How many people in the United States die or suffer serious harm from acetaminophen overdose?
To try to answer this question, ProPublica examined three sets of primary data, as well as dozens of scientific studies. While the data sets varied on the total number of deaths, all three showed an increase in acetaminophen-linked fatalities over much of the past decade, with only occasional year-to-year declines.
Here is an in-depth look at the numbers.
Data compiled by the U.S. Food and Drug Administration has linked as many as 980 deaths in a year to drugs containing acetaminophen. In addition, FDA reports of death associated with acetaminophen have been increasing faster than those for aspirin, ibuprofen and many other common over-the-counter pain medicines.
Data obtained from the U.S. Centers for Disease Control and Prevention show that more than 300 people die annually as a result of acetaminophen poisoning.
Beginning in 2006, according to the CDC, the number of people who died after accidentally taking too much acetaminophen surpassed the number who died from intentionally overdosing to commit suicide.
The American Association of Poison Control Centers (AAPCC), a nonprofit that receives federal funds, shows about 113 people dying each year as a result of overdosing on medicines with acetaminophen. Since 2006, acetaminophen has accounted for more fatalities than all other over-the-counter pain relievers combined, according to AAPCC data.
Why the large differences? Because each organization’s data has strengths and weaknesses.
The FDA relies primarily on individual case reports, called FDA Adverse Event Reports, submitted by drug makers, consumers and doctors. Drug makers must submit information about any cases they learn about involving side effects linked to their drugs, while reports by consumers and healthcare workers are voluntary. The reports often lack key information. By some estimates, the FDA system captures from 1 percent to 10 percent of adverse events involving drugs.