FDA strongly recommends OTC cold medicines not be used in children under 2
Agency considering extending advisory to children under 6
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- Infant Overdose from Cough and Cold Drug Toxicity
On January 17, 2008, the United States Food and Drug Administration (FDA) strongly recommended that over-the-counter children?s cold medicines should not be used in children under 2 years of age.
The recommendation comes three months after major drug manufacturers voluntarily withdrew infant cough medicines. After the withdrawals, an FDA advisory panel voted that all cough medicine products for children under the age of six years old should be banned. While not bound by its advisory committees? recommendations, the agency announced it will make a decision by spring whether or not to extend this advisory to children under the age of six.
Some proponents of an ?under six? ban have expressed frustration with the FDA for not immediately extending the cold medicine advisory per the panel?s recommendations. The delay, according to Dr. Diana Zuckerman, president of the National Research Center for Women and Families, ?enables major drug companies to continue to make millions of dollars selling families children?s could and cough medications that have never been proven effective.?
In November 2007, one month after manufacturers withdrew the drugs, two surveys found that 20 percent of parents with children under the age of two still planned to continue using the medicines. An additional 41 percent were either undecided or not familiar with the issue.
There is no evidence that children?s cough medicines help children suffering from colds, and there are growing reports of infant overdose from cough and cold drug toxicity. This can produce convulsions, rapid heart rates, loss of consciousness, and even death.
Source: Gardiner Harris, ?Renewed warning on cold medicines,? New York Times, January 18, 2008.









