FDA: Cold medicines too risky for tots

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FDA: Cold medicines too risky for tots

By LAURAN NEERGAARD, AP Medical Writer

32 minutes ago

WASHINGTON - Parents should not give sniffling babies and toddlers

over-the-counter cough and cold medicines — they're too risky for

tots so small, the government will declare Thursday.

The Food and Drug Administration still hasn't decided if the remedies

are appropriate for older children to continue using, officials told

The Associated Press.

Expect a decision on that by spring, the deadline necessary to notify

manufacturers before they begin production for next fall's cold

season.

For now, the FDA is issuing a public health advisory on Thursday to

warn parents to avoid these drugs for children under age 2 " because

serious and potentially life-threatening side effects can occur. "

It's not the first warning about cold remedies and tots: Drug

companies last October quit selling dozens of versions targeted

specifically to babies and toddlers. That same month, the FDA's own

scientific advisers voted that the drugs don't even work in small

children and shouldn't be used in preschoolers, either — anyone under

age 6.

Thursday's advisory marks the government's first ruling on the issue:

Don't give the drugs to children under 2. And it comes now because

the FDA is worried that parents haven't gotten that message despite

all the publicity last fall.

They may still have infant-targeted drugs at home, or they may buy

drugs meant for older children to give to hacking tots instead, said

Dr. Ganley, FDA's nonprescription drugs chief.

" We still have a concern, " Ganley said. " It falls out of people's

consciousness. We're still in the middle of cold season right now. "

Ganley said he is particularly concerned by recent surveys that

suggest many parents don't believe OTC cold remedies could pose a

problem, especially if they've used them with an older child who

seemed to get better.

Thursday's move is a good first step, said Dr. Sharfstein,

Baltimore's health commissioner, who petitioned the FDA last year to

end use of these nonprescription remedies by children under 6, a move

backed by the American Academy of Pediatrics.

The reason: There's no evidence that these oral drugs actually ease

cold symptoms in children so young — some studies suggest they do no

good at all. And while serious side effects are fairly rare, they do

occur. Indeed, the Centers for Disease Control and Prevention last

year reported that more than 1,500 babies and toddlers wound up in

emergency rooms over a two-year period because of the drugs.

" It's one thing if you're curing cancer, but we're talking about a

self-limiting illness, " said Sharfstein. " If there's really no

evidence of benefit, you don't want to risk the rare problem. Then

you're left with tragedy that you can't justify. "

The drug industry says these medicines are used 3.8 billion times a

year in treating children's cough and cold symptoms and are safe for

those over 2.

Health groups acknowledge that while low doses of cold medicine don't

usually endanger an individual child, the bigger risk is

unintentional overdose. For example, the same decongestants, cough

suppressants and antihistamines are in multiple products, so using

more than one to address different symptoms — or having multiple

caregivers administer doses — can quickly add up. Also, children's

medicines are supposed to be measured with the dropper or measuring

cap that comes with each product, not an inaccurate kitchen teaspoon.

Why is this an issue now? Child versions of cold remedies were

allowed on the market decades ago, when scientists thought that what

worked in adults would automatically work in children. Scientists

today know that is not always the case.

So the FDA is asking an even bigger question: Are OTC cold remedies

safe and effective for children under 12? The agency's advisers last

fall stopped short of recommending no use by children ages 6 to 11,

but they did call for more research to determine what effects the

medicines have in youngsters overall.

Separately, an internal FDA working group hasn't yet reached a

consensus about children 2 to 11 years old, but has been given a

February deadline to forward recommendations to agency leaders,

Ganley said in an interview Wednesday. The goal is a spring

announcement.

In the meantime, the FDA's advisory recommends for older children:

_Carefully follow the label's directions.

_Be very careful if you give more than one product to a child. If you

give two medicines that have the same or similar ingredients, a child

could overdose.

_Understand that these drugs only treat symptoms. Colds are viruses,

and the drugs will not make them go away any faster.