Friday, October 3, 2008
The Washington Post reports that FDA officials said they were uncomfortable with the lack of solid scientific data to support continued use of over-the-counter cough and cold medicines for young children. Ricardo Alonso-Zaldivar writes,
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.