FDA Panel Weighs Ban on Kids' Cold Medicines

In a statement summarizing the group's expected testimony before the FDA committee on Friday, the CHPA defended both the safety and the effectiveness of over-the-counter children's cold medications.

"Both placebo-controlled and active comparator studies (eight in total) show these medicines are effective in reducing cough and cold symptoms in children," the CHPA stated. In addition, "in a recent national survey, 91 percent of parents using these products reported that these medications made them or their child feel more comfortable, and 89 percent of parents said OTC cough medicines helped their child cough less."

As for child safety, the CHPA said that "serious adverse events associated with over-the-counter cough and cold medicines are very rare," and are almost always caused by overdose, "which underscores the need for proper storage and safekeeping of these medicines."

But Shannon remains concerned. "These drugs interact with other drugs. These drugs have exaggerated effects on children who have other illnesses," he said.

And nothing conquers the common cold, he added.

"We have to accept the fact that there are no real treatments for the cold," Shannon said. "It's a mistake to think that there are medications that are really going to make a cold go away sooner or make the child feel much better. Medication for fever works, but these medications for cough suppression do not treat the common cold."

Another expert agreed with Shannon.

"Colds take a lot of time to nurture, and the medicines don't really speed up that process at all," said Catherine Tom-Revzon, clinical pharmacy manager at Children's Hospital at Montefiore in New York City.

Tom-Revzon believes that rather than risking potential harm from these medications, it's better to remove them from the market.

For children with colds, Tom-Revzon recommends giving lots of fluids, using a misting humidifier and putting an extra pillow under the child's head to help drain fluids. "If the child has a high fever and doesn't want to eat or drink, something more serious may be going on, and the child should be brought to the doctor," she said.

An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine.

Most of the deaths involved children younger than 2.

On Sept. 28, the FDA announced that the makers of almost 200 unapproved prescription medicines containing the ingredient hydrocodone must cease making these products for children under 6 by Oct. 31.

Hydrocodone, a narcotic, is commonly used to ease pain and cough. According to the Times, many of the children's hydrocodone products currently on the market have been around for decades but never received approval from the modern-day FDA.

More information

For more on cold remedies for children, visit the American Academy of Pediatrics.

SOURCES: Catherine Tom-Revzon, Pharm.D, clinical pharmacy manager, Children's Hospital at Montefiore, New York City; Michael Shannon, M.D., M.P.H., chief, Division of Emergency Medicine, Children's Hospital, Boston; Oct. 18, 2007, statement, Consumer Healthcare Products Association, Washington, D.C.; Sept. 28, 2007, The New York Times

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