Children’s Cold Remedy Sales Lagging After FDA Recommendation

CHICAGO _ Normally a season for rising sales of cold and cough remedies, particularly for kids, federal health advisers to the Food and Drug Administration appear to have put a cool compress on over-the-counter medication sales for children this fall.

A children’s cold remedy industry of more than $300 million in annual sales has been slowed in the last month, an industry market research firm said. The slowdown follows the withdrawal that began Oct. 11 by makers of cough and cold remedies who pulled their products for children under the age of 2, citing the potential for misuse.

One week later, an FDA advisory panel said children ages 2 to 6 should not use cough and cold medicines such as antitussives, decongestants and antihistamines because their effectiveness has not been studied in kids and the risks outweigh their benefits.

The mounting pressure on the cough and cold medicine industry appears to be taking its toll. Unit volume sales of children’s over-the-counter cold remedies were down 0.3 percent for the 10-week period ending Oct. 20 to 9.16 million, while sales are up a little less than 1 percent to $54 million through Oct. 20, a day after the FDA panel made its recommendation, according to marketing information from The Nielsen Company.

By comparison, dollar sales and unit sales were up 14 percent and 12 percent, respectively, during the same period from 2005 to 2006, Nielsen figures show.

“Parents who rely on cough and cold medicines are expressing frustration,” said Melissa Davies, research director for Nielsen Company subsidiary Nielsen Online, which monitors consumer attitudes on blogs and other discussions on the Internet. “There were a lot of fence sitters who wondered whether this stuff worked who have been swayed (not to use cough and cold medicines for their children.)”

The danger in taking over-the-counter cough and cold medicines comes from a high dosage or combination of medicines given in a short period of time. Doctors say problems tend to occur when parents give a child one brand that ends up not working and then try something else.

The FDA still has to act on the panel’s recommendations that such products not be used for children under the age of six, so retailers have kept the products on their shelves with increased signage about potential risks.

“We did post signs in the cough and cold section that did say that we urge customers to consult with their physicians before using any cough and cold medicine products for children under six,” said Michael Polzin, spokesman for drugstore giant Walgreen Co., which operates more than 6,000 stores in 49 U.S. states.

Walgreens, while declining to provide specifics for its stores, said sales of cough and cold remedies slowed in part because of product withdrawals and FDA panel scrutiny. But the Deerfield, Ill.-based pharmacy chain is not ready to concede it is entirely due to pressure from the regulatory cloud hanging over the products use in children under than age of 6.

Walgreens said the cold and flu season, in particular, has not hit yet because of warmer fall weather than normal across the country. “There is still a lot of time for flu,” Polzin said.

But doctors say the publicity turning consumers away from over-the-counter medicines is a good thing.

“I find that less people are asking me about what they should do when their child has a cold,” said Dr. Joel Schwab, associate professor of pediatrics at the University of Chicago. “You don’t have to go out at 1 a.m. … and get something that is expensive that may not work anyway, so this is good news that fewer people are using them.”

Some pediatricians and advisers on the FDA panel said last month that there is no evidence that they should be used for older children up to 12 because of the lack of studies. Some studies that have looked at over-the-counter cold and cough medicines in adults questioned their effectiveness.

More than 800 over-the-counter cough and cold products are sold in the United States, the FDA said. Sales of cold and cough products are estimated at more than $3.7 billion annually, including more than $311 million in children’s cold remedies, according to Nielsen Co.

Doctors advise parents to consult with their physicians and use acetaminophen, ibuprofen or saline nose drops for relief. For coughs in particular, elevate the child’s head with pillows at bedtime, run a humidifier and give her a lot of fluids.

Doctor groups, including the American Academy of Pediatrics, have voiced concern about the risks of cold and cough medicines for at least a decade. In 1997, for example, the academy warned about overdose potential and other risks with certain cough suppressants.

In January, the U.S. Centers for Disease Control and Prevention published a study of hospital emergency departments that found more than 1,500 children younger than 2 were treated for “adverse events, including overdoses, associated with cough and cold medications.” The report identified three deaths. The CDC study cited cough and cold medicines that contain nasal decongestants, antihistamines and cough suppressants, among other remedies.

In August, the FDA issued a health advisory that the public “not use cough and cold products in children under 2 years of age unless given specific directions to do so by a health-care provider.”

But the over-the-counter medication industry, which includes Johnson & Johnson, Wyeth and Novartis AG, is standing by its products. An industry spokesman said the products are safe as long as parents closely follow the directions on the product labels and consult with their physicians before using.

Nielsen Online’s Davies said consumers have been dismayed that some other parents are not reading labels in the first place and are frustrated about the products withdrawal for children under the age of 2. They believe parents should still have a choice in what to give their child.

“Some feel that just because some parents cannot practice common sense, then all of us are being punished,” Davies said.

___

(c) 2007, Chicago Tribune.

Visit the Chicago Tribune on the Internet at http://www.chicagotribune.com/

Distributed by McClatchy-Tribune Information Services.

For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.