FORT WASHINGTON, Pa. (1010 WINS) -- 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.
1010 WINS AUDIO: Juliet Papa Reports
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Cold medicines being withdrawn include: Johnson & Johnson Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth's Dimetapp Decongestant Infant Drops, Novartis' Triaminic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 labeling to the medicines indicating they are not to be used in young children.
Current labeling directs parents to consult a doctor before administering the drugs to infants and toddlers and many doctors say they are safe to use.
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.
Shares of New Brunswick-based Johnson and Johnson rose 22 cents to $66.05 while shares of Madison-based Wyeth fell 17 cents to $45.99. Shares of Novartis AG, whose U.S. headquarters are based in East Hanover, dipped one cent to $54.07 and Prestige Brands Holdings Inc. fell 7 cents to $11.09.
Johnson & Johnson's McNeil-PPC unit is withdrawing the following products from the U.S. market:
Concentrated Infants' Tylenol Drops Plus Cold
Concentrated Infants' Tylenol Drops Plus Cold & Cough
Pediacare Infant Drops Decongestant
Pediacare Infant Drops Decongestant & Cough
Pediacare Infant Dropper Decongestant
Pediacare Infant Dropper Long-Acting Cough
Pediacare Infant Dropper Decongestant & Cough
Read more about the recall from Johnson & Johnson here...
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