Germany May Discontinue Kava's OTC Status

BERLIN--According to information that just came to light in the United States, the German Federal Institute of Drugs and Medical Devices (BfArM) has linked the herb kava kava to 24 cases of hepatotoxicity (liver toxicity) in the past few years. The agency sent a letter Nov. 8 to kava manufacturers and marketers asking their opinions as to whether kava should continue to be licensed as an over-the-counter (OTC) drug. (Editor's note: Approximately 200 supplements have been approved by the Commission E to be sold as non-prescription drugs in Germany; most of these "drugs" are sold as dietary supplements in America.) In most of the reported cases, prescription pharmaceuticals had also been used, although five people reported only using kava.

However, the allegation that kava leads to liver problems is news to the U.S. herbal industry. The American Botanical Council (ABC) and the American Herbal Products Association (AHPA) have partnered to investigate and evaluate the adverse event reports (AERs) that BfArM has on kava. Currently, both ABC (www.herbalgram.org) and AHPA (www.ahpa.org) report that there is no documented mechanism to link kava consumption with liver failure.

BfArM has been monitoring the hepatotoxic effects of kava for a year ever since increased incidences of AERs with kava began being reported in 1998. The agency now has the ability to withdraw the license to sell kava as a drug in Germany.

Commission E, which is a panel under BfArM, advises the agency when a non-prescription herb is up for re-registration. The Commission E monograph for kava (published in 1990) noted no known side effects for kava use, except temporary yellowing of the skin, hair and nails. According to Mark Blumenthal, president of ABC, the commission advised that kava products should be labeled with claims that they may be linked to potential liver problems and that the products should only be used for only four-week periods. However, BfArM did not use these recommendations for kava product labeling and is instead moving toward eliminating the drug license for kava products. Unless the manufacturers respond by Dec. 10, then BfArM will come out with a new policy.

"In Germany, these companies have already gone through a drug approval process," Blumenthal said, adding that these companies are behind many kava studies and have set up their own adverse event reporting systems. "Most of the German companies will probably come back and say `we don't think [kava] is as bad as the evidence might indicate.'" He also said that these companies might also suggest selling kava as prescription-only. Sales might drop off, but there would still be kava available for those who wanted it. "It still remains unclear what will happen. We probably won't know until next year."

"I think anyone selling kava should become familiar with all information about kava," Blumenthal advised. "If I were a manufacturer of kava, I would at least think about relabeling my product suggesting that people with a history of liver disease should not use the product unless under the supervision of a physician, at the very least."