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Cough and cold medicines in children

TGA announcement

17 April 2008

Over-the-counter cough and cold medicines should not be used in infants and children less than 2 years of age.

Why are cough and cold medicines a concern for children under 2?

• There have been a number of overseas reports of serious adverse effects among infants and children given non-prescription cough and cold medicines.
• The main cause of concern in the USA with the use of cough and cold medicines in children appears to be misuse, medication error, accidental overdose, accidental exposure and concurrent use of multiple products, rather than consequences from usage in accordance with the directions.
• These events have led to reviews of the safety and efficacy of the use in children of medicines containing any of the following active ingredients:
  • The antihistamines: brompheniramine maleate, chlorpheniramine maleate and diphenhydramine hydrochloride;
  • The antitussives: dextromethorphan hydrobromide and pholcodine;
  • The expectorants: guaifenesin and ipecacuanha; and
  • The decongestants: phenylephrine hydrochloride and pseudoephedrine hydrochloride.
• These reviews indicate that there is a lack of evidence of effectiveness, and when balanced against the risks in the use of these products in children less than 2 years of age, there is no overall health benefit.
• Therefore, the TGA advises that products containing these ingredients should not be administered to children less than 2 years of age.

What action has been taken by the TGA?

• The TGA has already advised the sponsors of cough and cold medicines previously approved in Australia for use in children aged under 2 years to cease labelling of these products for use in that age group.
• The TGA will shortly advise sponsors that labels of all over-the-counter cough and cold medicines sold in Australia must include the advice "Do not use in children under 2 years of age".
• Changes to the labelling of current products may take some time to be fully implemented.

Will some cough and cold medicines need a prescription for use in children under 2 years of age?

• Any medicine containing sedating antihistamines will become 'prescription only' if they continue to include directions for use for children under 2 years of age from 1 September 2008.
• This decision was made by the National Drugs and Poisons Scheduling Committee (NDPSC) and the Record of Reasons is available on the TGA website.
• Some cough and cold medicines contain sedating antihistamines. These medicines will become 'prescription only' if they continue to include directions for use for children under 2 years of age from 1 September 2008.

Will cough and cold medicines still be available over the counter for use in children under 2 years of age?

• The TGA's view is that the total body of scientific evidence does not support the use of any over-the-counter cough and cold medicines in children under 2, and has already advised doctors, pharmacists and caregivers not to administer them to children in this age group.
• Therefore, all over-the-counter 'cough and cold' medicines are currently in the process of removing any directions for use in children under 2 years of age and will specifically label against use in that age group.

What cautions should I take when administering cough and cold medicines to children?

Labelling changes to existing over-the-counter cough and cold medicines may take some time to be implemented. The TGA has issued the following information and advice for parents and other caregivers:

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