14 Cold Remedies for Kids Removed: Studies Say the Popular Drugs Are Ineffective and Sometimes Dangerous for Those Under 2.
By Karl Stark, The Philadelphia Inquirer
Oct. 12–A group of drugmakers voluntarily removed 14 cough and cold medicines for infants from the market yesterday amid growing evidence that the popular drugs are ineffective and sometimes dangerous.
The recall, which covers only over-the-counter medicines for children under 2 years of age, means these drugs will no longer be sold for that age group. The affected drugs include the infant versions of such popular brands as Pediacare, Dimetapp and Tylenol.
Several experts said yesterday that the companies’ actions were laudable, but did not go far enough.
Common cough and cold medicines also fail to work in children under 6, said Joshua Sharfstein, Baltimore’s public health commissioner.
“Today’s announcement is a step in the right direction,” said Sharfstein, who is pushing the government to restrict the drugs. “More needs to happen. The regulations need to be solidified by the Food and Drug Administration.”
The recall comes a week before the FDA is scheduled to hold an advisory committee meeting to evaluate the safety and effectiveness of cough and cold medicines for children under 6.
Elizabeth Funderburk, spokeswoman for the Consumer Healthcare Products Association, an industry group, said the companies were not reacting to the forthcoming FDA hearing.
She said the industry, which includes Wyeth, of Madison, N.J., and McNeil Consumer Healthcare, of Fort Washington, had thoroughly studied the problem and noticed that most incidents of misuse occurred in children under 2.
“These medicines are extremely safe when used as directed,” she said.
They are also popular. Young children average six to 10 colds a year, studies show. And sales of cold remedies for children amounted to $311 million in the last year, excluding Wal-Mart Stores Inc., according to Nielsen Co. That was about 8 percent of the entire over-the-counter cough and cold market.
The 14 infant cold remedies voluntarily withdrawn yesterday were made by Wyeth, McNeil, Novartis AG and Vetco Inc., a unit of Prestige Brands Holdings Inc., of Irvington, N.Y.
Sharfstein said the industry was in a difficult position. Its advocates have submitted comments to the FDA suggesting that the drugs should not be used for very young children even while continuing to sell them for that age group.
“There was a real major inconsistency between their comments and what they were selling in the stores,” Sharfstein said. “It would not make sense to go into the advisory committee with that kind of discrepancy.”
Asked about those comments, Doug Petkus, a spokesman for Wyeth, which makes Robitussin, said “the company is going to go with an open mind” to the FDA hearing, and will most likely do what the government recommends. These drugs “have a long history of safety and efficacy in the adult population and children over the age of 2,” he added.
For more than a decade, public health experts and pediatricians have been pushing to limit the use of over-the-counter cold medicines for very young children, because studies show the drugs have little effect and in rare cases can lead to rapid heartbeats, difficulty breathing and even death.
Many cold products were allowed to be sold over the counter in the 1970s, and have not been closely studied in children, said Daniel Frattarelli, a Michigan pediatrician who investigated the issue for the American Academy of Pediatrics.
He said doses for children’s cold medicines were drawn from adult data and have been found in recent years to be incorrect.
“The evidence is very clear that these products don’t work in young children,” Frattarelli continued, adding that the data are less clear in older children and adults.
The American Academy of Pediatrics warned parents about the cold drugs’ lack of effectiveness and possible risks in 1997. In 2006, the American College of Chest Physicians said cough medicines should not be used in children under 14.
Sharfstein became interested in these drugs after the Baltimore medical examiner found that four children there had died over the last six years at least in part from overdoses of cold medicines.
Sharfstein convened a meeting of pediatric leaders in Baltimore, and they released a statement in October 2006 advising parents not to use the drugs for children under 5.
In March, the group filed a petition with the FDA, documenting that 123 young children had died from decongestants and antihistamines from 1969 to 2006, according to the FDA’s own reporting system.
Over the last five years, the FDA had also received reports of 401 adverse events involving children under 6 and cold medicines, the doctors said.
Other sources also indicated a problem. The Maryland poison control center received 1,100 calls in the last year for children under 5 who had ingested too much cough medicine.
Late last month, FDA safety experts recommended a range of new restrictions on the medicines, including that they not be used in young children.
Labels currently only ask parents to consult a doctor before giving the drugs to infants and toddlers.
Many parents do not understand that cough and cold products are generally variations of the same three active ingredients, so it is easy for babies to get a high dose, said Gary A. Emmett, who directs hospital pediatrics at Thomas Jefferson University Hospital in Philadelphia.
“I’ve never been very happy with cold medicines,” Emmett added. “I’ve never seen them be very effective.”
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Read the briefing documents for next week’s Food and Drug Administration meeting about children’s cold remedies at http://go.philly.com/health
Contact staff writer Karl Stark at 215-854-5363 or kstark@phillynews.com.
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