Recall of Cold Medicine Sought by Doctors


Pediatricians are asking the Food and Drug Administration to recall cold medicine for children under six years old. A public hearing is scheduled for later today. Doctors are concerned that the risks of the medicine are too great, and question the benefits they may have. Furthermore, some doctors claim there isn’t much evidence that supports the use of over-the-counter cold medicines for children under six. According to Dr. Joshua Sharfstein, health commissioner of Baltimore, “There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under six.”

The FDA warned against giving over-the-counter medication to children younger than two earlier this year, and was expected to decide at the time on giving medicine to children up to 11. However, the government agency decided to wait to hear more from doctors, consumers, and the industry.

The industry response is based on standards set 30 years ago by the FDA when there were no separate studies done on children. The industry claims that these medicines are safe to use on children older than two. However, drug manufacturers have begun conducting their own studies on the most common ingredients, and voluntarily stopped selling cold and cough medicines to young children and toddlers last fall.

The issue is that because the same ingredients can be found in multiple types of medicine, there is a danger of an accidental overdose. Using a cough syrup and a decongestant together on a child can have dangerous consequences. Some 7,000 children are sent to hospitals every year for this very reason. Emergency rooms see symptoms ranging from drowsiness and hives to problems with balance.

The Consumer Healthcare Products Association, representing the manufacturers, claims the errors are preventable, and that it is not the ingredients in the medicine. They have begun a campaign aimed at doctors, parents, and day care providers on the importance of correct storage and reading the directions of the medicine.

Doctors are still not convinced that any medicine should be given to children for colds since they usually clear up after a few days on their own. Their recommendation is that children get rest and drink plenty of fluids. However, the Nielsen Co. market research firm has estimated that children’s cold and cough medicine is a nearly $300 million business annually. Nearly ten percent of children are given a cold medicine during any given week, most of this to children between two- and five-years-old.

After the withdrawal of cold medicines last fall, there was an almost immediate drop in calls to poison control centers by parents whose children had overdosed. Calls involving children younger than two dropped nearly 40 percent from 99 to 60.