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Children under 4 should not be given over-the-counter cough and cold remedies, drug companies said Tuesday, in a concession to pediatricians who doubt the drugs do much good and worry about risks.

The drug makers said they will also add a warning that parents should not give antihistamines to children to make them sleepy. These are allergy-relief medications often found in medicines that combine several ingredients to treat a variety of symptoms.

The new measures "reflect industry’s overall commitment to the continued safe and appropriate use of children’s oral OTC cough and cold medicines," Linda Suydam, president of the Consumer Healthcare Products Association, said in announcing the changes on behalf of the companies."We are doing this voluntarily out of an abundance of caution," she added.

The new instructions will appear on products distributed for the coming cold season. Last year, the companies pulled medicines for babies and tots under 2 from the market.

Pediatricians, who have been calling for a ban on OTC cough and cold remedies for children under 6, welcomed the industry’s latest shift.

"It’s a huge step forward," said Dr. Joshua Sharfstein, Baltimore’s health commissioner. "There is no evidence that these products work in kids, and there is definitely evidence of serious side effects."

Problems with OTC cough and cold medicines send some 7,000 children to hospital emergency rooms each year, with symptoms including hives, drowsiness and unsteady walking. Many kids overdose by taking medicines when their parents aren’t looking.

Since a majority of the problems involve 2- to 3-year-olds, the industry’s new instructions, if followed by parents, should help.

"The 2- and 3-year-olds are definitely the highest risk," said Sharfstein. "More than 50 percent of the problem is with these kids. "If they don’t have this stuff around the home, they’re less likely to grab it and ingest it."

Pediatricians still support recalling the medicines for children under 6, and the Food and Drug Administration is studying their effectiveness for children under 12. But federal health officials said at a public hearing last week that it could take them a year or more to make a final decision and order changes.

For more information about food safety litigation, contact the Smith & Vanture firm by visiting our firm’s web site or calling our offices at (866) 735-1102 ext. 515.

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