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FDA urged to tighten up on paediatric cold remedies


Cold medicines that parents in the USA give to their children do not work and should not be used by youngsters under the age of six, it has been claimed.

Health advisers told the FDA they believed more research needed to be carried out into the over-the-counter medicines even though billions of doses are currently given to youngsters every year.

University of Pennsylvania epidemiologist Dr Sean Hennessy said: “The data that we have now is they don’t seem to work.”

The recommendation applies to medicines containing one or more of the following ingredients: decongestants, expectorants, antihistamines and antitussives.

The nonbinding recommendation is likely to lead to a shake-up in how the medicines are labelled, marketed and used.

In two separate votes, the panellists said the medicines should not be used by children under the age of two or those under the age of six.

Earlier, the panellists voted unanimously to recommend that more research be carried out on the medicines to determine whether they work.

That would require the FDA to institute a rule-making process to reclassify the medicines, since the ingredients included are now generally recognised as safe and effective.

That process could take years, but FDA officials said the issue could be resolved sooner if the medicines are simply relabelled to state that they should not be used in some age groups.

Copyright Ā© PA Business 2007

University of Pennsylvania Center for Clinical Epidemiology and Biostatistics

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