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Cough and cold drugs ineffective on kids

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Pharmacists are awaiting the findings of the TGA review into the safety and efficacy of cough and cold medicines in children aged two to 12 years following decisions by two overseas regulators to restrict their use.

Last week the UK's medicines regulator said over-the-counter (OTC) cough and cold medicines should no longer be used in children under six.

A review by the Medicines and Healthcare Products Regulatory Agency (MHRA) found "no robust evidence" that the medicines work. The watchdog said the drugs can cause side effects such as allergic reactions, effects on sleep or hallucinations.

"Cough and cold remedies containing certain ingredients should no longer be used in children under six as the balance of benefits and risk has not been shown to be favourable," the agency said.

Cough and cold products for children from six to 12 will continue to be available in pharmacies where advice can be given.

"This is because the risks of side effects is reduced in older children because they weigh more, get fewer colds and can say if the medicine is doing any good," the agency said, adding that further research is required into the effectiveness of these products in older children.

The recommendation follows an announcement by the Canadian Government in December last year that it would require labelling changes to cough and cold medicines, warning against use in children under the age of six.

Australia's regulator, the TGA, said it was "carrying out a review of the available safety and efficacy data for all ingredients used in registered cough and cold medicines in Australia to determine if any changes should be made to their availability and use in children aged two to 12 years".

Last year the TGA recommended that all cough and cold medicines should not be used in children under two.


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