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"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.
On the Net:
Consumer Healthcare Products Association statement: http://tinyurl.com/4bzj2f
Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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