Oct 11, 2007 4:45 pm US/Eastern
Drug Companies Pull Infant Cold Medicines
Major Drug Makers Voluntarily Pull Products Following Gov't Warning
WASHINGTON (CBS) ―
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Cold medicines being withdrawn include: Johnson & Johnson Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth's Dimetapp Decongestant Infant Drops, Novartis' Triaminic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 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.
Scientists inside and outside the FDA have concluded that cough and cold formulations (these are cold "formulations" that usually combine antihistamines and decongestants) have never been shown to work in children under 6 years old, CBS News correspondent Wyatt Andrews reports.
Worse, overdoses of these cold formulas led to the deaths of 123 children between 1969 and 2006. FDA scientists are saying in other words, this stuff doesn't work and may not be safe, Andrews reports.
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."
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 four 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."
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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