Study Shows Safety of Cough and Cold Medicines for Children

New research looked at five years of data involving more than 4,000

WASHINGTON–(BUSINESS WIRE)–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

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
And find out how to store medications up and away and out of sight at

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)

The Consumer Healthcare Products Association (CHPA) is the
136-year-old national trade association representing the leading
manufacturers and marketers of over-the-counter (OTC) medicines and
dietary supplements. Every dollar spent by consumers on OTC medicines
saves the U.S. healthcare system $6-$7, contributing a total of $102
billion in savings each year. CHPA is committed to empowering self-care
by preserving and expanding choice and availability of consumer
healthcare products.


Consumer Healthcare Products Association (CHPA)
Lauren Bloomberg,