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. ####