WASHINGTON (AP) - 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,
"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
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
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
"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
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
-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.
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(Copyright 2008 by The Associated Press. All Rights Reserved.)