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.
Herrera has a 6-year-old daughter and 7-year-old son, and neither of them have gotten cold remedies.
The drug makers said they are also introducing new dispensers to help parents make sure they give the right amount of medicines, and not too much. The industry is expanding a nationwide educational campaign aimed at getting parents to be more careful.
"We are doing this voluntarily out of an abundance of caution," Linda Suydam, president of the Consumer Healthcare Products Association, said in announcing the changes on behalf of the companies. "The vast majority of the serious adverse events are in 2- to 3-year-olds. They are the ones who get into the products by being curious toddlers."
Sen. Christopher Dodd, D-Conn., an advocate for children's health care, said he will continue to press the FDA to ban the drugs for children under 6. Outside advisers made that recommendation to the agency a year ago.
"While I'm pleased to see that the drug companies are voluntarily taking some steps to ensure the safety and well being of our children, I am disappointed that the FDA has not followed the recommendations of its own advisory panel," Dodd said.
Dr. Janet Woodcock, a senior FDA official, said restricting use of the medicines to children over 4 makes sense as an interim step, while the agency continues to study the risks and benefits in children under 12. It's a process that could take years.
"This was a logical cutoff," said Woodcock, adding, "It was somewhat of a judgment call." She said government officials fear that taking the medicines off the shelves might prompt parents to give their children adult medicines instead.
Leading cough and cold brands include Dimetapp, Pediacare, Robitussin, Triaminic, Little Colds and versions of Tylenol that have ingredients to treat cold symptoms. U.S. families spend at least $287 million a year on cold remedies for kids, according to Nielsen Co. statistics that do not include Wal-Mart sales.
Herrera, the Baltimore family doctor, said kids with colds usually get better in a few days. Coughs and sniffles can be distressing, but they are also a sign that the body is doing its work.
Parents may want to give Tylenol or Motrin if a child is running a fever of 101 degrees or higher, Herrera said. Sniffles can be cleaned up with tissues or gently suctioned if kids are too young to blow their noses. And children should be watched for any signs of trouble breathing, which could signal more serious problems.
The industry said parents should never:
_Give adult medicines to a child.
_Give two or more medicines with the same ingredients at the same time.
_Give antihistamines to make a child sleepy.
And parents should:
_Give the exact recommended dose, using the measuring device that comes with the medicine.
_Keep medicines out of sight and out of reach.
_Consult their doctors if they have any questions.