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[SSRI-Research] Tylenol Linked to Liver Woes

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Thu, 06 Jul 2006 01:15:34 -0000

[sSRI-Research] Tylenol Linked to Liver Woes

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

 

Overreliance on toxic drugs is killing healthy people. And the FDA

has done next to nothing to prevent drug-induced harm.

 

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 results. " 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

212-595-8974

veracare

 

 

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 record.

 

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.''

 

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 irritation.

 

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/>

 

FAIR USE NOTICE: This may contain copyrighted (C ) material the use

of which has not always been specifically authorized by the copyright

owner. Such material is made available for educational purposes, to

advance understanding of human rights, democracy, scientific, moral,

ethical, and social justice issues, etc. It is believed that this

constitutes a 'fair use' of any such copyrighted material as provided

for in Title 17 U.S.C. section 107 of the US Copyright Law. This

material is distributed without profit.

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