Is Your Child's Cough and Cold Medicine Safe?

October 2007

UPDATED ALERT – The Food and Drug Administration (FDA) held a panel to discuss the safety of children’s over-the-counter cold and cough medications. The panel composed of medical experts voted 21 to one to ban pediatric cold products in children less than two years of age. The vote for a ban against child cold drugs for children from two- to five-years-old was 13 to nine.

Although the FDA usually follows the advice of medical panels, a closer vote means that the agency may not follow the recommendations of its experts. Many manufacturers and trade groups believe that the FDA will not take kids’ cold and cough medicines off the market.

ORIGINAL ALERT – Parents – do you know how safe your children’s cold medicine is? Safety experts with the Food and Drug Administration (FDA) have asked the government agency to consider a complete ban of all over-the-counter cough and cold medication for children under six.

This includes brands such as Toddler’s Dimetapp, Triaminic Infant, and Little Colds. Around 800 similar cold and cough medicines are marketed to infants and young children in the United States. The Centers for Disease Control and Prevention found that between 2004 and 2005 over 1,500 children under two-years-old suffered health problems after using cold and cough medicine. The American Academy of Pediatrics has recommended that child cold and cough medicine labels note that such medications have been found to be ineffective in children under six and have caused adverse events, including death.

The FDA has also ordered manufacturers to cease production on over 200 unapproved prescription pain and cough medication containing hydrocodone. The drug is a narcotic only approved for use in seven different medications. Unapproved children’s medicine with hydrocodone must end production by October 31, 2007, while non-children’s products must end by December 31, 2007.