FDA: No Cough, Cold Medicine For Children Under 2

Risks Not Worth Benefits, Doctors Say

The Food and Drug Administration issued a public health advisory warning parents to avoid giving over-the-counter cough and cold medicines to children under age 2.

They said that the side effects are series and potentially life-threatening.

In October, drug companies quit selling 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. They believe the medicine is a waste of money.

"If medicines don't work, any side effects they cause, even if they're rare and even if they're relatively mild, aren't worth it," said Dr. Hartley Rotbart, with the infectious disease department at Children's Hospital in Aurora.

Now 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."

Parents are also warned to be careful if they store such medications.

"They're tasty medicines. They're colorful medicines. And they're very attractive sitting on the counter," Rotbart said.

In fact, medical overdoses are too common in the U.S., leading to 1,500 cases each year.

"At Children's Hospital we see two to three cases a year," Rotbart said.

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."

Local pediatricians such as Dr. Stephanie Stevens said they've been giving this same advice for years.

"Pretty much my whole career," Stevens said.

She's seen children overmedicated.

"It's scary. And there's a lot of guilt associated with the parents' standpoint too. And they think they're doing the right thing. Parents are always trying to do the right things for their kids," Stevens said.

One-year-old Luke Pitrusu came into Advanced Pediatrics on Thursday with a strong cough and two ear infections.

He'll get a prescription specifically tailored to his condition.

But his mother had to make an appointment, miss time at work, pay the co-pay and then go to the drug store instead of simply using the medicine around the house.

"It's hard. You feel bad for them. You know what you can take. They can't talk to you. They can't tell you what hurts. You just want to make them feel better and you feel better because it makes for a long day or night, or whatever it is," Suzanne Pitrusu said.

The drug industry said 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.

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.

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.

    With the warning, some parents are looking for alternative ways to fight off the sniffles.

    Many doctors may recommend Humidifiers. They can help a stuffy nose by loosening secretions, making it easier to blow the nose or breathe. Saline drops are another option to loosen secretion.

    Rotbart said a recent academic study confirmed what grandmothers have been saying for years: try honey. For kids 15 months of age and older, a teaspoon of honey mixed with milk, apple juice, tea or straight up can help control colds and coughs.