Kava Controversy Continues

Kava Controversy Continues

FRANKFURT, Germany--The controversy that began last November with the issuance by the German government of case studies possibly linking kava intake with hepatotoxicity shows no sign of abating. In the most recent development, a committee that advises the German Health Ministry about prescription drugs recommended that kava become a prescription-only product in Germany. Reuters Health reported that Ulrich Hagemann, deputy head of the Federal Institute of Drugs and Medical Devices (BfArM), expects the Health Ministry to accept the recommendation and that kava will become a prescription-only drug in Germany beginning July 1.

In late November, BfArM proposed revoking existing marketing authorizations for kava products and asked for public comment. Many manufacturers, including the German Medicines Manufacturers' Association (BAH), filed comments opposing a sales ban. According to Reuters, the BAH comments included a recommendation that kava become a prescription-only drug rather than having it banned outright. BfArM has not made a final ruling about a ban on kava sales.

Prescription status in Germany is different than that in the United States, as many practitioners understand and prescribe botanical medicines. In addition, making kava prescription status could allow the products to carry additional health information on contraindications and afford consumers the chance to consult with their doctors on use of the product. "The kinds of precautions we're looking at relate to prescription drugs and health conditions that consumers would be consulting about with a health professional," said Wayne Silverman, chief administrative officer with the American Botanical Council (ABC). "This is certainly better news than a ban."

Other countries have had mixed responses to the kava reports. In early January, the French Agency for the Safety of Health Products (AFSSAPS) announced it had suspended the sale of products and preparations containing kava. However, homeopathic treatments may still be sold in dilutions equal to or higher than 5CH. According to the agency, this decision was based on various factors, including the recent health concerns linked to kava from German and Swiss authorities. AFSSAPS recommended that those taking kava should stop. For a copy of the decision (in French), visitwww.agmed.sante.gouv.fr.

In Canada, Health Canada issued a health advisory in mid-January advising consumers not to use kava, in light of the reports of liver toxicity. The agency noted that it took the action as a result of the international health reports, and is reviewing the safety and effectiveness of kava. It also asked that health care professionals report any cases of liver toxicity in association with the use of kava products. Information on the advisory is available atwww.hc-sc.gc.ca/english/protection/warnings/2002/2002_02e.htm. After Health Canada issued its advisory, at least one supplement company (Boehringer Ingelheim) voluntarily stopped sales of kava in Canada.

In the United States, there has been no further official action by the Food and Drug Administration (FDA) since it issued a notice asking health practitioners to report any case reports involving possible liver damage from kava. Industry associations have been working with FDA to review the current Adverse Events Reports (AERs) and have indicated that many appear to be from patients with pre-existing medical conditions, concurrent use with pharmaceuticals or improper use of products.

In the meantime, the associations have advised companies and retailers to advise consumers of the possible health concerns, while noting that kava has been used for centuries in the South Pacific and has been reasonably expected to be safe. "The recently reported cases ... will need to be thoroughly evaluated before new conclusions can be drawn as to any relationship between responsible use of kava and liver disorders," concluded a statement from the American Herbal Products Association(AHPA).