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Liver Toxicity of Acetaminphen Ignored by FDA

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01/19/2002

FDA CHASES ALLEGED CASES OF LIVER TOXICITY FROM KAVA KAVA HERB WHILE 70,000

CASES OF LIVER TOXICITY FROM ACETAMINOPHEN ARE IGNORED

SAN DIMAS, CA- Based upon reports from Europe that the stress-relieving herbal

product kava kava (Peper methysticum) is possibly associated with liver

problems, the US Food & Drug Administration has announced it is seeking help

from the public and health professionals in determining if there are any cases

of liver toxicity emanating from the use of kava kava. Yet the FDA continues to

ignore the 70,000 confirmed cases of liver toxicity that occur annually from

acetaminophen pain relievers. The American Poison Control Centers count about

70-100 deaths per year from acetaminophen poisoning. More than 8 billion

acetaminophen pills are sold annually.

Health authorities in Switzerland and Germany have prohibited the sale of kava

kava based upon reports of adverse effects. About 25 cases of liver toxicity

have been reported throughout Europe. Merck permenently discontinued sale of its

two kava products in Germany in December. The two kava products generated over

$220 million of sales annually for Merck. But the herb was used in conjunction

with prescription pharmaceuticals so it is dfficult to conclude that kava is the

sole cause of the liver toxicity. The US FDA issued their letter in December

with a hotline number for consumers or health authorities to call the FDA's

MedWatch program.

FDA Ignores Antidote

Additionally, the FDA is also ignoring a plea by a doctor to add the antidote to

acetaminophen poisoning to over-the-counter tablets which would avoid liver

toxicity altogether. James P. Andrus of the Department of Pediatrics at Stanford

University Medical School has called upon the FDA and manufacturers of

acetaminophen to include N acetyl-cysteine (NAC) in pain relief pills to prevent

liver toxicity. [british Medical Journal, Vol. 323, Sept. 15, 2001] N acetyl

cysteine is commonly used to treat acetaminophen toxicity and is an

over-the-counter sulfur-bearing food supplement. [Postgraduate Medicine, Vol.

105, April 1999]

Acetaminophen overdose results in more calls to poison control centers in the

United States than overdose with any other pharmacologic substance. [Am J Health

System Pharm, Volume 56, June 1999] The American Liver Foundation reports that

35% of cases of severe liver failure are caused by acetaminophen poisoning which

may require organ transplantation. [uSA TODAY, August 13, 2001]

Toxicity occurs in the liver when levels of glutathione, an antioxidant that is

concentrated in the liver, are depleted by acetaminophen. Dr. Andrus says the

problem is best treated by prevention and suggests 200 milligrams of NAC be

added to a 500-milligram acetaminophen tablet.

Acetaminophen also increases the relative risk of kidney failure by 40 percent

when taking as little as two acetaminophen tablets per week. The risk of kidney

failure increases 200 percent among individuals who take 1000 or more

acetaminophen pills over a lifetime. [N Eng J Med, Volume 331, Dec. 22, 1994]

Tylenol (McNeil Labs, J & J) is the most widely known brand of acetaminophen. ####

 

Written By: Bill Sardi

 

 

 

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