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Drug Manufacturers Withdraw Children’s Over-the-Counter Cold Medicines

October 11th, 2007 by Dawn Mefford

Drugmakers pulled a series of children’s cold medications off store shelves today, and parents are advised to do the same if their home medicine cabinets include infant medications containing decongestants and antihistamines. 

Some of the withdrawn medicines include: Pediacare Infant Drops and Tylenol Concentrated Infant Drops (manufactured by Johnson & Johnson), Dimetapp Decongestant Infant Drops (manufactured by Wyeth), Triaminic Infant & Toddler Thin Strips (manufactured by Novartis) and Little Colds Decongestant Plus Cough (manufactured by Prestige Brands Holdings). 

The move comes two weeks after the Food and Drug Administration (FDA) came to a tentative agreement to recommend that these drugs’ labels contain a warning that parents not use the products in children under two years of age.  Current back-of-the box labels direct parents to consult a doctor before using these drugs on infants and toddler—while branding on the front of the boxes include the words “infant” and “toddler” in the products’ name. 

In weighing their recommendation, the FDA found that over the past four decades 54 children have died after being administered over-the-counter decongestant medicines and 69 children have died after being given antihistamines.  Overdose of these drugs in young children can occur as a result of even one or two extra drops of the medicines. 

While drug makers argued that the medicines are safe at recommended doses, critics point out that there are no recommended safe doses. 

The American Academy of Pediatrics usually recommends not giving infants any over-the-counter products.  Instead, they suggest using saline nose drops, humidifiers and time.  Colds and flu will generally resolve on their own using these recommended methods. 

 Many critics have been frustrated by the marketing of such drugs for infants even though there are no studies showing that such drugs work on such young children.  This lack of medical evidence led doctors and public health officials to petition the FDA to consider a ban on drugs like those pulled today. 

Today’s action was taken by the drugmakers independent of any FDA orders. 

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