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No cold medicine for kids under 2: FDA

Agency warns of 'potentially life threatening side effects,' but sales impact on drugmakers is seen as limited.

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By Aaron Smith, CNNMoney.com

NEW YORK (CNNMoney.com) -- The U.S. Food and Drug Administration warned parents Thursday not to give over-the-counter cold medicine to children under age 2 because of "serious and potentially life-threatening side effects."

"The reality is these products are used quite a bit in this age group, and parents are using them without getting advice from a healthcare provider," said Dr. Charles Ganley, director of the FDA's Office of Nonprescription Drugs, in a teleconference with reporters.

Dr. Lisa Mathis, a new drug specialist in the FDA's Pediatric and Maternal Health Staff, said side effects could include convulsions, rapid heart rates, reduced consciousness or death.

The warning affects drugmakers Johnson & Johnson (JNJ, Fortune 500), Wyeth (WYE, Fortune 500) and Novartis (NVS) - but not by much, as over-the-counter medicine makes up just a sliver or those companies' sales.

For example, over-the-counter drugs make up less than one-tenth of Wyeth sales, and cold medicine for babies and toddlers make up a smaller fraction of that revenue.

Also, the warning was expected, as the Food and Drug Administration has been investigating the use of cold medicine in young children for some time. In October, FDA advisers voted 13-9 that cold medicine shouldn't be used in children under age 6.

"It reaffirms our voluntary recall in October," said Wyeth spokesman Doug Petkus. "We felt this was a way to reduce dosing errors and overdosing in children, who we felt were the most vulnerable."

Novartis also issued a statement that it supports the FDA action.

Les Funtleyder, analyst for Miller Tabak, said the sales impact on drugmakers is "limited."

"Higher-value drugs and medical devices are more meaningful to sales than cold medicine," said Funtleyder. "I think the more important issue here is not business, but public health."

The FDA said it was continuing to investigate the safety and effectiveness of over-the-counter cold medicine in children between the ages of 2 and 11. To top of page

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