February 11, 2009 4:04 PM
- Text
Infant Cold Medicines Recalled
(CBS/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.
"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."
Next week, the FDA will consider the possibility of banning these medicines for all children under 6, reports Andrews. Consumer groups say the industry is giving up the infant market in order to keep the rest of the under-6 market.
The FDA is reviewing the safety of cold medicines at the request of Baltimore health commissioner Dr. Joshua Sharfstein and other city officials who reported 900 Maryland children under the age of 4 overdosed on the products in 2004.
"I'd like to think they saw the evidence that the products are not safe and effective and they're doing the right thing," Sharfstein told CBS News' Barry Bagnato. "But we'd like to see broader action because we think the evidence justifies that, as well."
Baltimore city officials were joined by the American Academy of Pediatrics and prominent pediatricians around the country in their petition, which 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, too.
Scientists inside and outside the FDA have concluded that cough and cold formulations have never been shown to work in children under six years old, reports Andrews. Worse, overdoses of these cold formulas led to the deaths of 123 children between 1969 and 2006.
The challenge, he says, will be to convince parents to try old-fashioned methods, like 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 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.
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.
In a statement, the drug manufacturers essentially blame parents for the overdosing children, citing "rare patterns of misuse leading to overdose," reports CBS News correspondent Wyatt Andrews.
FYI: Read the complete list of recalled childrens medicines.
"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."
Next week, the FDA will consider the possibility of banning these medicines for all children under 6, reports Andrews. Consumer groups say the industry is giving up the infant market in order to keep the rest of the under-6 market.
The FDA is reviewing the safety of cold medicines at the request of Baltimore health commissioner Dr. Joshua Sharfstein and other city officials who reported 900 Maryland children under the age of 4 overdosed on the products in 2004.
"I'd like to think they saw the evidence that the products are not safe and effective and they're doing the right thing," Sharfstein told CBS News' Barry Bagnato. "But we'd like to see broader action because we think the evidence justifies that, as well."
Baltimore city officials were joined by the American Academy of Pediatrics and prominent pediatricians around the country in their petition, which 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, too.
Scientists inside and outside the FDA have concluded that cough and cold formulations have never been shown to work in children under six years old, reports Andrews. Worse, overdoses of these cold formulas led to the deaths of 123 children between 1969 and 2006.
"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 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 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.
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