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FDA Panel Recommends Ban on Cold Medicines for Kids
Date:10/19/2007

Over-the-counter drugs are unsafe for children under 6, advisers say.,,

FRIDAY, Oct. 19 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel on Friday recommended a ban on over-the-counter cough and cold medicines for children younger than 6.

Citing a number of studies that showed the remedies were no better than a placebo, the outside experts also recommended the drugs be tested on children to see if they are effective.

"Even for adults, evidence that the drugs work is modest at best," said Dr. Mary E. Tinetti, chairwoman of the FDA panel and a professor at Yale University School of Medicine, according to The New York Times.

In two separate votes at the end of two days of hearings on the safety of the drugs for children, the advisers said the medicines shouldn't be used in children younger than 2 or in those younger than 6. A third vote, to recommend against use in children aged 6 to 11, failed, the Associated Press reported. An earlier vote recommended the use of the medications needs to be studied specifically in children.

The recommendations apply to medicines containing one or more of the following ingredients: decongestants, expectorants, antihistamines and antitussives, the AP reported.

The FDA does not have to follow its advisory panels' recommendations, but usually does.

A ban already has the support of safety experts at the FDA, who published a 365-page review last month that showed decongestants and antihistamines have been linked with 123 pediatric deaths since 1969.

Many outside experts were also in favor of restricting children's access to cold remedies as the hearing began Thursday.

"The panel should recommend that the FDA carefully reevaluate their existing approval of cough and cold preparations being marketed to children under 6," said Dr. Michael Shannon, chief of the Division of Emergency Medicine at Children's Hospital Boston. "Our hope is that they will agree that it is not appropriate to market these products to children."

The products covered in the debate include approximately 800 popular medicines sold in the United States under names such as Toddler's Dimetapp, Triaminic Infant and Little Colds. Experts estimate that Americans spend about $2 billion annually on these types of medications.

Last Thursday, leading drug makers announced a voluntary withdrawal of oral cough and cold medicines marketed for use in infants.

That move affected only infant oral medicines, not those intended and labeled for use in children aged 2 and older, Shannon noted.

Shannon, who filed the original petition with the FDA in March and was testifying at the hearings, doesn't think that last week's recall by manufacturers goes far enough. It only affects children under 2 and not children between 2 and 5, who make up two-thirds of those taking the drugs, he noted.

"They made an effort, but it was nowhere near far enough," Shannon said.

In addition, these cold products simply don't work, according to Shannon. "There is no reason to give something that costs money, is ineffective, and has potential risks," he said.

"One can question what their effectiveness is in older children and even adults," Shannon said. "Across all ages, the scientific evidence for their effectiveness is very weak and, for children under 6, the data are clear that they don't work."

Linda A. Suydam is president of the Consumer Healthcare Products Association (CHPA), which represents manufacturers of nonprescription medicines. In a statement, she said that, "The reason the makers of over-the-counter oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority."

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; Associated Press


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