By Rob Stein
Washington Post Staff Writer
Sunday, November 18, 2007
Sales of over-the-counter cold remedies for children have fallen sharply since a federal panel concluded they should not be used for children younger than 6 because of a dearth of evidence that they work and concerns they can be dangerous.
Even though the winter cold season has begun, sales of the products, which have been rising steadily for years, dropped more than 16 percent in the four weeks that ended Nov. 3, compared both with the previous four-week period and with the same period last year, according to the first estimates since the panel's Oct. 19 pronouncement.
"Historically, sales of these products are on an upswing at this time of year," said Jennifer C. Frighetto of ACNielsen, a market research firm that tracks the sales. "Based on the historical sales, one would have expected to see an increase, not a decrease."
Americans spent $21.1 million on the medications during the four weeks, the most recent period for which data is available, down from a little more than $25.3 million during the previous four weeks, the firm reported.
"This is good news," said Baltimore Health Commissioner Joshua M. Sharfstein, who is leading the drive to get the Food and Drug Administration to restrict use of the products. "This is a plus for child health. Fewer parents are giving unproven and potentially unsafe drugs to their children."
The pharmaceutical industry, however, maintains that the remedies are safe and effective, and said it is too soon to attribute the drop to the recent criticisms of them.
"It's premature to make the connection that a drop in sales is directly the result," said Elizabeth A. Funderburk of the Consumer Healthcare Products Association. "It's not surprising at this point to see that drop, given that it's been a mild cold season so far this year."
Several pediatricians disagreed, saying they had seen many parents in recent weeks who said they had stopped giving the medications to their children since hearing about the warnings.
"It really frightened a lot of parents," said Joanna Sexter of Spring Valley Pediatrics in the District. "Sometimes these stories come out, and parents challenge it and pooh-pooh it. This time, that didn't happen. I've had a lot of parents say they just threw it all away."
That was the case for Laura R. Moorer, a law librarian from Rockville. Even though she thinks the remedies have helped her 2 1/2 -year-old daughter, Katie, in the past, Moorer and her husband decided not to use any when she was hit by a bad cold several weeks ago.
"We kept her home from preschool and watched her spend several days in misery, and I felt bad we could not do something to alleviate the coughing and discomfort she was feeling," Moorer said. "But I was also concerned enough not to let her use the medication. So we went back to home remedies: elevated pillow, humidifier, steamy shower, not much milk, clear fluids and extra TLC."
Moorer said all of her friends have also sworn off the products, but some parents have not.
"We've used them for years. We think they're very safe," said Randy Tidd of McLean, noting that he and his wife still give the remedies to their 4-year-old son, Oscar, and 2-year-old daughter, Louisa, who was hit hard recently by a nasty cold.
"She wasn't sleeping or eating. Some days she would cough so much, she would throw up," Tidd said. "We gave her a dose recommended by the pediatrician, and she went from crying and fussing and not sleeping and not eating to within 15 to 20 minutes her symptoms disappearing. She took a huge nap and woke up much better. For both of our kids, the cause and effect is really crystal clear."
The controversy began when Sharfstein and others petitioned the FDA last spring to restrict use of the products, citing the lack of evidence that they work and reports of children suffering hallucinations, seizures, trouble breathing, heart problems and occasional deaths. The petition prompted the agency to convene a special panel of experts for a two-day hearing.
A week before the FDA panel met, major drugmakers voluntarily pulled all products for children younger than 2 but said the problems were overwhelmingly caused by parents inadvertently giving overdoses. But after an exhaustive review, the panel concluded there was little evidence the remedies worked for children younger than 12 and recommended they not be used at all in those younger than 6.
The industry, however, has vowed to keep the products on the market, saying they offer relief for older children as long as they are used according to directions. The companies are spending an estimated $50 million a year to sustain at least $300 million in annual sales, according AC Nielsen's figures, which do not include Wal-Mart.
The case illustrates the limits of the FDA's authority to regulate over-the-counter drugs. Although the agency is reviewing the advisory panel's recommendations, officials have said their ability to act quickly is restricted by the law.
In response, Sen. Edward M. Kennedy (D-Mass.) and Reps. Henry A. Waxman (D-Calif.) and Tom Allen (D-Maine) have introduced legislation that would give the agency power to pull such products from the market more easily.
"When American consumers buy OTC drugs, they expect them to be safe and to actually work," Waxman said in a statement. "If we don't get FDA the authority it needs to act quickly, Americans will continue to expose themselves to drugs that may not work, but may pose risks."
Sharfstein said he hopes the FDA will issue a statement advising against using the products as it initiates regulatory action.
"The companies are still aggressively promoting these products for young children," he said. "Unless the FDA makes a clear statement, the marketing is eventually going to drive consumption back up. I think the FDA should make a clear statement about what the science shows as they start whatever legal process is necessary to stop the marketing of these products for kids under age 6."
Officials said they are reviewing the situation. "FDA is in the process of developing the policy on this issue," said Charles Ganley, director of FDA's office of over-the-counter drugs.
Funderburk said the industry has launched an educational campaign aimed at helping parents use the medications more safely.
In the meantime, parents are making their own decisions. Tidd said many of his friends were still using the products.
"This is how we've been treating colds ever since they were born," said Tidd, adding that he and his wife are hoarding the bottles they have, anticipating that the remedies will eventually disappear from drugstore shelves. "We have a whole drawer full of the contraband, and we're holding onto it."