MEDICATIONS: CAUTION URGED IN USE OF OVER-THE-COUNTER COUGH AND COLD MEDICINES

January 17, 2008 — The U.S. Food and Drug Administration today issued an advisory strongly recommending that over-the-counter cough and cold medications not be given to infants and children younger than 2 years of age because of the risk of life-threatening side effects. The American Academy of Pediatrics (AAP) supports this recommendation and urges parents to seek safer ways to soothe infants and young children suffering from colds and coughs.

Studies have shown cough and cold products are ineffective in treating symptoms of children younger than 6 years old, and may pose serious risks. A variety of rare, serious health problems have been associated with use of these medications in children, including death, convulsions, rapid heart rates and decreased levels of consciousness

"It is critically important for parents to receive clear information about the risks and lack of benefit from these drugs, and ways to help take care of children suffering from colds and coughs," said Renee Jenkins, M.D., FAAP, president of the American Academy of Pediatrics. "We urge FDA to continue its analysis of the existing data on these medicines intended for children older than age 2 and take appropriate action, including initiation of immediate, rigorous scientific studies as needed to determine the drugs' safety and efficacy."

Children metabolize and react to medications differently than adults, often in unanticipated ways. For more than 30 years the AAP has emphasized the importance of studying medicines in pediatric populations. As part of the FDA's ongoing review of over-the-counter cough and cold medications, the AAP in October urged regulators to pursue further studies into whether these drugs have any benefit to children. The AAP also advised labeling that would inform parents that the products have been shown to be ineffective in children younger than 6 and could lead to serious adverse reactions. Thursday's advisory is an important first step. The FDA expects to announce its recommendation for children ages 2 to 11 in early spring.

While annoying, cough and cold symptoms are usually benign and self-limiting. Over-the-counter cough and cold medications will not cure these illnesses nor shorten their duration. Parents should seek safer ways to nurse their children back to health, Dr. Jenkins said.

"Although these medications have been in use for a long time, now we've learned they have some risks, especially because of the difficulty in determining a safe and accurate dose for small children," Dr. Jenkins said. "Instead of drugs, there are symptomatic interventions parents can do that are much safer for children."

Dr. Jenkins recommended saline nose drops and suctioning bulbs to thin and clear mucus from a baby's nose, and using a cool-mist humidifier. Chest physical therapy can also loosen mucus and may help infants and young children expel mucus. If a child younger than age 2 develops a fever, consult a pediatrician.