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Overdose Fears Prompt Recall of Infant Drugs

Danger found in cough and cold medicines for kids under 2

By Jonas Oransky,  Newser Staff

Posted Oct 11, 2007 12:42 PM CDT

(Newser) – Several drugmakers have recalled over-the-counter cough and cold products for infants over concerns about fatal overdoses, Reuters reports. Johnson & Johnson Wyeth and Novartis are among those recalling medicines; CVS said it will remove the products and generic equivalents. One professor took the criticism one step further: “There are really no good studies demonstrating that these medications work.”

The trade association representing the companies stressed the drugs are safe when used as directed; Food and Drug Administration reviewers have called for warnings saying the medicines are unsafe for very young children. Fifty-four deaths with decongestants and 69 with antihistamines were reported in 1969-2006. The FDA will meet with outside advisers before making firm decisions on new instructions.

CVS pharmacy, seen here in this Feb. 1, 2007, file photo, is the first national chain to announce the removal of the offending products from store shelves. (AP Photo/Steven Senne, file)
CVS pharmacy, seen here in this Feb. 1, 2007, file photo, is the first national chain to announce the removal of the offending products from store shelves. (AP Photo/Steven Senne, file)   (Associated Press)
US NEWS BABYZEKE 4 KC
US NEWS BABYZEKE 4 KC   (KRT Photos)
Novartis headquarters is seen in this file photo. Novartis and Prestige Brands Holdings are recalling their oral infant cough and cold medicines due to the unexpected discovery that misuse can lead to overdose.
Novartis headquarters is seen in this file photo. Novartis and Prestige Brands Holdings are recalling their oral infant cough and cold medicines due to the unexpected discovery that misuse can lead to...   (Getty Images)
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