Liver Failure Linked To Tylenol/Acetaminophen

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Liver Failure Linked ToTylenol/Acetaminophen

By n Neergaard 12-28-5

Accidental poisonings from the nation's most popular pain reliever seem to be rising, making acetaminophen the leading cause of acute liver failure. Use it correctly and acetaminophen, best known by the Tylenol brand, lives up to its reputation as one of the safest painkillers. It's taken by about 100 million people a year, and liver damage occurs in only a small fraction of users. But it's damage, often avoidable, that can kill or require a liver transplant. The problem comes when people don't follow dosing instructions -- or unwittingly take too much, not realizing acetaminophen is in hundreds of products, from the over-the-counter remedies Theraflu and Excedrin to the prescription narcotics Vicodin and Percocet. "The argument that it's the safest sort of has overruled the idea that people cannot take any amount they feel like," said Dr. Lee of the University of Texas Southwestern Medical Center. Acetaminophen bottles recommend that adults take no more than 4,000 milligrams a day, or eight extra-strength pills. Just a doubling of the maximum daily dose can be enough to kill, warns Dr. Anne Larson of the University of Washington Medical Center. The Food and Drug Administration has long wrestled with the liver risk, warning two years ago that more than 56,000 emergency-room visits a year are because of acetaminophen overdoses and that 100 people die annually from unintentionally taking too much. A study published this month by Drs. Larson and Lee has agency officials weighing whether to revisit the issue. In a six-year span, researchers tracked 662 consecutive patients in acute liver failure who were treated at 22 transplant centers. (Acute liver failure is the most severe type, developing over days, unlike chronic liver failure that can simmer for years because of alcohol abuse or viral hepatitis.) Almost half were acetaminophen-related. More remarkable was the steady increase: Acetaminophen was to blame for 28 percent of the liver poisonings in 1998, and jumped to 51 percent of cases in 2003. That makes acetaminophen the most common cause of acute liver failure, the researchers report in the journal Hepatology.

Nearly half of the cases were related to unintentional overdoses of acetaminophen, which "isn't hard to do," Dr. Larson said. Say you take Tylenol Cold & Flu Severe for the flu's aches and stuffiness -- 1,000 milligrams of acetaminophen, every six hours. A headache still nags so between doses you pop some Excedrin -- 500 mg more of acetaminophen. Switch to Nyquil Cold/Flu at bedtime, another 1,000 mg. Maybe you already use arthritis-strength acetaminophen for sore joints -- average dose 1,300 mg. Depending on how often they're taken, the total acetaminophen can add up fast. That's the nonprescription realm. Surprisingly, 63 percent of unintentional overdoses involved narcotics like Vicodin and Percocet that contain from 325 mg to 750 mg of acetaminophen inside each pill.

http://www.washingtontimes.com/national/20051227-124950-9535r.htm

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Rise in Liver Failure Linked to Tylenol Overdoses

Thursday, December 01, 2005

By Miranda HittiTaken properly, Tylenol (acetaminophen) is a safe painkiller. But taking too much Tylenol can lead to liver failure. That overdose risk is well-known and noted on Tylenol’s label. Now, a new study shows a rise in cases of acute (sudden) liver failure reportedly linked to Tylenol overdoses.

The researchers included Anne Larson, MD, an assistant professor of medicine at the University of Washington.

Their report, published in Hepatology, states that the maximum recommended daily dose of acetaminophen is 4 grams.

Check the labels of any over-the-counter drugs you’re taking to see how much acetaminophen each pill contains and read up on the products’ warnings. If you suspect an overdose, get medical help or contact a poison-control center immediately. The sooner treatment can be initiated in an acetaminophen overdose, the better the chances for recovery and survival.

Latest Study

Larsen and colleagues studied six years of data from 22 university medical centers. During that time, 662 patients met the reseachers’ criteria for acute liver failure.

The researchers determined that a little less than half of those cases (42 percent, or 275 people) were linked to acetaminophen overdoses.

Over the years, acetaminophen accounted for increasing percentages of the cases.

“The annual percentage of acetaminophen-related acute liver failure rose during the study from 28 percent in 1998 to 51 percent in 2003,” write the researchers

On average, patients had taken 24 grams of acetaminophen. That’s six times the maximum daily dose of 4 grams, or the equivalent of 48 extra-strength tablets.

Intentional Overdoses?

Larsen’s team tried to determine whether patients overdosed on purpose and what (if any) other drugs they had also taken.

Figuring that out wasn’t always easy, given the patients’ condition. The researchers concluded that 44 percent of the patients had deliberately overdosed in suicide attempts and 48 percent had overdosed unintentionally. Patients’ intentions weren’t clear in 8% of the cases, the study shows.

Here’s how the patients fared:

--65 percent survived (175 people)

--27 percent died without getting a liver transplant (74 people)

--8 percent got liver transplants (23 people)

Many patients (65 percent) who reported exceeding acetaminophen’s daily limit also abused alcohol, which can damage the liver, the researchers note. They add that some patients were also depressed.

Accidental Overdoses

The patients who unintentionally took too much Tylenol had some things in common.

More than a third (38 percent) simultaneously took at least two products containing acetaminophen. An example might be a combination medication such as Sudafed Severe Cold or Tylenol Cold & Flu.

Tylenol’s web site tells patients taking more than one over-the-counter medication to check the products’ active ingredients.

“Do not take two medicines with the same active ingredient at the same time unless instructed to do so by your doctor, pharmacist, or other healthcare professional,” states Tylenol’s web site.

In addition, nearly two-thirds of the patients who unintentionally overdosed were also taking drugs containing narcotics, the study shows. Some commonly prescribed narcotic medications containing acetaminophen include Percocet, Vicodin, and Lortab.

Most patients (79 percent) said they were taking the medication(s) for pain relief.

Researchers’ Conclusions

The FDA predicts 458 deaths per year in the U.S. from acetaminophen-related acute liver failure, note Larsen and colleagues.

They suggest more education for doctors, pharmacists, and consumers about avoiding acetaminophen overdoses.

Second Opinion

An editorial in the journal notes that the study broadly defined acetaminophen-related acute liver failure.

“The adoption of these broader criteria almost certainly resulted in the inclusion of some cases that were not truly related to acetaminophen,” writes editorialist O’Grady, MD, FRCPI.

O’Grady didn’t work on Larsen’s study. He’s a hepatologist (liver specialist) with the Institute of Liver Studies at King’s College Hospital in London.

O’Grady adds that the patients’ liver tissue wasn’t examined. Still, he states that the study “establishes the need for greater circumspection with regard to the possible role of acetaminophen in the causation of liver failure.”

O’Grady predicts “potential benefits” from educational initiatives about safe use of acetaminophen.

He also notes that “huge numbers of patients [take] acetaminophen with good effects and in the absence of any adverse event.”

By Miranda Hitti, reviewed by Louise Chang, MD

SOURCES: Larsen, A. Hepatology, December 2005; vol 42: pp 1364-1372. WebMD Medical News: “Tylenol Safety Debated -- Again.” Tylenol.com: “How to Read a Drug Facts Label.” O’Grady, J. Hepatology, December 2005; vol 42: pp 1252-1254.http://www.foxnews.com/story/0,2933,177342,00.html