Important changes to cough and cold medicines for children

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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.

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:

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  • 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.

Source: Department of Health and Ageing 

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Date Created: December 3, 2012