Restrictions On The Use Of OTC Cough And Cold Medicines In Children, Australia

Main Category: Flu / Cold / SARS
Also Included In: Pediatrics / Children's Health
Article Date: 15 Apr 2008 - 2:00 PST

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Pharmacists are asked to advise all customers requesting any OTC cough and cold product that these medicines should not be used in infants and children less than 2 years of age.

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 misadventure 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
- The decongestants: phenylephrine hydrochloride and pseudoephedrine hydrochloride

Recent announcements have also been made by the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) that cough and cold medicines should no longer be used to treat children less than 2 years of age.

Several reviews of the evidence indicate that there is a lack of efficacy, and taken together with 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 considers that products containing these ingredients should not be administered to children less than 2 years of age.

The TGA is advising sponsors that the labels of OTC cough and cold medicines sold in Australia should include the advice "Do not use in children under 2 years of age ".

The TGA has 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.

Where labelled for use in older children, these products may continue to be sold for use in children over 2 years of age.

Changes to the labelling of current products may take some time to be fully implemented.

Pharmacists are asked to advise all customers requesting any OTC cough and cold product that these medicines should not be used in infants and children less than 2 years of age.

Pharmaceutical Society of Australia