Panel Pans Cold Medicine For Kids

Federal Health Advisers Say Cold Medicines Shouldn’t Be Used For Children Under 6

(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.

[rfcnj68]

I hate to say it but based on the statistics presented cold remedies have been around along time and to only have 92 deaths and it is believed 79 of those are due to parents%u2019 negligence that is pretty *** good if you ask me.

Now I realize that if I were the parent of one of the other 13 I would not agree but come on there are prescription drugs out there killing people everyday that are not being pulled. Not trying to be like some people that running around promoting healthier foods but I have found that instead of prescription medication for certain problems using whole food products is a better answer it has been for me. If anyone wants to know more about them send me an e-mail @ [e-mail] and I will forward you the information for whole foods.

[grammawhamma]

As a baby my grandchild was prone to ear infections requiring anti-biotics. Finially a doctor told me to start her on decongestants immediatly at the first sign of a cold. It worked...no more ear infections.

There was an article a few days ago about ear infections that are now resistant to anti-biotics. I really think the answer is to educate parents to dose their children properly. I agree with midgitviking that stupid parents will now try to guess a dose of adult medicine to give their child....dangerous move!! Put the children''s meds back on the shelf and EDUCATE parents.

[incog-nito]

OK, OK. Here''s what''s gonna happen. More parents will take their kids to the ER instead, waiting for 5 hours before being sent home. While there they are more likely to contract a serious hospital-borne illness, like the "superbug" that''s all over the news. Or, you could make sure the dosage is correct (by WEIGHT) and go nowhere near the maximum allowed, help your kids get a good night''s sleep which in turn helps them get better faster. Your choice.

[midgetviking]

This scares me. While I fully support a review of these medications, completely removing them from store shelves is not the answer. Instead of having a lower dose medication available, parents will take it upon themselves to "self-medicate" their children using adult medications, as they will be the only ones available. This will cause more harm and deaths. What is needed is an education program for the parents and doctors regarding the usage and safety of childhood medications.