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.
"That is a concern for us," said Jenkins. "We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation."
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.
"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. Clinical studies to try to settle the issue could take years to complete, and may not provide clear answers.
"It really is a conundrum for us," said Jenkins.
Parents might also be frustrated by the conflicting advice.
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 own 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.
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.
The industry says OTC medicines have been used for decades in treating kids' colds and are safe for those older than 2. Nonetheless, manufacturers are planning to carry out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.
It turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.
Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.
The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.
The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.
"The data clearly show a majority of adverse events are direct result of misuse of our products," said Linda Suydam, who heads the industry group.
Baltimore health commissioner Dr. Joshua Sharfstein sought to reassure FDA officials worried about unintended consequences if the government moves to restrict the medications and parents start dispensing adult drugs to their preschoolers. Sharfstein said the state of Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.
"The feared increases in poisonings simply did not happen," said Sharfstein. "In fact, the opposite occurred."