FDA: Cold Medicines Too Risky for Tots

[January 17, 2008]  WASHINGTON (AP) -- Parents may be left with only love and lots of liquid to give their sniffling babies and toddlers now that the government is declaring over-the-counter cough and cold medicines too risky for tots.

The Food and Drug Administration was issuing that warning Thursday to parents of children under 2.

It's a move expected for months: Drug companies last October quit selling dozens of versions of nonprescription cold remedies targeted specifically to babies and toddlers. That month, the FDA's scientific advisers also voted that the drugs don't work in small children and shouldn't be used in preschoolers, either -- anyone under age 6.

The FDA still hasn't decided if OTC decongestants, antihistamines and cough suppressants are appropriate for older children, 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, FDA's first official ruling focuses on youngsters under 2, warning that "serious and potentially life-threatening side effects can occur."

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 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 was particularly struck by recent surveys that suggest many parents don't believe OTC remedies could pose a problem, especially if they've given them to an older child without harm.

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 nonprescription cold 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."

Specialists are back to recommending old-fashioned steps, such as plenty of fluids and rest, saline drops to loosen stuffy noses, and humidifiers while sleeping.

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

In fact, 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 just by the under-6 crowd, but did recommend more research to determine the medicines' effects in children overall.

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 ingredients are in multiple products, so using more than one for 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.

An internal FDA working group has a February deadline to recommend to agency leaders any action for 2- to 11-year-olds, Ganley said. The goal is a spring announcement.

Meanwhile, the FDA's advice for children over 2:

• 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.

[Associated Press; By LAURAN NEERGAARD]

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