FDA Panel Recommends Ban on Cold Medicines for Kids
Over-the-counter drugs are unsafe for children under 6, advisers say.
FRIDAY, Oct. 19, 2007 (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.
The evidence that the drugs work is "modest at best" even for adults, 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. The vote for additional testing of the drugs in children preceded the votes to ban the products.
The recommendations apply to medicines containing at least one 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.
"The recommendations may not lead to a ban of these products, but to a warning on the label," Dr. John K. Jenkins, the director of FDA's Office of New Drugs in the Center for Drug Evaluation and Research, said during a late Friday press conference.
"The message of the panel is that they haven't seen scientific evidence that these products work in children, and they were uneasy about extrapolating the adult doses for children. Parents should pay close attention to the directions on the label," he added.
"We need to take back to the agency all the advice we heard and decide what we are going to do," Jenkins said. "This has to go through the rule-making process, which can take some time."
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.
"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, before the hearings began Thursday.
"This recommendation is exactly what is needed to alert parents and policymakers about the erroneous labeling, marketing, and use of these products. Moreover, these medicines are ineffective and dangerous to young children," Bruce Lesley, president of the children's advocacy group First Focus, said in a statement released after the votes Friday.
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 week, 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 slated to testify 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.
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."
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.
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.
For more on cold remedies for children, visit the American Academy of Pediatrics.