Products with existing labeling will not be removed from store shelves but will gradually be replaced
© AFP/File Robert Sullivan

WASHINGTON (AFP) - "Leading manufacturers of these medicines are voluntarily transitioning the labeling on oral over the counter pediatric cough and cold medicines to state 'do not use in children under four years of age'," said a statement issued Tuesday by the Consumer Healthcare Products Association.

The announcement comes a week after federal authorities said they had little data on the benefits of such medicines for very young children.

But the US Food and Drug Administration decided not to pull them from the market, fearing parents might begin administering adult cough and cold medicine to their offspring if they did so.

Labels on the pediatric medicines will continue to carry dosing instructions for children four and above, the group said.

Products with existing labeling will not be removed from store shelves but will gradually be replaced with products containing the new labels and packaging during the 2008-2009 cold season, it said.

Manufacturers are also adding language to labels of products containing antihistamines, warning parents not to give them to children to make them sleepy, the statement said.

In January 2008, after the FDA warned of the serious risk such medicines pose for children younger than two, pharmaceutical firms stopped marketing them for that age group.

American pediatricians welcomed the move, although they would like to see it extended for children up to the age of five.

The FDA is currently studying the effectiveness of over the counter cough and cold medicines for children under the age of 12, but a decision could be a year away.

©AFP