A controversy over children’s cough and cold medications is underway with consumer groups and medical experts calling on the FDA to make them available only by prescription and a top government health official rejecting the call, saying it might cause unintended harm. The Food and Drug Administration officials last summer had issued a warning against giving cold medicines to children under the age of 2 because of the possibility of serious side effects. Now at a public hearing they said they were considering increasing the age to 6 years, due to the lack of solid scientific data to support the continued use of OTC medications in children under 6 years.
According to FDA estimates as many as 800 cough and cold medicines are readily available in the US market. According to Information Resources, a market research firm, companies are selling an estimated 95 million packages of pediatric cough and cold medications each year. According to the Nielsen Co. market research firm U.S. families spend at least $286 million a year on such cough and cold remedies for children, and a recent Boston University report found that 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.
Dr. John Jenkins, who heads the FDA's Office of New Drugs said, "We do not want to do something that we think will have a positive impact, only to have an unintended negative. We're very concerned that we'd see a shift in people using adult products. That could be an even worse situation."
An estimated 7,000 children go to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking as a result of cough and cold medicines. Experts agree that the low doses of a medicine are not likely to cause a problem; the main problem arising from unintentional overdoses.
Joshua Sharfstein, MD, the Baltimore City Commissioner of Health, urged FDA officials to not only take off the market cough and cold medicines for children under 6 but also said the regulators should recall millions of those packages currently on store shelves. "Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children," he said.
"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 Jenkins, though he agreed that there is no proof these medicines work. "We don't see that adequate evidence of efficacy has been demonstrated in children to date," said Jenkins. Studies to prove there efficacy could take years to reach a conclusion he added. "It really is a conundrum for us," said Jenkins.
David Bromberg, MD, a pediatrician from Frederick, Md., who testified on behalf of the American Academy of Pediatrics said, "The available data show cough and cold products to be ineffective for children with cough and cold symptoms. In the absence of evidence of efficacy, any risk associated with these drug therapies is unacceptable."
The FDA and the drug companies feel that children under the age of 2 should not be given OTC medications while the American Academy of Pediatrics says children under 6, and should not be given OTC medications because of the risk of serious side effects — a conclusion seconded last year by a panel of outside advisers to the FDA. Officials say the debate could go on for years and it is likely to take the FDA a similar amount of time to reach a decision on children’s cold medicines.