A Food and Drug Administration (FDA) advisory panel voted to ban popular over-the-counter cold products intended for children under the age of 6.
The panel decided that there is no evidence that OTC cough and cold medicines have any effect on younger kids – and that more studies need to be done.
“The data that we have now is they don’t seem to work,” said Sean Hennessy, one of the FDA experts asked to examine the group of medicines.
The panel did not vote unanimously on the subject, so The F.D.A. is likely to ignore the advice.
An immediate recall of the products isn’t necessary because there’s no perceived dire threat to public health from cough and cold products.
The New York Times reports that the panel’s vote will force difficult choices for Johnson & Johnson, Wyeth and Novartis that make such products as Pediacare, Robitussin and Triaminic. If companies continue to market products for children under the age of 6 – and a child is injured – the tragedy could open its maker to considerable liability.
Manufacturers say that their products are safe and effective. And most problems associated with the medicines come from unintentional overdoses. Makers say educational campaigns could solve most problems.
The recommendation applies to medicines containing one or more of the following ingredients: decongestants, antihistamines and antitussives. It doesn’t apply to expectorants, though many of the medicines also contain that ingredient.
The FDA offers a great website for kid-related information. Go there to learn about vaccines, sunburns, braces for your teeth – and more.