WASHINGTON Drug makers on Thursday voluntarily pulled kids' cold medicines off the market less than two weeks after the government warned of potential health risks to infants.
Products aimed at children under the age of two are being removed from store shelves due to "rare instantances of misuse" that could lead to accidental overdose, a trade group that represents over-the-counter drug makers said.
Cold medicines being withdrawn include: Johnson & Johnson Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth's Dimetapp Decongestant Infant Drops, Novartis' Triaminic Infant & Toddler Thin Strips and Prestige Brands Holdings' Little Colds Decongestant Plus Cough.
CVS Caremark Corp. said Thursday morning it would remove the affected products as well as CVS-brand equivalents from store shelves.
Late last month the Food and Drug Administration tentatively recommended adding the words "do not use in children under two years" to product labeling. Current labeling directs parents to consult a doctor before administering the drugs to infants and toddlers. Government scientists also said there is little evidence that cold medicines actually work in younger children.
FDA will formally consider revising labeling at a meeting scheduled for Oct. 18-19.
After reviewing reports of side effects over the last four decades, FDA found 54 child fatalities from over-the-counter decongestant medicines. The agency found 69 reports of children's deaths connected with antihistamines, which are used to treat runny noses.
Some recalled medicines, incluing the "Little Colds" package.
The Consumer Healthcare Products Association, which represents drug makers, said it will conduct a multiyear campaign to educate parents and physicians on safe use of cold medicines.
The trade group stressed in a statement that the "medicines are, and have always been, safe at recommended doses."
However, industry critics challenged this statement.
"When it comes to children under age two there are no recommended doses on these products so it's not reasonable to claim they are safe and effective when used as directed," said Dr. Joshua Sharfstein, Baltimore's health commissioner.
FDA is reviewing the safety of cold medicines at the request Sharfstein and other Baltimore city officials, who reported 900 Maryland children under four overdosed on the products in 2004.
Shares of Johnson and Johnson rose 22 cents to $66.05 while shares of Wyeth fell 12 cents to $46.03. Shares of Novartis AG dipped one cent to $54.22 and Prestige Brands Holdings Inc. fell 6 cents to $11.10.
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