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 today.
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 today 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.
Today'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. Charles 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. Joshua 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.