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Cough and cold medicines for children - changes

26 November 2012

The TGA has conducted a review of the use of cough and cold medicines in children and, as a result, advises consumers and health professionals of the following changes:

• Cough and cold medicines should not be given to children under 6 years of age. A list of the over-the-counter cough and cold medicines available in Australia (as at 6 June 2012) is available on the TGA website.
• Cough and cold medicines should only be given to children aged 6 to 11 years on the advice of a doctor, pharmacist or nurse practitioner.
• From September 2012 new stocks of cough and cold medicines must include warnings and instructions to the above effect and will be in child-resistant packaging.

The TGA has mandated that labels for these products be changed to reflect this new advice, but this will take time to implement. Stock with new labelling began appearing in pharmacies and other retail stores in September 2012. However, existing stock with the older labelling is allowed to be sold for use in adults and children aged 6 years and older until it is exhausted.

It is important to note that, while the TGA has taken the above actions in the interests of children's health, these products have not been rescheduled (a prescription is not required) and their use in children under 6 years of age has not been banned.

Information for consumers

• The TGA's review has found that there are no immediate safety risks with these products. However, there is evidence that they may cause harm to children, while the benefits of using them in children have not been proven.
• Other reasons for the changes include:
• A child under 6 years of age may appear to have a cold but actually be suffering from a more serious illness (for example: influenza, asthma, bronchitis or allergic rhinitis), which may require medical attention and treatment.
• Cough and cold medicines offer only temporary relief of common symptoms, such as runny nose, cough, nasal congestion, fever and aches. They do not affect the severity of the viral infection or shorten the time the infection lasts.
• Overdose of these medicines can lead to serious harm.
• Possible side effects include:
  • allergic reactions
  • increased or uneven heart rate
  • slow and shallow breathing
  • drowsiness or sleeplessness
  • confusion or hallucinations
  • convulsions
  • nausea
  • constipation.

As for all medicines, it is important to read and follow the instructions on the label of cough and cold medicines. However, if you have or purchase cough and cold medicines with the out-dated labelling, the TGA advises that you do not give them to children under 6 years of age. If you have any questions, or doubts about whether your child has a common cold or something more serious, consult a health professional.

Please note that, while the TGA feels that its safety concerns warrant the above changes, these products have not been banned.

Alternative treatments for coughs and colds in children aged less than 6 years include:

• rest
• drink plenty of water and non-alcoholic fluids
• inhale steam (under adult supervision) to help relieve a blocked nose­-a shower in a closed room is an effective method
• analgesics, such as paracetamol and ibuprofen, can be used to help reduce pain and fever
• saline nose drops can be used to help relieve a blocked nose
• avoid exposure to cigarette smoke.

More information about colds and medicines and treatments for coughs and colds is available from the NPS MedicineWise website.

Information for health professionals

Health professionals are advised of the following:

• No changes have been made to the scheduling of over-the-counter (OTC) cough and cold medicines and a prescription is not required. However, a recommendation for treatment with these medicines in a child under 6 years of age constitutes off-label use.
• Recommendation for treatment with a cough and cold medicine in a child aged less than 6 years constitutes off-label use and should not be made without serious consideration of the risks and benefits. There is no robust evidence of efficacy for these medicines in children and there are a number of safety concerns.
• While the safety concerns are lower in children aged 6 - 11 years than in children aged less than 6 years, they should be taken into consideration when advising parents on the management of coughs and colds.
• The new labels will provide no dosing information for children aged less than 6 years and, in some cases, for children aged less than 12 years.
• If you have cough and cold medicine with the old labelling in stock, do not supply for use in children aged less than 6 years and only supply for use in children aged 6 to 11 years after advising parents of the warnings for use in this age group.
• The use of the individual medicines for indications other than cough and cold (for example: for pain or allergies) is not affected by this review.
• The TGA has received queries from pharmacists who have had patients present a doctor's prescription or note for an OTC cough and cold medicine for a child aged less than 6 years. If you have concerns in regard to use or dispensing please contact your professional body.
• Specific information, advice and resources for pharmacists can be found at the following websites:
  • The Pharmacy Guild of Australia
  • Pharmaceutical Society of Australia

More information for your patients about colds is available from the NPS MedicineWise website.

Further information

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 below for the treatment of symptoms of coughs and cold in children aged less than 12 years.

The TGA's review has found that there are no immediate safety risks with these products. However, there is evidence that they may cause harm to children, while the benefits of using them in children have not been proven.

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 6-11 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.

Similar independent reviews have also been undertaken in the UK, the USA, Canada and New Zealand. Their conclusions about the lack of efficacy and the potential risks of these medicines in children were essentially the same as those reached by the TGA.

Cough and cold medicines used for treating children that contain at least one of the below active ingredients are affected by the changes.

Individual medicines

Type of medicine	Active ingredients
antihistamines	brompheniramine chlorpheniramine dexchlorpheniramine diphenhydramine doxylamine pheniramine promethazine triprolidine
antitussives	codeine dextromethorphan dihydrocodeine pentoxyverine pholcodine
mucolytics/expectorants	bromhexine guaiphenesin ipecacuanha senega and ammonia
decongestants	phenylephrine pseudoephedrine oxymetazoline xylometazoline

A list of the over-the-counter cough and cold medicines available in Australia (as at 6 June 2012) that contain one or more of the active ingredients in the table above is available.

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