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 voluntary change in advice to parents comes less than a week after federal health officials said they also saw little evidence that the drugs work. But government officials were afraid that taking the medicines off store shelves might prompt parents to give their children adult medicines.
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.
Leading cough and cold brands include Dimetapp, Pediacare, Robitussin, Triaminic, Little Colds and versions of Tylenol that have ingredients to treat cold symptoms. U.S. families spend at least $287 million a year on cold remedies for kids, according to Nielsen Co. statistics that do not include Wal-Mart sales.
The industry also said it is expanding an educational campaign aimed at getting parents to be more careful about giving their kids cough and cold medicines.
Parents should never:
—Give adult medicines to a child.
—Give two or more medicines with the same ingredients at the same time.
—Give antihistamines to make a child sleepy.
—Give the exact recommended dose, using the measuring device that comes with the medicine.
—Keep OTC medicines out of sight and out of reach.
—Consult their doctor if they have any questions.
Colds usually clear up by themselves after a few days, and many doctors say rest and drinking plenty of fluids are all that's needed.