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FDA says ban of kids cough medicines unsound

WASHINGTON — A top government health official Thursday rejected pediatricians' calls for an immediate ban on over-the-counter cough and cold medicines for young children, saying it might cause unintended harm.

But Food and Drug Administration officials at a public hearing also said they were uncomfortable with the lack of solid scientific data to support continued use of OTC remedies with youngsters, particularly from ages 2-6.

A ban — as sought by leading pediatricians' groups — might only drive parents to give adult medicines to their youngsters, said Dr. John Jenkins, who heads the FDA's Office of New Drugs.

With a new cold season coming, pediatricians are urging the government to demand a recall of over-the-counter cough and cold medicines for children younger than 6. The effectiveness of the medicines in children was never proven, critics say, and problems with the drugs send thousands of kids to the emergency room every year.

"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.

Clinical studies to try to settle the issue could take years to complete, and may not provide clear answers.

The American Academy of Pediatrics says OTC products are ineffective for treating coughs and colds in children under 6, and should not be given because of the risk of serious side effects — a conclusion seconded last year by a panel of outside advisers to the FDA. But the FDA's advice is that parents should not give the medications to tots under 2, a position shared by the drug companies.

In January, FDA 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.

FDA says ban of kids cough medicines unsound 10/02/08 [Last modified: Wednesday, November 3, 2010 2:33pm]
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