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Cold Meds Not Safe for Kids Under 2, FDA Warns
Date:1/17/2008

be safe by not giving medication that could potentially harm young children. It's the right thing to do."

Last November, the FDA became aware of a number of surveys that indicated that individuals or parents were continuing to use the products without getting advice from a health-care provider.

The medicines, which include decongestants, expectorants, antihistamines and cough suppressants, have been associated with different rare but serious events including convulsions, rapid heart rates, decreased levels of consciousness, and even death.

A review of records filed with the FDA between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine. Most of the deaths involved children younger than 2.

The current advisory is based on an agency review of data and recommendations discussed during a joint meeting of the Nonprescription Drugs and Pediatric Advisory committees last October. The committees recommended a ban on cold medicines in children under the age of 2.

Right before the meeting, makers of dozens of cough and cold remedies targeted to infants voluntary recalled these products. In particular, products with pictures of infants on the label or use of the word "infant" in the name were taken off shelves. Overall, there are approximately 800 popular cough and cold medicines sold in the United States. Experts estimate that Americans spend about $2 billion annually on these types of medications.

An internal working group at the FDA was not able to come to a consensus as to recommendations for children aged 2 to 11. A decision on this issue is expected by the spring.

Dr. Lisa Mathis, associate director of the FDA's Office of New Drugs, Pediatric and Maternal Hea
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