FDA Declares Cold Medicine Unsafe for Babies and Toddlers

January 2008

Urgent alert for parents of young children – several months after a panel of its experts voted to ban the selling of pediatric cold medicine, the Food and Drug Administration (FDA) has officially declared cold medicine unsafe for children under the age of two. Amid concerns that parents have not heeded last fall’s warning, the FDA has issued a public health advisory stating that the medicine carries life-threatening side effects for babies and toddlers.

Last year, the Centers for Disease Control reported that more than 1,500 babies and toddlers went to the emergency room during a two-year period as a result of over-the-counter (OTC) cold remedies. Additionally, there is no evidence that OTC cold medicine effectively treats cold symptoms in young children.

The next step will be determining the drugs’ safety for children under the age of 12. An internal FDA working group has been given a February deadline to propose a recommendation to agency leaders regarding the use of cold medicine for children ages 6 to 11. The FDA hopes to make an announcement on that recommendation in the spring.