Kid cold medicine overdoses prompt FDA review

CDC report blames drugs, including popular over-the-counter brands, for 1,500 emergency room visits and 3 deaths.

By Aaron Smith, staff writer

NEW YORK ( -- The FDA is launching a broad review of children's cough and cold medicine - including some of the most popular brands sold over the counter - following a CDC report that blames these medications for overdoses in infants, three of them fatal.

The Food and Drug Administration received a citizens' petition on Thursday requesting a review of the medicines, prompting the review, said FDA spokeswoman Susan Cruzan.

Cruzan said the petition cited a recent report from the Centers for Disease Control that blamed the use of cold medicine for emergency room visits from 1,519 toddlers and infants, aged two years or younger between 2004 and 2005.

Three babies - ages 6 months or less - were found dead in their homes, according to the report. In two of the deaths, prescription medications were found in the infant's blood.

Overdoses were responsible for some - but not all - of the adverse events, said the CDC.

The report did not mention specific products, but it said that all three of the dead infants had high levels of pseudoephedrine, a commonly-used nasal decongestant, in their blood.

Popular children's cold medicine include Toddler's Dimetapp, made by Wyeth (down $0.60 to $48.82, Charts), as well as Little Colds, produced by Prestige Brands Holdings (down $0.21 to $11.29, Charts), and Infant Triaminic, made by Novartis (down $0.19 to $54.91, Charts). The news did not appear to affect the stock price for any of these companies.

Wyeth spokesman Douglas Petkus said Toddler's Dimetapp was not a major contributor to the company's revenue, though he did not break out specific sales figures. (Drug companies usually do not provide sales figures for over-the-counter products.)

"The vast majority of our products are used by adults and sold to adults," said Petkus.

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