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Changes to the use of Cough and Cold medicines in children

From 1 September 2012, there are changes in the use of cough and cold medicines in children. These changes have come about following a review by the Therapeutic Goods Administration (TGA) into their safe use following overseas reports of misuse and harm. Similar changes are in place in countries such as the USA, UK, Canada and New Zealand.

While the TGA did not identify any immediate safety risks, the review found that there were potential risks associated with using cough and cold medicines in children with limited benefits. These risks included potential side-effects such as allergic reactions, drowsiness or sleeplessness, nausea, constipation, slow and shallow breathing, increased or uneven heart rate, confusion, hallucinations or convulsions. While these risks may be rare, the risk is greater in children under 6 or with overuse or overdose of cough and cold medicines.

Summary of Changes

As a result of its review, the TGA advises that:

cough and cold medicines should not be given to children under 6 years of age
cough and cold medicines should only be given to children aged 6 to 11 years on the advice of a pharmacist or prescriber
cough and cold medicines should be packaged in child-resistant containers

The packaging and labelling for cough and cold medicines will change to reflect this new advice. As there is no change in the formulation or access to these medicines and there is no immediate risks identified, there is no requirement to return cough and cold medicines being used by consumers or already on pharmacy shelves.

While some cough and cold medicines have already changed their labelling and packaging, the rest will now follow. For a while, cough and cold medicines with the new labelling and packaging will be seen in pharmacies along with any existing stock with the old labelling and packaging. It is expected that by the 2013 winter season, mostly products with the new labelling and packaging will be available.

Detailed information about the changes is available HERE

Affected Medicines

The cough and cold products affected include a range of medicines used for symptoms such as nasal congestion, chesty coughs and dry coughs. The TGA has prepared a list of affected cough and cold medicines available in Australia as of 6 June 2012. To check if a particular product is affected, click HERE

What can you do for children with coughs and colds?

Always read and follow the instructions on any medicine label
NEVER guess a dose for younger age groups
Do not use cough and cold medicines in children under 6 years of age
Check with your pharmacist or prescriber before using cough and cold medicines in children aged from 6-11 years
If you are concerned that your child has something serious, consult a doctor
Other products such as paracetamol, ibuprofen, saline sprays, or vapourisers may be useful for some cold symptoms – ask your pharmacist for advice

Remember! If in doubt – Ask your pharmacist!

Other useful websites for information about coughs and colds in children include: