Babies' cold drugs pulled from shelves: What's a parent to do?

WASHINGTON — Drug makers pulled cold medicines targeted for babies and toddlers off the market Thursday, leaving parents to find alternatives for hacking coughs and runny little noses just as fall sniffles get in full swing.

The move by over-the-counter drug manufacturers comes a week before government advisers were to debate the medicines' fate.

The withdrawal includes medicines aimed at children younger than 2, after the Food and Drug Administration (FDA) and other health groups reported deaths linked to the remedies in recent years, primarily from unintentional overdoses.

A remaining question is whether children younger than 6 should ever take these nonprescription drugs, which include Dimetapp, PediaCare, Robitussin and others.

It was not clear why the announcement was made Thursday, as the issue has been brewing for some time.

The products have been under increased scrutiny since Baltimore's health commissioner, Dr. Joshua Sharfstein, petitioned the FDA in March to look closely at the safety and effectiveness of cough and cold medicines for children 6 and younger.

The petition — joined by the American Academy of Pediatrics and prominent pediatricians around the country — argued that oral cough and cold medicines don't work in children so young and pose health risks not just for babies but for preschoolers.

"Pediatricians are taught these products don't work and may not be safe. Yet almost every parent uses them," said Sharfstein, a pediatrician.

The challenge, he said, will be to persuade parents to try old-fashioned methods, such as suctioning out infants' noses or using salt-water nose drops.

"If you can actually pull a booger out with a suction device, people can feel better," Sharfstein said.

The Consumer Healthcare Products Association, which represents drugmakers, said Thursday that manufacturers were voluntarily ending sales of over-the-counter oral cough and cold products aimed at infants. The list includes infant drops sold under the leading brand names Dimetapp, Little Colds, PediaCare, Robitussin, Triaminic, and versions of Tylenol that contain cough and cold ingredients.

CVS Caremark added that it would also end sales of CVS-brand equivalents.

"It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," said Linda Suydam, president of the industry trade group.

The American Academy of Pediatrics disagreed. It said, in general, the drugs shouldn't be used for colds in young children.

"This is not a situation in which pediatric data are lacking and we are unable to say one way or the other," Dr. Jay Berkelhammer, the academy's president, wrote the FDA last month. In studies, they have "been found not to be effective in this population at all."

The companies withdrawing the products — McNeil Consumer Healthcare, Novartis Consumer Health and Wyeth — represent at least 95 percent of the market, the trade association said. Sales of cold remedies to children amounted to $311 million in the past year, excluding Wal-Mart, according to the Nielsen Co. That was about 8 percent of the entire over-the-counter cough and cold market.

No one knows how many children have had adverse reactions to over-the-counter cough and cold medicines, but the federal Centers for Disease Control Prevention (CDC) reported earlier this year that it found at least 1,500 children younger than 2 suffered complications in 2004 and 2005.

An FDA review prepared for next week's meeting describes dozens of cases of convulsions, heart problems, trouble breathing, neurologic complications and other reactions, including at least 54 deaths involving decongestants and 69 involving antihistamines.

In August, the FDA issued an advisory telling parents not to use cough and cold products in children younger than 2 unless instructed by a health-care professional. Stronger labeling will be one issue before the FDA advisory committee scheduled to meet Thursday for two days to discuss cough and cold products.

FDA officials praised the drugmakers' withdrawals Thursday as important for protecting babies.

For other youngsters, parents should understand that cold remedies treat only symptoms; they don't make viruses go away faster, stressed FDA pediatrician Dianne Murphy.

"What's the risk? That's what this whole meeting is about," she said. "You need to weigh 'Is that symptom that important to treat?' "

Most coughs shouldn't be suppressed; that's how the body clears the lungs, she added. Low-grade fevers are how the body fights infection.

Health groups said 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 a kitchen teaspoon.

Material from The Associated Press, Newsday and The Washington Post is included in this report.