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FDA Warns: Cold and Cough Medicine Unsafe for Infants and Toddlers


Finally acting on last fall’s huge voluntary recall by most manufacturers of cold and cough medicine, the Food and Drug Administration warned today that giving over-the-counter cough and cold medicine to children under the age of 2 could potentially kill the child.

After studying the issue for months and noting that more than 1,000 infants and toddlers have been taken to emergency rooms after having serious reactions to cold medicine and cough syrup given to them by a caregiver, the FDA concluded that the use of these products in children under the age of 2 could lead to “serious and potentially life-threatening” side effects.

Over the past 27 years, more than one hundred and twenty children have died after using decongestants and antihistamines. The warning comes from the FDA because of concerns that parents and caregivers were still not heeding the advice against use with infants and toddlers, despite extensive publicity in October, 2007.

Experts caution that these medicines do nothing to lessen the duration or severity of a cold; they merely address the symptoms. “Remember that these medicines do not cure the cold. They do not shorten time your child has a cold, and they’re only meant to help a child’s symptoms,” said Dr. Lisa Mathis, the associate director for the FDA’s Office of New Drugs, Pediatric and Maternal Health Staff. For treating colds in infants and children under 2, the American Academy of Pediatrics recommends old-fashioned remedies, including plenty of fluids, rest, as well as saline drops and rubber nose bulbs to ease stuffy noses.

In addition, the issue whether further warnings should be issued for older children remains unresolved. Despite hearing overwhelming support for further admonitions against their use in children under 12, the FDA has yet to act. However, the FDA is expected to address the issue and reach a decision in the coming months.

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