While CDER notes concerns about the safety of antacid/aspirin products, the Consumer Healthcare Products Association and other groups in the Acetaminophen Awareness Coalition point out safe use of OTC acetaminophen products has increased since FDA's 2009 rule added label warnings.

In a release from CHPA, the coalition said "data collected from the National Poison Data System and released in [September] 2015 show a steady decline in unintentional exposures of acetaminophen, including dosing errors and accidental misuse, since a peak in 2009."

The NPDS report, which was submitted to FDA, stated that exposures to acetaminophen-containing products decreased 24% from 171,951 in 2009 to 130,411 in 2013. The reports had increased 5.9% from 162,434 in 2007 to the peak in 2009 before beginning to slow.

NPDS also reported around 59% of acetaminophen-related exposures involved consumers 12 years old and up; and that exposures in all age groups have declined annually since 2009 – adults 20%, pediatric 29% and unknown age 39%.

CHPA also points out the coalition launched the Know Your Dose campaign in 2011 to educate consumers about safe acetaminophen use.

OTC Antacid/Aspirin Bleeding Risk Raises Concerns At CDER

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