Drug makers pull infant cold meds amid safety concerns

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 instances 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Cold medicines being withdrawn include: Johnson & Johnson Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth's Dimetapp Decongestant Infant Drops, Novartis' Triaminic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 Johnson and Johnson rose 22 cents to $66.05 while shares of Wyeth fell 17 cents to $45.99. Shares of Novartis AG dipped one cent to $54.07 and Prestige Brands Holdings Inc. fell 7 cents to $11.09.

Copyright 2007 The Associated Press.