WASHINGTON - Parents should not give sniffling babies and toddlers over-the-counter cough and cold medicines - they're too risky for children 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 said.
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 babies: 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 the publicity last fall.
They might still have infant-targeted drugs at home, or they might buy drugs meant for older children to give to sick babies 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.
Today'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. And although 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 although low doses of cold medicine don't usually endanger a 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 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.