Doctors Applaud Infant Cold/Cough Drug Recall

Pediatricians and other medical experts say the removal of infant cough and cold medicines from store shelves comes not a moment too soon, and nearly all agree that any benefits of the drugs do not outweigh their risks.

The products being voluntarily removed from the market include combinations of decongestants, expectorants and antitussives.

"This is a good step in protecting the safety of children, particularly young children," said Dr. Ian Paul, associate professor of pediatrics at Penn State College of Medicine in Hershey, Pa. "Kids under age 2 are our most vulnerable population... There is no proven benefit for any of these products, and some potential for side effects -- and occasionally, serious side effects."

The voluntary recall by the manufacturers of these products, intended for infants 0-2 years old, comes just a week before an Oct. 18-19 meeting of the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee to further evaluate the medications.


"This is a recognition by the companies making these [products] that, over the last decade, enough information has become available to swing the risk versus benefit ratio toward the risk side," said Dr. Richard Gorman, chair of the American Academy of Pediatrics section on clinical pharmacology and therapeutics.

"At the time these were approved, the FDA extrapolated adult data to children," he added. "In the last 25-30 years, that has been shown to be inaccurate, and occasionally dangerous."

Some FDA advisers have recommended an outright ban on the infant preparations due to safety concerns. But McNeil Consumer Healthcare, the maker of Tylenol and Pediacare brand products, maintained in a statement issued Thursday that the products are safe when used as directed.

"While most parents use these medicines appropriately and follow dosing directions, an assessment of available data on the use of pediatric cough and cold medicines has identified rare instances of misuse leading to overdose, particularly in infants under 2 years of age."

In addition to the 14 products manufactured by McNeil, similar store brand medicines will also be coming off the market, an industry spokesman told ABC News.

However, the recall doesn't affect other cough and cold formulas indicated for children 2 and older -- though the industry may soon institute labeling changes for these products to further emphasize that these products should not be administered to children under 2.

Risks Don't Justify Benefit

Last August, the FDA issued a public health advisory declaring that children under 2 shouldn't be given these remedies without a pediatrician's order due to the risk of serious adverse effects, including death.

The advisory, as well as the scheduled Oct. 18-19 meeting, was largely spurred by a petition in March by a group of doctors concerned over the widespread use of the drugs in children.

And the concern may be warranted. In January, a Centers for Disease Control and Prevention (CDC) study showed that more than 1,500 children under the age of 2 had to be taken to an emergency department due to serious health problems after taking these common remedies in 2004 and 2005. Three of these children died.

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