out a review of the safety and efficacy of registered over-the-counter (OTC) cough and cold medicines for children aged 2-12 years.

The medicines reviewed contain one or more of the following active ingredients:

Type of medicine reviewed and the active ingredients
Antihistamines: Brompheniramine, Chlorpheniramine, Dexchlorpheniramine, Diphenhydramine, Doxylamine, Pheniramine, Promethazine, Triprolidine
Antitussives: Codeine, Dextromethorphan, Dihydrocodeine, Pentoxyverine, Pholcodine
Expectorants/Mucolytics: Ammonium chloride, Bromhexine, Guaifenesin, Ipecacuanha, Senega and Ammonia
Decongestants: Oxymetazoline, Phenylephrine, Pseudoephedrine, Xylometazoline

Final conclusions and actions

As a result of this review, the TGA has concluded that there are no immediate safety risks with cough and cold medicines. However, the review has found that there are potential risks associated with these products for children and only limited benefits. On this basis:

  • Children under 6 should not be given medicines to treat cough and cold symptoms.
  • Children aged 6-11 should only be given medicines to treat cough and cold symptoms on the advice of a doctor, pharmacist or nurse practitioner.
  • If a cough and cold medicine is indicated for children aged between 6 and 11 years, the correct dosage should be included on the label to avoid guesswork.
  • Cough and cold medicines should be in child-resistant packaging.
  • Particular efforts should be made to inform consumers and health professionals that children under 6 should not be given cough and cold medicines.
  • There is no need to change the scheduling1 of these medicines or their availability through pharmacies or other retail stores.

In many cases, cough and cold medicines available in the Australian marketplace are already labelled and packaged in accordance with these conclusions.

Where this is not the case, the TGA has instructed sponsors to amend their labelling (and any other written information about the product) and packaging in line with these conclusions from 1 September 2012 so that stock with the revised labelling and packaging will be available in the Australian market for the winter season of 2013.

In light of the evidence that these products do not pose an immediate safety risk for children, sponsors have been allowed some flexibility in how these products are presented. Many products will carry a warning that they are not to be used in children aged under 6 years and should only be used in children aged 6 to 11 years on the advice of a doctor, pharmacist or nurse practitioner. Some may indicate that they should not be used in children under an age greater than 6 years (e.g. 8 years), and some products may, instead, indicate that they are not to be used in children aged less than 12 years.

For a period, product with the current labelling and the new labelling will be available. This is because batches of product partly or completely released into the Australian marketplace prior to 1 September 2012 will be allowed to be marketed through to the end of their shelf lives for older children (aged 6 years and older) and adults, but they should not be used to treat children under 6 years of age.

To ensure that the outcomes of this review are applied to cough and cold medicines registered in the future, appropriate changes will also be made to the following:

A list of OTC cough and cold medicines available in Australia is available for information.

The TGA has also published new advice for parents and caregivers on coughs and colds.

  1. 1 The "scheduling" of a medicine refers to the level of restrictions on its availability and sale as set out in the different Schedules in the Standard for Scheduling of Medicines and Poisons (SUSMP). "Unscheduled" medicines may be sold in pharmacies or other retail store, "Pharmacy Only" (Schedule 2) medicines are available only in pharmacies, "Pharmacist Only" (Schedule 3) medicines may only be sold to a customer by a pharmacist, and "Prescription Only" (Schedule 4) medicines are only available from a pharmacist on prescription.

Background

In 2009 the TGA carried out a comprehensive review of the available data in the medical literature and TGA records relating to the safety and efficacy of OTC cough and cold medicines containing one or more of the active ingredients listed above for the treatment of symptoms of coughs and cold in children aged less than 12 years.

The conclusions reached were that there is currently a lack of evidence of efficacy for OTC cough and cold medicines in children aged under 12 years of age and the historical profile of adverse reactions indicates that there are potential risks involved in use of these medicines in these children. The risks are greater in children aged less than 6 years than between 6 and 11 years. Therefore, these medicines should not be used for the treatment of children under 6 years of age, and they should only be administered to children aged 6-12 years on the advice of a doctor or pharmacist, and all these medicines should be labelled accordingly and should be in child-resistant packaging. The scheduling of these medicines should also be considered to determine if any changes are needed to their availability.

Public consultation

The details of the review and its initial conclusions and recommendations were published on the TGA's web site in October to December 2009 and stakeholders and the public were invited to make submissions for consideration before final decisions were reached.

The consultation closed on 18 December 2009, but the information published may be downloaded from Labelling and packaging of cough and cold medicines - proposed changes to requirements.

Public submissions received

Seventeen submissions were received from the medical and pharmacy professions, the pharmaceutical industry and the National Prescribing Service, and were considered by the TGA. The submissions not marked confidential are available below.

The medical profession

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The pharmacy profession

The pharmaceutical industry

Other

Summary of submissions received

The submissions from the medical profession concurred with the conclusions of the TGA and its advisory committee, the Medicines Evaluation Committee (MEC) now known as the Advisory Committee on Non-prescription Medicines (ACNM) about the lack of proven efficacy and the potential risks associated with these medicines for the treatment of children. The AMA expressed particular concern that inappropriate use of OTC medicines may delay diagnosis and treatment of more serious conditions. The medical professional submissions did not consider that the lack of efficacy and potential risk applies to oxymetazoline and xylometazoline nasal drops and oral dextromethorphan. Two of these submissions expressed support for up-scheduling of OTC cough and cold medicines for children.

The submissions from the pharmacy profession acknowledged the lack of efficacy data but contended that lack of efficacy data does not equate to evidence of lack of efficacy. The pharmacy profession submitted that available data do not support safety concerns within the Australian context, and that that the available evidence does not support the proposed restrictions. In particular, the PSA recommended that the TGA consider separate recommendations for bromhexine and nasal decongestants. There was no support from the pharmacy profession for up-scheduling of OTC cough and cold medicines for children.

The submissions from the pharmaceutical industry were generally accepting of the current lack of robust evidence of efficacy and the potential for harm from the use of these medicines in the treatment of children. There was also acceptance of the need for these medicines to be labelled with a warning that they should not be used in children aged under 6 years. A confidential submission contended that single-active bromhexine products are safe (even at overdose) in children aged 2-12 years and that they do have established efficacy as a mucolytic. This submission therefore strongly opposed the proposal to contraindicate bromhexine single-active cough and cold medicines for children aged 2-5 years and any up-scheduling of these products for children aged 6-12. The pharmaceutical industry opposed any up-scheduling of OTC cough and cold medicines.

The NPS submission was in agreement with the TGA's conclusions about the lack of proven efficacy of OTC cough and cold medicines and the potential risks associated with their use in children under the age of 12 years. The NPS supported referring the matter of scheduling of these medicines to the National Drugs and Poisons Schedule Committee (NDPSC) now known as the Advisory Committee on Medicines Scheduling (ACMS).

There was general support and little opposition from the medical and pharmacy professions and the pharmaceutical industry for the proposal to require oral cough and cold medicines to be in child-resistant packaging. A similar requirement for nasal drops and sprays was not generally supported, but these products are already in small containers that are exempt under Section 7 of Therapeutic Goods Order No. 80 (TGO 80).

There was wide support and no opposition from the medical and pharmacy professions, the pharmaceutical industry and the NPS for a public awareness and education campaign to accompany the introduction of the changes to labelling of these medicines.

The TGA originally proposed that the changes to labelling and packaging become effective from 1 July 2010. Several submissions advocated delaying the changes to 2011 and making all of the changes to labelling, packaging and scheduling (if any) together. Some submissions also urged the TGA to harmonise its labelling requirements with those adopted by Medsafe in New Zealand.

TGA response to the submissions received

Medicines should only be administered to children (and especially very young children) if they are supported by adequate evidence of both safety and efficacy for the intended indication in children. While the safety risks may differ depending on the medicines concerned, if there is inadequate evidence of efficacy and, at the same time, any risk of harm, then the risk-benefit balance is unfavourable.

The use of cough and cold medicines in children also presents a risk of more serious illnesses being diagnosed later than necessary. Some of the symptoms of coughs and colds are similar to, and can easily be confused with, those of other illnesses (e.g. influenza, asthma, bronchitis or allergic rhinitis) that require early medical intervention. It is important that a proper determination is made of a child's illness before any treatment is administered.

Nasal decongestants may be less hazardous in themselves than some of the oral medicines, but they still present a safety risk and they also carry associated risks of serious physical injury to a small child's delicate nasal passages during insertion and use of droppers and spray nozzles.

There is also a need for consistency in the labelling of cough and cold medicines to reduce the potential for confusion and to promote appropriate use of these medicines.

The TGA has considered the submissions received and has concluded that there are insufficient grounds to change its overall conclusions about the safety and efficacy of any of these medicines for the treatment of children. However, the TGA has:

  • refined its recommendations regarding labelling to allow more flexibility in light of the submissions received
  • delayed introduction of the changes until late 2012 in readiness for the winter of 2013
  • made appropriate provision for clearance of stock with the current labelling and packaging in the marketplace at the time the changes come into effect.

The TGA has also sought and followed the advice from the Advisory Committee on Medicines Scheduling on the scheduling of these medicines and the advice of the Therapeutic Goods Committee on their packaging.

Consequently:

International reviews

Similar reviews on OTC cough and cold medicines for children have also been conducted by regulatory authorities in:

The conclusions reached by the TGA are similar to those of other regulatory agencies: these medicines pose a risk to children and they have not been clearly demonstrated to be useful in treating the symptoms of coughs and colds in children.

Each regulatory agency has considered the situation in its own country. As the health system in each country is different, the regulatory decisions made by the different agencies differ slightly regarding the labelling of these medicines.