No cold medicines for children under 4, drug companies say

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

"The best thing a parent can do is comfort their children," said Dr. 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 kids 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 kids. And recent research has found some untoward side effects, mostly stemming from accidental overdoses.

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

"It's a huge step forward," said Dr. 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 some 7,000 children to hospital emergency rooms each year, with symptoms including hives, drowsiness and unsteady walking. Many kids overdose by taking medicines when their parents aren't looking.

"The 2- and 3-year-olds are definitely the highest risk," said Sharfstein. "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."

The new advice could create its own kind of quandary. For example, what to do in a family with a 3-year-old and a 6-year-old?

Dr. Herrera said parents should resist the urge to give the medications to the older child. "They feel like they're doing good by giving these medications, but in some cases they could be doing more harm than good," she said.

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