Cold medicines for tots, babies taken off market

Deaths have been linked to some of the remedies.

WASHINGTON (AP) — 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 represented a pre-emptive strike by over-the-counter drug manufacturers — a week before government advisers were to debate the medicines’ fate. But it doesn’t end concern about the safety of these remedies for youngsters.

Thursday’s withdrawal includes medicines aimed at children under age 2, after the Food and Drug Administration and other health groups reported deaths linked to the remedies in recent years, primarily from unintentional overdoses.

A remaining question is whether children under 6 should ever take these nonprescription drugs.

Baltimore city officials filed a petition with the FDA — joined by the American Academy of Pediatrics and prominent pediatricians around the country — arguing that oral cough and cold medicines don’t work in children so young, and pose health risks not just for babies but for preschoolers, too.

“Pediatricians are taught these products don’t work and may not be safe. Yet almost every parent uses them,” said Dr. Joshua Sharfstein, Baltimore’s health commissioner and a pediatrician, who blames ads that overpromise relief.

The challenge, he says, will be to persuade parents to try old-fashioned methods, like suctioning out infants’ noses or using saltwater 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 announced 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, Pediacare, Robitussin, Triaminic, Little Colds, and versions of Tylenol that contain cough and cold ingredients.

CVS Caremark Corp. 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 disagrees. It said in general the drugs shouldn’t be used for colds in small 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 multiple studies, they have “been found not to be effective in this population at all.”

The FDA is bringing its scientific advisers together Oct. 18-19 to debate the issues, but its own preliminary review concluded that very young children shouldn’t take some of these commonly used medicines. And while the FDA’s main focus is on children under 6, it also will ask if there’s evidence that these drugs work in children up to age 12.

FDA 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 any faster, stressed FDA pediatrician Dr. Dianne Murphy, who urged parents to consult their pediatricians.

“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.”