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 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 Maryland chapter of 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 convince 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.
“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 Berkelhamer, the academy’s national president, wrote the FDA last month. In multiple studies, they have “been found not to be effective in this population at all.”
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