The Food and Drug Administration has issued a public health advisory warning parents that over-the-counter cold medicines are too risky for toddlers and infants.
Recent studies suggest that the cold remedies do not work in young children under two years of age.
The FDA says the drugs can cause serious and potentially life-threatening side effects.
Instead, doctors recommend parents offer sick toddlers lots of fluids and saline drops and humidifiers to help them breath easier.
Agency Worried That Parents Did Not Get the Message
The FDA is worried that parents did not get the information about the risk, 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 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 says he was concerned by recent surveys that suggest many parents don't believe OTC remedies could pose a problem.
One California mom told ABC News that she has always been worried about the medicines.
"I just don't use them,"Celeste Oberfest said. "My daughter has a cough right now and we are just suffering through."
The FDA still hasn't decided if OTC decongestants, antihistamines and cough suppressants are appropriate for older children, officials told The Associated Press.
Thursday's move is a good first step, said Dr. Joshua Sharfstein, Baltimore's health commissioner. He petitioned the FDA last year to end use of non-prescription cold remedies by children under six, a move backed by the American Academy of Pediatrics.
"That is the right advice for children under age two because these products have not been shown to work for them, and it can be dangerous," he explained.
At present, there's no scientific evidence that the oral drugs actually ease cold symptoms in children so young. Other studies have suggested they do no good at all. While serious side effects are rare, they do occur. The Centers for Disease Control and Prevention last year reported that more than 1,500 young children were seen 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."
Why Is This An Issue Now?
Cold remedies for children came on the market decades ago, when scientists thought that what worked in adults would automatically work in children. Today, scientists know that is not always the case.
In fact, the FDA never formally allowed infant-targeted cold remedies in the first place; Ganley said they evolved through a legal loophole.
But the FDA is investigating an even bigger question: Are OTC cold remedies safe and effective for children under 12? The agency's advisers last fall called for no use by the under-six years crowd only, but did recommend more research to determine the medicines effect in children overall.
The drug industry says these medicines are used 3.8 billion times a year in treating childrens' cough and cold symptoms and are safe for those over two.
Health experts say say the bigger risk is unintentional overdose of a child. For example, the same ingredients are in multiple products, so using more than one for different symptoms can quickly add up. Also, childrens' medicines are supposed to be measured with the dropper or measuring cap that comes with each product, not an inaccurate kitchen teaspoon.
An internal FDA working group has a February deadline to recommend to agency leaders any action for 2- to 11-year-olds, Ganley said. An announcement may come as soon as this spring.
The FDA's has this advice for children over two years of age:
- If you try these drugs, carefully follow label directions.
- Avoid giving a child more than one product. If you do, make sure they don't contain some of the same or similar ingredients.
- Understand that these drugs only treat symptoms. Colds are viruses, and the drugs will not make them go away any faster.
Source: Associated Press, ABC News