WASHINGTON (CBS/AP) -- Cold and cough medicines do not work in children and should not be used in those younger than 6, federal health advisers recommended Friday.
The over-the-counter medicines should be studied further, even after decades in which children have received billions of doses a year, the outside experts told the U.S. Food and Drug Administration. The FDA is not required to follow the advice of its panels of outside experts but does so most of the time.
"The data that we have now is they don't seem to work," said Sean Henry, a University of Pennsylvania epidemiologist, one of the FDA experts gathered to examine the medicines, peddled as treatments for common cold symptoms. The recommendation applies to medicines containing one or more of decongestants, expectorants, antihistamines and anti-tussives.
The nonbinding recommendation is likely to lead to a shake-up in how the medicines - which have long escaped much scrutiny - are labeled, marketed and used. Just how and how quickly was not immediately clear.
In two separate votes, the panelists said the medicines should not be used by children younger than 2 or in those younger than 6. A third vote, to recommend against use in children 6 to 11, failed.
Earlier, the panelists voted unanimously to recommend the medicines be studied in children to determine whether they work. That recommendation would require the FDA to undertake a rule-making process to reclassify the medicines, since the ingredients they include are now generally recognized as safe and effective, which does not require testing. The process could take years, even before any studies themselves get under way.
Simply relabeling the medicines to state they should not be used in some age groups could be accomplished more quickly, FDA officials said.
Indeed, the drug industry could further revise the labels on the medicines to caution against such use. The Thursday-Friday meeting came just a week after the industry pre-emptively moved to eliminate sales of the nonprescription drugs targeted at children under 2.
Pediatricians pushing for greater restrictions told the FDA advisers Thursday that the over-the-counter medicines should not be given to children younger than 6, an age group they called the most vulnerable to any potential ill effects.
FDA officials and panelists agreed there is no evidence they work in older children, either.
Still, panelists held off from recommending against use in older children. Some said they feared such a prohibition would not eliminate use of the medicines by parents.
"They will administer adult products to their children because they work for them or feel they work for them," said the panel's patient and family representative, Amy Celento.
The drug industry says the medicines, used 3.8 billion times a year in treating cold and cough symptoms in children, do work and are safe. It says that more parent education is needed to avoid overdoses that in rare cases have been fatal.
A group of pediatricians petitioned the FDA this year seeking action on the medicines.
An American Academy of Pediatrics official told the experts Friday that the medications should be relabeled to tell parents they do not work in children under 6 and may be dangerous.
"Why not label these products with what we actually know?" asked David Bromberg, a pediatrician.
CBS News correspondent Wyatt Andrews reported that the cold and cough medicine industry admits that 92 deaths are connected to combination cold medicines - but claims 79 of them were due to misuse or overdose.
Drug manufacturers continue to maintain that administered correctly, the medicines are safe and effective for sick children over two years of age.
Posted by LS