No Cold Meds For Kids Under 4

Children under 4 should not be given cough and cold medicines, companies that make those products said Tuesday in announcing new guidelines for their use.

The industry has been criticized by pediatricians for marketing over-the-counter cough and cold remedies for children under 6 despite a lack of evidence that they work, and reports of safety problems.

Linda Suydam, president of the Consumer Healthcare Products Association, said the companies were voluntarily making the change "out of an abundance of caution." The association represents leading manufacturers and distributors of nonprescription, over-the-counter medicines and nutritional supplements.

The companies will also add a warning to their product labels saying parents should not give young children antihistamines to make them sleepy. Antihistamines are used to relieve allergies.

Government health officials said last week the issue needed additional study.

Last week, FDA officials said at a public hearing they were uncomfortable with the lack of solid scientific data to support continued use of over-the-counter remedies with youngsters, particularly from ages 2-6.

Critics says the effectiveness of such medicines in children has never been proven, and problems with the drugs sent around 7,000 kids to the emergency room last year, reports CBS News correspondent Nancy Cordes.

"When a treatment is ineffective, its risks - unless zero - always exceed its benefits," Dr. Michael Shannon of Children's Hospital in Boston told the FDA panel.

"We don't see a public health emergency here as far as an inherent risk of the products," said the FDA's Jenkins.

But he agreed with critics who say there's no proof the medicines work in kids. "We don't see that adequate evidence of efficacy has been demonstrated in children to date," said Jenkins.

The FDA said Tuesday that it supported the manufacturers' action.

In a conference call with reporters, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, and other officials said that the label change "in no way supersedes" the FDA's ongoing evaluation of the safety and efficacy of OTC cough and cold medicines for children.

Asked if the FDA had requested that CPHA make the label changes, Woodcock said, "We certainly had discussions with them about changing the labels because we recognized that the rulemaking process will take several years at best."

Medicines with the new labels are starting to arrive on store shelves now (which is why the CPHA made the announcement). Woodcock said it usually "takes up to half a year" from the time a decision to change labels is made for medicines with new labels to begin showing up on shelves, so the decision by CHPA was made months ago and not in reaction to last week's hearing.

She said, "The timing was coincidental."

FDA will not require the removal of medicines with the old labels from store shelves (something not typically required during voluntary label changes). Accordingly, there will be a period where medicines with old labels are on shelves along with medicines with new labels. If parents have questions, the FDA said, they should contact their doctors or pharmacists.

The FDA had warned in January against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers - and officials are not giving a timetable for a decision.

U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds, a recent Boston University report found.

But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.