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Warnings added to children's drugs

Bloomberg News / October 8, 2008
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WASHINGTON - Makers of over-the-counter cold and cough drugs added warnings against use in children younger than 4 years old after doctors and government advisers said the medicines are risky and may not work.

The industry's voluntary action stopped short of the ban in children under age 6 sought by pediatricians because the risk of overdose is greatest in 2- and 3-year-olds, said Linda Suydam, the president of the trade group Consumer Healthcare Products Association.

Pediatric antihistamines will also carry new labels telling parents not to use the medicines to sedate children of any age, the group said yesterday.

Outside advisers to the Food and Drug Administration recommended that such cough and cold drugs shouldn't be given to children younger than 6 and said there was no evidence they worked in those up to 12.

The new warnings will be added to products which will gradually replace drugs now on store shelves, Suydam said.

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