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Drug Manufacturers Pull Infant Cold Medicines Off Market Including Pediacare, Dimetapp, and Tylenol Infant Drops
Thursday, October 11th, 2007

We previously wrote about the FDA’s warning to parents concerning giving cough or cold medicines to children under the age of 2.

Today, drug manufacturers announced that they were voluntarily pulling infant cold medicines off the market following a tentative recommendation late last month by the FDA that the words "do not use in children under two years" should be added to the products’ labeling. Reviewing reports of side effects from these medicines, the FDA had found 54 child fatalities from over-the-counter decongestant medicines, and 69 reports of children’s deaths connected with antihistamines (frequently used to treat runny noses).

Cold medicines being withdrawn include: Johnson & Johnson’s Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth’s Dimetapp Decongestant Infant Drops, Novartis’ Triaminic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. The medicines come in tiny, droplet-size doses, but parents occassionally do not consult or follow directions from physicians, which can lead to accidental overdose.

Read more about the announcement here.

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