Cold medicines for children under six years old face FDA safety review

7 October 2007

The US Food and Drug Administration has published analysis which suggests there could be risks for children under six years old who take over-the-counter cough and cold medications. An advisory committee is due to review the data on October 18. The FDA could recommend that decongestants and cough medicines are not given to children under two years old and antihistamines to under six year olds, according to the Wall Street Journal.

As many as 54 adverse event reports linked to pediatric use of the drugs have been recorded by the FDA. Up to 800 products could be affected by any action of the agency.

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