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Study Shows Decrease in Misuse of OTC Acetaminophen-Containing Combination Products

In a study newly published in the medical journal Clinical Toxicology, “therapeutic misuse” of over-the-counter (OTC) combination products containing acetaminophen was infrequent and declined over a 10-year period (from 2007-2016).

Researchers used the National Poison Data System (NPDS) to identify therapeutic misuse – when someone exceeds the maximum dose of an ingredient while using it for its intended purpose – involving acetaminophen-containing combination products in people 12 years or older between 2007–2016. Specifically, they found that therapeutic misuse exposures involving OTC acetaminophen-containing combination products decreased from 8,753 in 2007 to 6,278 in 2016, a 28 percent decline.Even with the reported decrease, study authors encourage continued consumer education about safe use of acetaminophen.

There is a growing body of evidence around the decrease in adverse events associated with OTC acetaminophen products. In a 2016 FDA study published in the journal Pharmacoepidemiology and Drug Safety, the rate of adverse events, poison center calls, and hospitalizations associated with acetaminophen products (single-use and combination products) overall decreased in recent years.

“When used as labeled and directed, acetaminophen is safe and effective,” said Barbara Kochanowski, PhD, senior vice president for regulatory and scientific affairs at the Consumer Healthcare Products Association (CHPA), the trade group that funded the Clinical Toxicology study. “This research provides reassuring evidence that incidents of misuse are rare and continue decreasing. But consumer education is key to continuing this downward trend.”

The CHPA Educational Foundation helps lead the Acetaminophen Awareness Coalition (AAC), a group of leading health, healthcare provider, and consumer organizations. The Coalition formed the Know Your Dosecampaign in 2011 to educate consumers about safe acetaminophen use in order to prevent unintentional overdoses.

“We remain committed to efforts aimed at reducing these incidents,” said Kochanowski. “In addition to our consumer education campaign, the OTC industry, in collaboration with FDA, provides clear packaging, labeling, dosing, directions, appropriate warnings, and education to help physicians and consumers who rely on these medicines.”

For more information about educational efforts and to see a list of the Acetaminophen Awareness Coalition members, visit

The Consumer Healthcare Products Association (CHPA) is the 137-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.

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Last Updated: 19-Oct-2018