U.K. May Prohibit Unlicensed Kava Products

LONDON--The Medicines Control Agency (MCA), an executive agency in the United Kingdom's Department of Health established to regulate the quality, efficacy and safety of human medicines, reported that it is considering a proposal that would prohibit unlicensed kava-containing products. This follows a provisional opinion from the Committee on Safety of Medicines (CSM), which concluded that the possible therapeutic benefits of kava products do not outweigh the health risks.

MCA reported that it is currently aware of 68 cases worldwide in which liver problems have been associated with kava use. Among these cases, there were six liver transplants and three deaths allegedly linked to kava. In the U.K., three cases of liver toxicity have been reportedly linked to kava consumption.

Based on these findings, MCA will consult on a proposal to prohibit unlicensed kava products through Sept. 27, during which time MCA will also consider public comments. From these comments, MCA will decide whether to proceed with the proposal to ban unlicensed kava products. For those kava products with marketing authorizations--which make up a minority of kava products currently sold in the U.K.--CSM will create a final report to be discussed in the near future. The report will include CSM's findings, as well as comments from manufacturers of licensed kava products.

If the proposal passes for prohibiting unlicensed kava products, an order will be made under Section 62 of the Medicine Act of 1968 to prohibit the sale, supply and importation of these products.

Alasdair Breckenridge, chairman of CSM, reported, "Given the safety concerns surrounding the use of medicinal products containing the herbal ingredient kava, our advice is that it would be prudent for anyone taking such products to stop taking them."

In a letter he sent to health care professionals, Breckenridge stated that the level of risk associated with kava intake is not known, and rare health problems occur when kava is taken at normal doses. Health practitioners have been advised to question patients with liver problems about possible kava usage. "The mechanism of toxicity is not understood, and there are no clear predictors of toxicity," Breckenridge wrote.

When the association between kava and possible liver toxicity first surfaced in late 2001, MCA asked manufacturers and retailers to temporarily stop selling kava while it reviewed the safety data. According to MCA in its July 18 release, it and CSM welcome the continued support from the herbal sector for the voluntary withdrawal of kava pending the outcome of this consultation.

Steven Dentali, Ph.D., vice president of scientific and technical affairs at the American Herbal Products Association (AHPA) (www.ahpa.org), was of the opinion that countries should not be prohibiting kava products without solid evidence linking kava to liver problems. He stated that no link has been found between kava and liver failure, and the small number of people who have reported adverse events out of the millions who have taken kava every day should not have governments running scared. "There may be some people out there who do not do well with kava, but that doesn't mean that it isn't safe and effective for the rest of the population and should be pulled off the market," he said.

While the MCA press release is currently available at www.mca.gov.uk, the full consultation document will not be available until the week of July 22.

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