FDA says Child Cold Remedies May be Harmful

Posted on November 21, 2007
Filed Under Health |

Certain well known cough and cold medicines should not be used on children younger than age 6 says the Food and Drug Administration (FDA). A review of the evidence showed that these over-the counter medications do not appear to be effective in young children and may even be harmful. Mary E. Tinetti of Yale University chaired the FDA advisory committee to review the child medications and stated….”The sentiment here is that they should not be used.”

The measure reflects a 13 to 9 vote to disallow such products for young children. The vote came with evidence from the such bodies as the Centers for Disease Control and Prevention that at lease 1,500 children below the age of 2 had complications from cough and cold remedies including heart and neurological problems, convulsions and at least 123 deaths in 2004 and 2005. However, the advisory committee decided against implementing the same measure for older children (ages 6 to 11); despite evidence that the products do not show any effectiveness for this age range either.

Several major manufacturers voluntarily withdrew the products designed for children such as Dimetapp Decongestant Plus Cough Infant Drops, Tylenol Concentrated Infants Drops Plus Cold and Robitussin Infant Cough DM Drops. It should be noted that the companies maintain that the remedies are safe but withdrew there products due to complications which they suggest could occur with misuse of the products.

The advisory panels recommendations also include anti-histamines used to treat allergies. This obviously represents a major blow to companies of such remedies which total $300 million in revenue a year. Perhaps the biggest problem may be parents who have relied on these products for years and to get the word out that these remedies should not be used or even marketed to children under 6 years of age. “FDA and the companies should work quickly to end marketing of cough and cold products for children under age 6,” said Sharfstein a Baltimore health official who leads a petition to stop such marketing.

Major manufacturers such as Tylenol, Dimetapp and Robitussin spend $50 million a year in marketing of such products.

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