FDA rejects call for ban on kids' cold medicines Fears raised that parents might start dispensing adult drugs
Associated Press October 3, 2008
But Food and Drug Administration officials at a public hearing yesterday 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 to 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," Jenkins said. "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 proved, critics say, and problems with the drugs send thousands of children 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
But he agreed with critics who say there's no proof the medicines work in children. "We don't see that adequate evidence of efficacy has been demonstrated in children to date," Jenkins said. Clinical studies to try to settle the issue could take years to complete and might not provide clear answers. "It really is a conundrum for us," he said.
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 younger than 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 children up to age 11. Now the agency is seeking more advice from doctors, industry and consumers - and officials are not giving a timetable for a decision.
The industry says OTC medicines have been used for decades in treating children's 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 about 30 years ago, no studies were done for children.
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.