Date:   7/23/2006 11:02:54 AM ( 18 y ago)
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http://www.tylenol.com/page.jhtml?id=tylenol/news/subprrg.inc

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Study Shows Tylenol Damages Liver


By Staff

(AXcess News) Washington - A recent study at the University of North Carolina Chapel Hill has found that people who take high doses of Acetaminophen, the main ingredient found in Extra Strength Tylenol, may be at risk of liver damage.

The makers of Tylenol, McNeil, PPC, Inc., a subsidiary of Johnson & Johnson, In. (NYSE: JNJ) have not commented on the study's findings. The only information on Tylenol and liver risks is found on McNeil's website. JNJ has not commented publicly, though McNeil's information still lists old findings that may be misleading. The FDA has not said whether an investigation will be conducted into proper labeling.

The study, paid for by Purdue Pharma and published Wednesday in the Journal of the American Medical Association, found that the highest recommended dose of the drug caused an increase in liver enzymes in healthy adults, a sign of damage.

Researchers were surprised by the findings since previous studies had shown that Tylenol in combination with hydrocodone caused liver damage. Therefore, experts had thought the liver toxicity was associated with hydrocodone.

This new study clearly shows that the Tylenol poses the risk, rather than the hydrocodone.

Tylenol is the leading brand of acetaminophen, which is found in more than 200 types of pain relievers and cold remedies. An estimated 100 million Americans take acetaminophen safely each year. It is an alternative to aspirin for people who are concerned about its gastrointestinal side-effects.

The study was based on a trial, during which 145 healthy volunteers at two U.S. medical centers received either a placebo, Extra Strength Tylenol or prescription painkillers that contained acetaminophen, such as Percocet, an opioid drug containing oxycodone.

Patients took the medication or placebo every six hours for 14 days.

Aminotransferase, a liver enzyme that when found at elevated levels can indicate possible liver damage, was measured daily for eight days and at regular intervals after that.

Out of 106 patients, 41, or 39 percent, taking acetaminophen alone or with another drug experienced an increase in liver enzymes to more than three times the upper limit of normal amount.

Twenty-seven patients, or 25 percent, had enzyme levels exceeding five times normal, and eight patients, or 8 percent, had eight times the normal amount of enzyme.

Three times the normal level of aminotransferase is considered the threshold at which doctors become concerned about possible liver damage.

Enzyme levels continued to increase in patients for up to four days after they stopped taking acetaminophen. It took as long as 11 days for their enzymes to return to normal levels, researchers said.

Dr. Paul B. Watkins of the University of North Carolina Chapel Hill, lead author of the study, attributed the sharply elevated enzymes to the Tylenol and not to the opioid medications.

The scientists said that patients who really need Tylenol should not stop taking it. If they are concerned they should discuss their medication with their doctor before considering switching.

http://www.axcessnews.com/modules/wfsection/article.php?articleid=10349
 

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