Rejecting pleas from pediatricians for an immediate ban on over-the-counter cough and cold medicines for young children, FDA officials said 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 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.
"We do not want to do something that we think will have a positive impact, only to have an unintended negative," Jenkins said. "That could be an even worse situation."
With a new cold season coming, pediatricians have been 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 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 an FDA panel.
But Jenkins responded, "We don’t see a public health emergency here as far as an inherent risk of the products." He agreed, however, with critics who say there is 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.
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.
The industry says over-the-counter medicines have been used for decades in treating kids’ colds and are safe for those older than 2. Nonetheless, manufacturers plan 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.