150 Americans Overdose on Acetaminophen Every Year
A recent investigation conducted by the non-profit publication ProPublica raises questions on if and how the U.S. Food and Drug Administration (FDA) should regulate access to acetaminophen due to risks of overdose leading to liver failure and death.
ProPublica Investigates the History and the Dangers of Acetaminophen
- Acetaminophen is a common pain reliever found in both prescription medications and over-the-counter drugs including Tylenol.
- Approximately 29 billion doses of acetaminophen were taken by Americans in 2009, but ProPublica claims that 25 percent of Americans take more than the recommended dose, unaware of the potential risks.
- While acetaminophen is normally portrayed as a safe drug with Tylenol being advertised as providing “safe, fast pain relief,” ProPublica argues that it is this very portrayal that leads to lax use of the drug and accidental overdose.
- The truth of the drug is that simply taking 25 percent more than the maximum recommended dose (2 additional extra-strength pills in a day) can result in acute liver failure.
Acetaminophen Overdose Statistics
- According to ProPublica’s investigation, from 2001 to 2010, more than 15,000 people have died as the result of accidental acetaminophen overdose, approximately 150 accidental deaths every year.
- This is about double the number of deaths attributed to all other over the counter pain relievers combined during the same time period.
- In 2010 alone, 321 people died as the result of acetaminophen overdose with 166 being ruled accidental. The other 155 were considered to be suicide or overdose due to unknown intentions.
- It is also estimated that acetaminophen overdose leads to 78,000 emergency room visits and 33,000 people being hospitalized annually.
Should the FDA Regulate Acetaminophen More Strictly?
“The 4 gram per day recommended dose is also the maximum safe dose, one that must not be exceeded, an unusual situation for any drug, particularly an OTC drug, one placing a large fraction of users close to a toxic dose in the ordinary course of use.” – FDA Committee Report
- These dangers are not lost on the FDA. In fact, prescription drugs containing acetaminophen already include a black box warning label addressing risks of liver transplant and death.
- The FDA not only acknowledges that over-the-counter acetaminophen like Tylenol can easily lead to overdose, but even proper use can lead to stomach bleeding and deadly skin rashes.
- In a number of other countries, including Great Britain, regulators have either limited the amount of acetaminophen a person can buy at one time or require that the drug only be sold at pharmacies.
- With all this in mind, the question remains: Why does the FDA not regulate acetaminophen?
- The current answer the FDA gives is that though the agency considers acetaminophen to be a top priority, “It just takes time.”
- Acetaminophen has been on the market in the United States since 1950. A recommendation for an “obligatory” warning label acknowledging the risk of overdose and liver failure from over-the-counter acetaminophen like Tylenol was made in 1977.
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