(WASHINGTON, D.C.) — A newly published article in the medical journal Pediatrics concludes that over-the-counter (OTC) cough and cold medicines for children are safe when used and stored as directed. The article looks at a medication safety study that analyzed data collected from multiple national sources including the U.S. Food and Drug Administration (FDA) and involved more than 4,000 cases over five years. Researchers found that safety issues from children’s cough and cold medicines are very rare, occurring only 1 time per 1.75 million units sold, mostly due to accidental exposure or misuse. The article can be accessed online here.
For decades, OTC cough and cold medicines have been used by families and healthcare professionals to treat symptoms of upper respiratory infection in children. U.S. consumers spend over $5 billion annually on these products.
“This study shows that these medicines are safe for children,” according to William Banner, MD, a specialist in pediatric critical care and toxicology at Integris Baptist Medical Center in Oklahoma, and one of the authors of the journal article. “I believe that these medications work to relieve symptoms and help children feel better, and now this study shows that parents can also trust their safety. The study findings should also be a reminder to parents to store medicines up and away and out of sight to prevent accidental exposure.”
In 2007, a citizen petition was submitted to the FDA requesting more evidence behind the cough and cold treatments used in children, particularly related to children under age 6. In response, a new system was created to collect, analyze, and report any safety issues associated with cough and cold medicines. The Pediatric Cough and Cold Safety Surveillance System, funded by the Consumer Healthcare Products Association (CHPA), was designed to systematically collect information nationwide about any serious adverse events (AEs) associated with pediatric exposure to these medicines, and to determine possible causes or risk factors. The system tracked the eight most common active pharmaceutical ingredients found in cough and cold medicines: brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, pseudoephedrine, and phenylephrine.
For the safety study, researchers at the Rocky Mountain Poison & Drug Center (RMPDC) reviewed the past five years of surveillance system data looking for reported AEs associated with cough and cold medicines and further analyzed each AE to better understand the cause and outcome of each. Overall, they found that AEs from pediatric exposure to these medicines are uncommon, and that those that did occur were primarily due to accidental exposure in children less than 4 years old. Data showed only 1 AE per 1.75 million units sold (i.e. tablets, gelcaps, or liquid equivalent), with 67 percent occurring due to accidental unsupervised ingestion (AUI) of which 61 percent involved children between 2 and 4 years old. Other AEs were due to medication errors (13 percent), such as using the wrong dose, with 45 percent occurring among children between 6 and 12 years old.
“When OTC medicines are used as directed and labeled, they provide the efficacy and safety that consumers demand,” says Barbara Kochanowski, PhD, senior vice president for regulatory and scientific affairs at CHPA, the trade group that funded the study. “This study should be reassuring to healthcare professionals who recommend OTC medicines, parents who use them, and retailers who sell them. They each play a vital role in keeping children safe and healthy.”
Read more about this study and the journal article here. Learn about safe use of OTC cough and cold medicines at www.KnowYourOTCs.org. And find out how to store medications up and away and out of sight at www.UpAndAway.org.
(Article citation: Jody L. Green, George Sam Wang, Kate M. Reynolds, William Banner, G. Randall Bond, Ralph E. Kauffman, Robert B. Palmer, Ian M. Paul, Richard C. Dart, Pediatrics, May 2017, e20163070; DOI: 10.1542/peds.2016-3070)