Joining other European nations such as France and Switzerland, the German health authorities yesterday announced an immediate ban on the sale of the herbal remedy kava kava, on the grounds that it can damage the liver.
The Federal Institute for Drugs and Medical Devices (BfArM) cited more than 40 cases of severe liver damage which have been linked to the use of kava kava (Piper methysticum), although experts elsewhere have dismissed many of these cases as unsubstantiated.
Kava kava is used by many people as a sedative, a muscle relaxant or a diuretic, but the BfArM said that it had evidence that the herb could also cause liver failure (three out of the 40 cases cited were fatal and a further six required a complete liver transplant). However, it also noted that in most of the cases, livers recovered after the individuals stopped taking the herb.
The authorities said that the sale of kava kava in small quantities as a homeopathic remedy will still be permitted, but that all other sales must stop immediately.
The German decision was not unexpected, as the BfArM had already issued a statement late last year introducing a preliminary ban on kava kava products excepty in very small amounts. That decision prompted a vociferous response from the BAH, the German Medicines Manufacturers' Association, a group which represents nearly 50 companies producing kava kava products, delaying the final introduction of the ban.
The manufacturers had hoped to persuade the authorities to make kava kava a prescription drug, reasoning that it was easier to control use of the product that way without removing it completely from the market. That course of action was also supported by a panel of experts advising the German authorities, but the BfArM has the last word in cases of this sort and has decided that the safest course of action is to ban the herb completely.
The German decision is bound to be received with dismay in the US, where calls have been growing from consumer groups for a similar ban. This has been staunchly opposed by the powerful manufacturing lobby, which has argued, with some foundation, that there is no concrete evidence linking the remedy to liver damage or any other adverse reaction, and that a blanket ban would deprive many thousands of people of a much needed remedy without due cause.
It is also indicative of the difference in approach adopted by the European and American authorities, with the Europeans tending to err on the side of caution and consumer protection, while the American approach tends to be based more on actual scientific evidence. A similar situation can be seen in the two blocs' approach to genetically modified food.
The US authorities are far from being maverick with the lives of patients, however, and are very quick to react if any product is clearly found to have an adverse effect. The FDA has already issued a warning about the possible dangers of using kava kava, but has shown no real sign of imposing a compulsory ban on the product.
The question is, if the link between kava kava and liver failure is finally proven, how many liver transplants or even deaths could have been prevented by a more cautious approach on the part of the US authorities, even with the warning already issued by the FDA. Surely, caution must be the watchword when the lives of consumers are potentially at risk, even if this means a substantial drop in sales for the supplement makers?