No cough or cold medicine for kids under 4, firms say

WASHINGTON - Don't give over-the-counter cold remedies to children under 4, drug companies said yesterday. What sniffling little ones need, doctors said, are plenty of fluids and loving care.

"The best thing a parent can do is comfort their children," said Laura Herrera, a Baltimore family practitioner and mother of two. "Keeping them as comfortable as possible is certainly better than giving cough and cold medicines."

In a concession to pediatricians, who doubt the drugs do much good for children and worry about risks, the companies that make over-the-counter remedies like Dimetapp and Pediacare announced they had changed their advice to parents for the second cold season in a row.

Besides recommending against cold medicines off drugstore and grocery shelves, the companies say not to give antihistamines to kids to help them sleep. The new instructions are on packages that started hitting stores this week.

Last year, the industry went against cough and cold medicines for children under 2. The latest changes came after discussions between drug companies and the Food and Drug Administration. The talks were kept quiet for months as federal health officials debated how to respond to a pediatricians' petition seeking to ban the medications for children under 6.

At a public hearing last week, neither industry officials nor regulators gave any hint of an impending announcement.

Cough and cold products have been given to children for decades, but it turns out the medicines were never scientifically tested to see how well they work in children. And recent research has found some untoward side effects, such as accidental overdoses.

Pediatricians who support a ban for children under 6 nonetheless said they were pleased with the industry announcement.

"It's a huge step forward," said Joshua Sharfstein, Baltimore's health commissioner. "There is no evidence that these products work in kids, and there is definitely evidence of serious side effects."

Problems with over-the-counter cough and cold medicines send 7,000 children to emergency rooms each year, with symptoms including hives, drowsiness and unsteady walking. Many children overdose by taking medicines when their parents are not looking.

"The 2- and 3-year-olds are definitely the highest risk," Sharfstein said. "More than 50 percent of the problem is with these kids. If they don't have this stuff around the home, they're less likely to grab it and ingest it."