Shops defy 'danger warning' on herbal cure

Health food chain refuses to comply with medicines agency advice over remedy linked to liver failure

Sarah Boseley, health editor
Friday May 10, 2002
The Guardian

Kava Kava, a popular herbal remedy for anxiety recently linked to liver damage and death in reports from Germany, is still widely available in health food stores despite a voluntary agreement between the manufacturers and the medicines control agency to keep it off the shelves.

One chain of health food shops - Holland and Barratt - has defied the MCA, saying that it has taken too long to decide whether Kava Kava needs to be banned. Its action shows the toothlessness of the government body that licenses and regulates medicines but has only limited powers over herbal remedies, even though some have proved to have dangerous side effects alone or in combination with conventional drugs.

The MCA asked manufacturers not to supply Kava Kava and retailers not to stock it in December last year, because of serious side effects reported in Germany and Switzerland.

The committee on the safety of medicines, which advises the MCA, is still investigating 27 cases of reported liver damage in Germany and Switzerland and one in the UK. Six patients suffered liver failure, one of whom died and the other five required liver transplants.

All had taken Kava Kava, often in conjunction with other drugs or alcohol. The CSM is waiting to hear from the German authorities what part the herb from Polynesia played. While most retailers and manufacturers are abiding by the voluntary ban, a significant number of outlets still sell Kava Kava.

The Guardian has seen a concentrated form of the herb in an independent health food store, offering "30% kavalactones," thought to be the most likely cause of the side effects if Kava Kava is found to be implicated.

Stephen Nickless, a GP who practices in Kilburn, north London, said he was scandalised to see Kava Kava on sale in Holland and Barratt stores in Kilburn and in Richmond, Surrey. "I asked the shop assistant, and he said that it had been removed as a precautionary measure but was now back on the shelves because it was a false alarm," said Dr Nickless. "I phoned the MCA and was told the warning remained in force."

He said that, were problems to be found with electrical goods or children's toys, good retailers would withdraw items from sale and put warning notices in their shops. "There needs to be proper regulation of this sector with legal sanctions to enforce the rules and protect public safety."

Sharon Flynn, of Holland and Barratt, said that it was first contacted by the MCA last November. "We are now in May, and they haven't come up with information as to what the problem is," she said.

"A lot of people do have it back on sale. We've reviewed the information, and it does not suggest there is a major cause for concern. We were abiding by their voluntary withdrawal initially, but they still can't give us a reason why it should be off the shelves."

Vic Perfitt of the British Herbal Medicines Association, representing the manufacturers, said he regretted the attitude of those who were still stocking Kava Kava.

"The voluntary suspension of sale still exists as far as our company is concerned and the responsible end of the herbal manufacturers. Unfortunately some of them seem to be in my opinion slightly irresponsible because we don't yet know what has caused this problem."

The MCA said in a statement: "We do have concerns that the public may be confused if Kava Kava is on sale in some outlets but not others. There is no indication at present that the extent of evidence linking Kava Kava with liver toxicity would justify putting in an emergency prohibition.

"However, our view is that until we have confirmed expert independent advice from the CSM on what regulatory action or advice to the public may be required it would be prudent for the public not to take Kava Kava."