FDA warns about using OTC cough, cold meds on young kids

Products don't seem effective for preschoolers and may have negative consequences.

By Victoria Stagg Elliott, AMNews staff. Sept. 10, 2007.

When Nashville, Tenn., pediatrician Joseph Gigante, MD, speaks with parents seeking remedies for their sniffling, sneezing and coughing infants or toddlers, he asks them what they've tried so far. They often will list a number of over-the-counter cough syrups, decongestants and combination products that are marketed for use in children. They also often complain that the preparations haven't worked. He views such instances as chances to steer them toward approaches that may be more effective with less risk, such as increased fluid intake.

"Parents spend a lot of money on these products, but they don't make a lot of difference," said Dr. Gigante, associate professor of pediatrics at Vanderbilt Children's Hospital.

Pediatric cough and cold remedies have been on store shelves for a long time, with the expectation that efficacy could be extrapolated from adult studies, dosages could be calculated and safety profiles would be similar. But definitive evidence about their use for young patients has been lacking. And, in light of reports of kids being harmed by these products, physicians and regulatory agencies are questioning whether they should be used.

Last month, the Food and Drug Administration charged its Nonprescription Drugs and Pediatric Advisory Committees to discuss at an Oct. 18-19 meeting the use of antitussives, expectorants, nasal decongestants, antihistamines, and various combination cough and cold products by children younger than 11. The FDA also issued a public health advisory that these products should not be used in children younger than 2 unless advised by a physician or other health care professional. It also warns that overdoses could be life-threatening.