Researchers from Boston University's Slone Epidemiology Center have found that exposure to pseudoephedrine, a decongestant found in many cough-and-cold and allergy medications, has been common among U.S. children, especially those under the age of two years who are at the highest risk for toxicity and for whom safe dosing recommendations are lacking.
These findings appear in the December issue of the journal Pediatrics .
Pseudoephedrine has been associated with deaths and adverse events in young children. However, the absolute risks of pediatric pseudoephedrine use are difficult to determine because the number of children exposed to this medication and typical patterns of use are unknown. In addition, use may be changing because of the Combat Methamphetamine Act of 2005, a law which limited availability of pseudoephedrine-containing products.
To define the frequency and patterns of use, the researchers analyzed data from 1999 through 2006 on pseudoephedrine use among 4,267 children, aged 0 to 17 years, who were enrolled in the Slone Survey, a national random-digit-dial telephone survey of medication use in the U.S.
The researchers found 4.9 percent of children took pseudoephedrine in a given week. Use was highest in children under two years of age (8.1 percent). Sixteen children (7.5 percent of users) took more than one pseudoephedrine-containing product within the same week, including six children under two years old. Of the pseudoephedrine products used, most were multiple-ingredient liquids (58.9 percent) and multiple-ingredient tablets (24.7 percent). Fifty-two subjects (25 percent of users) took pseudoephedrine for longer than one week, including seven children under two years of age. Perhaps reflecting reduced availability, use in 2006 (2.9 percent) was significantly lower than in 1999-2005 (5.2 percent).
Concerning patterns of use identified in the study include taking more than one pseudoephedrine-containing product at the same time and using pseudoephedrine for long periods of time. Pediatric pseudoephedrine use appears to be declining since the institution of the 2005 Combat Methamphetamine Act. "Pseudoephedrine exposure, mostly in the form of multiple-ingredient products, is common among U.S. children and needs to be monitored closely because of the potential for this medication to cause harm, particularly to children under two" said lead author Louis Vernacchio, MD, MSc, an assistant professor of epidemiology and pediatrics at Boston University School of Medicine.