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Research Highlights Risk for Acetaminophen Toxicity from Use of Over the Counter and Prescription Pain Medications

Review of published literature points to need for physician monitoring, awareness of patient overuse of acetaminophen

STAMFORD, Conn., April 4, 2014 /PRNewswire/ -- A review of published medical literature has found that individuals who receive pain relievers containing acetaminophen are commonly prescribed doses close to or above the U.S. Food & Drug Administration's (FDA) recommended daily maximum dose (4g per day), putting them at increased risk of acetaminophen overdose and liver toxicity. The research is being presented in a poster titled, "The Epidemiology of Opioid-Acetaminophen Combinations Exposure and Acetaminophen Toxicity in the United States" at the Academy of Managed Care Pharmacy's 26th Annual Meeting and Expo in Tampa, Fla.

Acetaminophen is a commonly used pain reliever that is available in over the counter products (Tylenol®) and prescription medications, where it is combined with opioid analgesics (i.e., fixed-dose combination products).  For example, acetaminophen in combination with the opioid hydrocodone (Vicodin® and its generic formulations) was the most prescribed medication in the U.S. each year from 2007 through 2011, according to a report by the IMS Institute of Healthcare Informatics.1 

Acetaminophen can cause liver toxicity (i.e., hepatotoxicity), including serious liver failure, when a patient exceeds the total recommended dosage of less than 4g per day.2

The literature review was performed to provide further insights into patient exposure to high-dose acetaminophen and the risk of overdose and related toxicity in the U.S. The literature review also found:

  • Each week, approximately 43 million adults in the U.S. take some form of acetaminophen.3
  • The average dose of acetaminophen in the prescriptions for opioid-acetaminophen combination products was 3.7g (standard deviation 34.5) per day.4 
  • Annually, acetaminophen overdose leads to nearly 80,000 emergency department visits and 30,000 hospitalizations, up to one-third of which are unintentionally induced.5 

Exposure to high doses of acetaminophen, alone or in combination with opioids, appears common in the U.S. despite the known risks of serious liver damage and death.  

"The literature review showed that unintentional overdoses are preventable and may be more likely to lead to acute liver damage than overdoses resulting from intentional self-harm," said Rami Ben-Joseph, Ph.D., Head of Health Outcomes and Pharmacoeconomics at Purdue Pharma, which funded the review. "Thus, when prescribing acetaminophen products, physicians should be aware of a patient's overall acetaminophen usage, through both prescription and OTC products containing acetaminophen." 

The complete literature review has been recently published online in the Expert Review of Clinical Pharmacology on March 28, 2014.

About Purdue Pharma L.P.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at

James Heins
Senior Director, Public Affairs
Office: 203-588-8069
Email: [email protected] 


1 IMS Institute for Healthcare Informatics. 2012. .   

2 Ferguson E, Nelson L. 2009. Silver Spring, MD: Food and Drug Administration. Accessed October 2013.

3 Lavonas EJ, Fries JF, Furst DE, et al. Comparative risks of non-prescription analgesics: a structured topic review and research priorities.  Expert Opin Drug Saf. 2012;11(1):33-44.

4 Duh MS, Vekeman F, Korves C, et al. Risk of hepatotoxicity-related hospitalizations among patients treated with opioid/acetaminophen combination prescription pain medications.  Pain Med. 2010;11(11):1718-1725.

5 Blieden M, Paramore L, Shah D, Ben-Joseph R. A perspective on the epidemiology of acetaminophen exposure and toxicity in the United States Read More:  



SOURCE Purdue Pharma L.P.

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