Are OTC cold remedies safe for kids?

May 12, 2008

Toxicologists discuss whether OTC cough and cold remedies are safe for children to take.

Reports of children experiencing severe adverse reactions to over-the-counter cold remedies have grown in recent years. In the most tragic cases, the adverse reactions were fatal. The Food & Drug Administration addressed the problem last year. In August, the FDA published a health advisory warning parents about the potential hazards of OTC pediatric cold remedies. The FDA also tasked the Nonprescription Drugs Advisory Committee with addressing the safety of OTC cough and cold drugs for children.

Even if the drugs are safe, do they actually help alleviate cough and cold symptoms in children? Phillip D. Walson, M.D., professor of clinical pharmacology and director of clinical trials at Cincinnati Children's Hospital, said that all four classes of OTC cough and cold remedies (antihistamines, decongestants, cough suppressants, and expectorants) have been proven safe and effective in adults. On the other hand, Walson said, "Pediatric efficacy is clearly uncertain."

Walson did agree that extrapolation from adult doses isn't always accurate for pediatric doses, but he did not agree that extrapolation has no place in determining pediatric doses of OTC cough and cold medications. Extrapolation is needed, he said, but it is still not clear when extrapolation is justified. Both Walson and Snodgrass emphasized that more research is needed to determine whether OTC cough and cold drugs are effective in children and at which doses.

Research will take time, and parents need guidance now to prevent further deaths from OTC cold remedies. Manufacturers have responded to the issue by discontinuing the infant versions of their cough and cold products. The FDA has agreed that OTC cough and cold product use in children under two years old is too risky to warrant use. For now, the FDA will continue to allow these products to be available for use in children aged two to six.

Dart pointed out that most of the deaths related to cough and cold OTCs resulted from mistakes by parents or caregivers. Using the wrong measuring device, or no measuring device, was a common error. Another common mistake was drug duplication due to multiple products with the same ingredients being used. Duplication also occurred when more than one person administered the drugs. In some cases, children took the medications themselves. In other cases, the drugs were administered to sedate the children.

To prevent further deaths, parent education is crucial, Dart said. Improved measuring devices, clear labeling, simplified choices, and mechanical improvements to packaging are other potential solutions. And pharmacists can play a critical role by counseling parents on the proper use of OTC cold remedies.

THE AUTHOR is a writer based in the Seattle area.