The Associated Press reports that high doses of Tylenol (acetaminiphen) the most popular over the counter painkiller caused abnormal liver test results
in healthy adults within two weeks "raising concerns that even recommended amounts of the popular painkiller might lead to liver damage."
In a controlled study published in the Journal of the American Medical Association, the people who took placebos experienced no alarming liver test
"But nearly 40 percent of people in all the other groups had abnormal test results that would signal liver damage"
Furthermore, in clinical practice, "Overdoses of acetaminophen are the leading cause of acute liver failure."
One of our own knowledgable experts commented as follows:
" We learned in our pharmacology classes 30 years ago that acetaminophen caused liver damage and that people who took a bottle in a "cry for help",
unlike those taking aspirin, would die from liver failure. FDA has done little, and now everyone acts as though this is a big surprise."
(the informer prefers to remain anonymous only to protect employment).
Contact: Vera Hassner Sharav
THE NEW YORK TIMES
July 4, 2006
High Tylenol Doses Linked to Liver Woes
By THE ASSOCIATED PRESS
CHICAGO (AP) — Healthy adults taking maximum doses of Tylenol for two weeks
had abnormal liver test results in a small study, researchers found, raising
concerns that even recommended amounts of the popular painkiller might lead
to liver damage.
In the study, 106 participants took four grams of Tylenol — equivalent to
eight extra-strength Tylenol tablets — each day for two weeks. Some took
Tylenol alone and some took it with an opioid painkiller. Dummy pills were
given to 39 others.
There were no alarming liver test results among the people who took the
placebos. But nearly 40 percent of people in all the other groups had
abnormal test results that would signal liver damage, according to the study
that appears in Wednesday’s Journal of the American Medical Association
”I would urge the public not to exceed four grams a day. This is a drug
that has a rather narrow safety window,” said a study co-author, Dr. Neil
Kaplowitz of the University of Southern California
Heavy drinkers should take no more than two grams daily, Kaplowitz said.
Another co-author, Dr. Paul Watkins of the University of North Carolina said
he’s less worried than Kaplowitz, noting that acetaminophen, the active
ingredient in Tylenol, has been used for 50 years and has a good safety
The maker of Tylenol, McNeil Consumer & Specialty Pharmaceuticals , said its
own research found much lower rates of abnormal liver results. The company’s
studies tracked high-dose users over longer periods than did the new study.
”It doesn’t lead to liver disease and it usually resolves as patients
continue to take acetaminophen,” said Dr. Edwin Kuffner, senior director of
medical affairs at McNeil.
The researchers had been hired by the drug company Purdue Pharma LP, maker
of the prescription painkiller OxyContin, to find out why abnormal liver
tests were showing up in people testing a combination drug containing the
acetaminophen and the opiate hydrocodone.
Purdue Pharma stopped its hydrocodone study early because of the abnormal
liver tests. Researchers Watkins and Kaplowitz thought they would find the
culprit in hydrocodone’s interaction with acetaminophen.
”Our jaws dropped when we got the data,” Watkins said. ”It doesn’t have
anything to do with the opiate. It’s good ol’, garden-variety
Acetaminophen is more popular than aspirin or ibuprofen. Each week, one in
five U.S. adults uses it for pain or fever, a 2002 survey found.
Acetaminophen is included in numerous over-the-counter and prescription
medications, making overdose possible as people unwittingly combine drugs.
Overdoses of acetaminophen are the leading cause of acute liver failure.
”A week doesn’t go by when I don’t have to talk to someone about how much
they’re taking,” said Kathleen Besinque of the USC School of Pharmacy.
Watkins said people considering switching painkillers should know that
others have their own side effects, such as internal bleeding and stomach
New research under way at the University of North Carolina may determine if
acetaminophen’s effect on the liver continues for long-term, high-dose
users, or if the body adapts, Watkins said.
On the Net: JAMA: http://jama.ama-assn.org <http://jama.ama-assn.org/>
Copyright 2006 The Associated Press <http://www.ap.org/>
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