Supplement Industry Review Concludes Kava Is Safe

NEWPORT BEACH, Calif.--Contrary to the recent advisories coming out of Europe and Canada, the U.S. herbal supplement industry has declared kava safe, stating it is not independently a risk factor for liver-related adverse events. As part of an industry coalition, the National Nutritional Foods Association (NNFA) released an analysis on kava safety detailing the adverse event reports (AERs) on kava.

In order to evaluate the scientific evidence, monitor regulatory developments and address public relations issues related to kava, NNFA joined an industry coalition of dietary supplement associations last November. The coalition also included the American Herbal Products Association, the Council for Responsible Nutrition and the Utah Natural Products Alliance. The coalition hired Donald Waller, Ph.D., who is a board-certified toxicologist and professor at the University of Illinois in Chicago, to review AERs regarding kava and liver toxicity. The analysis, titled "Report on Kava and Liver Damage," is a review of more than 50 AERs from the United States (26) and Germany (30).

While all of the German cases reported some liver-associated effect, only five of the U.S. cases identified liver-related problems in persons reportedly consuming kava. These five cases included a 52-year-old woman who was hospitalized for congestive heart failure and acute renal failure--a self-professed weekend binge drinker, she was taking no less than 20 supplements and several over-the-counter (OTC) medications. A second case was a 60-year-old woman who was undergoing radiation therapy and a multi-drug chemotherapy regimen--her liver enzymes returned to normal levels once she ceased chemotherapy and stopped taking herbs. The third U.S. case involved a 44-year-old woman who used kava chronically, and was also taking five drugs at unspecified doses or frequencies that were metabolized by the liver and may be associated with her liver damage. The fourth AER involved a 45-year-old woman who was admitted to the hospital for jaundice and eventually required a liver transplant--her therapy regimen was questionable, according to Waller, as her physician originally reported she was not taking any medications, but later revised his statement to say she was taking Aciphex, a gastric acid secretion inhibitor. She also reportedly took kava for eight weeks at half the recommended dose, but later said she chronically consumed a full dose of kava for four months. The final case involved a 51-year-old female with elevated liver function that was reportedly resolved after ceasing consumption of three herbal products, including kava--she was taking nine herbal products simultaneously for at least two months, but did not report dosages for any of these products.

In regard to the German AERs, Waller said they were "seriously lacking in details" and "did not provide adequate clinical information." In summary of the German reports, Waller said, "There are only a few of these cases in which kava might be directly associated with liver damage, although speculation about the cause of liver injury in even these few cases is not scientifically supportable in the absence of more complete information."

In his conclusion, Waller stated, "based on the data available to me at this time, there is no clear evidence that the liver damage reported in the U.S. and Europe was caused by the consumption of kava." However, Waller warned, "The medical community and the general public should be made aware that concomitant intake of prescription drugs associated with liver damage, excessive alcohol consumption and pre-existing liver disease or hepatitis with compromised liver function are conditions which may preclude any kava consumption." NNFA pointed out that this conclusion is consistent with the association's scientific backgrounder on kava, which can be accessed at the NNFA Web site (www.nnfa.org).

Regarding potential regulatory action in the United States, NNFA provided the Food and Drug Administration (FDA) with its analysis earlier this week and met with representatives from FDA on Feb. 22. NNFA stated it will continue to monitor the situation and report significant actions to members.

Share this article: Email, Slashdot, Digg, Del.icio.us, Yahoo!MyWeb, Windows Live Favorites, Furl
Add this article feed to: RSS, My Yahoo, Newsgator, Bloglines