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Acetaminophen is the most commonly prescribed over-the-counter medication in the United States. Globally, 25 billion doses of acetaminophen or paracetamol, as it is known outside North America, are consumed annually. As a standalone medication and in combination with other drugs, acetaminophen falls into this category. Most acetaminophen available is over the counter. In addition to being a leading cause of acute liver failure in many countries, acetaminophen is also one of the leading causes of other health conditions.

Acetaminophen, also known as paracetamol, is dangerous to the liver at high doses, which was the challenge in this case. A cohort study involving 13,000 U.S. hospitalizations was conducted by Locke and co-authors. Following the FDA's mandate, researchers examined the difference between acetaminophen alone and acetaminophen when combined with opioids.

It has been reported that 43 percent of patients with acetaminophen-induced acute liver failure had acetaminophen combined with an opioid. The FDA imposed a restriction on the amount of acetaminophen permitted to be used by patients when taking combination medications containing acetaminophen and opioids in 2009, but the FDA did not ban these combinations. Prior to the FDA mandate, such medications contain acetaminophen.

Several factors limited the findings, including inconsistencies in coding for acetaminophen toxicity and opioid toxicity across geographical areas and time periods. This is according to the researchers. There were other limitations, such as the absence of codes for intravenous drug use in particular. Further, both fentanyl and acetaminophen-related hospitalizations may have been misclassified.

According to research, 40-58% of acute liver failure cases occur unintentionally and are caused by the use of acetaminophen and opioids. However, Babak J. Orandi, MD, PhD, of the University of Alabama, Birmingham, and colleagues have not examined the impact of the FDA mandate on these rates. He analyzed the data.

Different Studies With Different Results

• As a result of FDA regulations limiting acetaminophen in prescription products, acute liver failure hospitalizations declined significantly.

• According to the researchers, patients are often unaware that their products contain acetaminophen.

• An opioid user survey found almost half correctly identified products containing acetaminophen; another survey of general medicine patients found only 15% did.

• When taken with opioids or alone, acetaminophen increased alanine aminotransferase levels three times above normal. 

The most effective solution may ultimately be to prescribe pain medications that are safer and more effective. In reality, it is far from that. Acetaminophen continues to be the most popular drug throughout the world.