Don't give young kids cough syrup without doctor's OK: FDA
Health Canada concurs that children under 2 should not take the drugs, pending review
Last Updated: Thursday, August 16, 2007 | 12:22 PM ET
The Canadian Press
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The U.S. government is warning parents not to give cough and cold medicines to children under two without a doctor's order after reports of adverse reactions.
The U.S. Food and Drug Administration has issued a public health advisory, citing serious adverse effects linked to children — particularly those age two and younger —who have received too large a dose of over-the-counter medications.
The FDA says only products earmarked for use by babies, infants or children (sometimes called 'pediatric' use) should be dispensed to those two and under.
(CBC)
It is currently reviewing the products' safety and effectiveness for youngsters.
It says parents should carefully follow directions that come with the medication.
Among its recommendations, the FDA says only products earmarked for use by babies, infants or children — sometimes called "pediatric" use — should be dispensed to those two and under.
Other recommendations include:
- Do not use cough and cold products in children under two unless given specific directions to do so by a health-care provider.
- Cough and cold medicines come in different strengths. If unsure about the right product for a child, ask a health-care provider.
- If other medicines, whether over-the-counter or prescription, are being given to a child, the child's health-care provider should review and approve their combined use.
- Read all of the information in the "Drug Facts" box on the package label to know the active ingredients and the warnings.
- For liquid products, parents should use the measuring device that is packaged with each medicine formulation and is marked to deliver the recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device.
Health Canada said Friday that it is currently assessing the use of cough and cold medication for children younger than two years old and is planning to release guidelines.
Some cough and cold remedies sold in Canada currently include label directions not to use in children under two years of age, Renée Bergeron, a Health Canada spokeswoman, told CBC.ca.
Pending the outcome of Health Canada's assessment of the safety of these products in younger children, this warning may be extended to include all cough and cold products, she said.
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The FDA says only products earmarked for use by babies, infants or children (sometimes called 'pediatric' use) should be dispensed to those two and under.
