Kava Pharmacuetical Laitan Banned in Switzerland for Health Reasons
Sep 2001
Surf Med News
Warning against Kava Kava
An antidepressant from a root-extract of kava kava lead to complete liver-failure in a female patient. This was not the first occurence. In Switzerland, one product has been taken off the market already.
Plant-derived remedies are becoming more an more popular, due to their nimbus of having few side-effects. A popular agent for depression and anxiety is, besides the well-known St. John´s Wort, an extract from the kava-plant, or kava kava. Physicians from the university clinic in Münster now report of a female patient, aged 60, who experienced "massive liver-failure after ingestion of the antidepressivum Kava Kava". To save her life she had to undergo liver-transplantation. This is not the first report of severe side-reactions from this extract.
Efficacy uncertain
The products are calles Antrages, Laitan or Kavasedon. They contain an extract from Piper methysticum, in Germany known as polynesian pepper or intoxicating pepper. For generations, natives of the Polynesian islands have taken the extract against anxiety. In Germany, 600,000 units (packets) were sold anually in the mid 90s, accounting for about 20 Million Marks (around 10,000,000 USD). Patients use tablets or prepare a tea from the roots, which are available as well. Even if lately there have been several hints for kava kava being efficacious in treating unspecific anxiety, in the view of many experts convincing evidence is still lacking.
...all that was left was kavaroot
The patient in Münster was hospitalized, after physician diagnosed apathy, lack of concentration, dark urine and increasingly yellow skin. "Typical signs of poor liver function" explains a physician. Shortly after, the liver completely failed. Her kidneys also had problems. There are several possible reasons why the detoxification-mechanism may collapse, and the physicains examined every one of them. Too much alcohol, hepatitis, medications: nothing. Only the antidepressant based on kavaroot extract.
Three to four tablets a day
The patient suffered from depression for eight years and took the herbal preparation daily, in the end three to four tablets per day. One to two is the recomended dose. "After we took everything under consideration, kava kava is the most likely reason for the liver failure." 16 less severe cases are officialy known in Switzerland and Germany. In Switzerland, a preparation named Laitan has been taken off the market; in Germany, it is still available.
Warnings from a year earlier
The Swiss interkantonal [inter-state] control agency issued a warning last year: "When symptoms like unusual fatigue, loss of appetite, nausea and (above all) jaundice occure, the consumption of kava-preparations has to be discontinued immediately. The medical Informationservice "Arzneitelegramm" pointed out, that only three out of 25 kava-products listed within the "Rote Liste" (the Red List, a collection of all approved pharmaceuticals and herbal remedies in germany with a basic description) issue a warning about possible liver-toxic properties. No entry gives a strong warning.
Instruction Leaflet to be changed
For the "Federal Institute for Pharmaceuticals and Medicinal Products" in Bonn, the 19 cases of liver-damage to date [Wow, three more in just two paragraphs! - ed] are reason enough to have the the instruction leaflets changed. Their offical, Hagemann said "The danger of liver-damage, even mild, needs to be listed as possible side-reaction. Patients with existing liver-damage should in no case ingest kava-preparations. But not all products will really have to issue this warning, as the amount of the agent differs a lot. "Products with only very little of this ingredient won´t have to change their information leaflet."
Caution with Kava Kava preparations
When customers will start finding the changed leaflets, he couldn´t say. Until then, he advices: "On the basis of the weak efficacy, everyone should review if he really needs kava at all." If one chooses to take it, he said, it is important to comply with the dosing instructions. Obviously this was not the case with the patient from Münster, who now is fine again. On answering why Laitan is not sheduled in Germany as well, the pharmacist and biochemist (Hagemann) says: "The Swiss regard the risk as too high regarding the potential. We don´t. There is not enough evidence right now to ban one of the kava-preparations."
Source: surf-med-news (never heard of them)
http://www.propflege24.de/Tips/2001_September/tip7.htm
An antidepressant from a root-extract of kava kava lead to complete liver-failure in a female patient. This was not the first occurence. In Switzerland, one product has been taken off the market already.
Plant-derived remedies are becoming more an more popular, due to their nimbus of having few side-effects. A popular agent for depression and anxiety is, besides the well-known St. John´s Wort, an extract from the kava-plant, or kava kava. Physicians from the university clinic in Münster now report of a female patient, aged 60, who experienced "massive liver-failure after ingestion of the antidepressivum Kava Kava". To save her life she had to undergo liver-transplantation. This is not the first report of severe side-reactions from this extract.
Efficacy uncertain
The products are calles Antrages, Laitan or Kavasedon. They contain an extract from Piper methysticum, in Germany known as polynesian pepper or intoxicating pepper. For generations, natives of the Polynesian islands have taken the extract against anxiety. In Germany, 600,000 units (packets) were sold anually in the mid 90s, accounting for about 20 Million Marks (around 10,000,000 USD). Patients use tablets or prepare a tea from the roots, which are available as well. Even if lately there have been several hints for kava kava being efficacious in treating unspecific anxiety, in the view of many experts convincing evidence is still lacking.
...all that was left was kavaroot
The patient in Münster was hospitalized, after physician diagnosed apathy, lack of concentration, dark urine and increasingly yellow skin. "Typical signs of poor liver function" explains a physician. Shortly after, the liver completely failed. Her kidneys also had problems. There are several possible reasons why the detoxification-mechanism may collapse, and the physicains examined every one of them. Too much alcohol, hepatitis, medications: nothing. Only the antidepressant based on kavaroot extract.
Three to four tablets a day
The patient suffered from depression for eight years and took the herbal preparation daily, in the end three to four tablets per day. One to two is the recomended dose. "After we took everything under consideration, kava kava is the most likely reason for the liver failure." 16 less severe cases are officialy known in Switzerland and Germany. In Switzerland, a preparation named Laitan has been taken off the market; in Germany, it is still available.
Warnings from a year earlier
The Swiss interkantonal [inter-state] control agency issued a warning last year: "When symptoms like unusual fatigue, loss of appetite, nausea and (above all) jaundice occure, the consumption of kava-preparations has to be discontinued immediately. The medical Informationservice "Arzneitelegramm" pointed out, that only three out of 25 kava-products listed within the "Rote Liste" (the Red List, a collection of all approved pharmaceuticals and herbal remedies in germany with a basic description) issue a warning about possible liver-toxic properties. No entry gives a strong warning.
Instruction Leaflet to be changed
For the "Federal Institute for Pharmaceuticals and Medicinal Products" in Bonn, the 19 cases of liver-damage to date [Wow, three more in just two paragraphs! - ed] are reason enough to have the the instruction leaflets changed. Their offical, Hagemann said "The danger of liver-damage, even mild, needs to be listed as possible side-reaction. Patients with existing liver-damage should in no case ingest kava-preparations. But not all products will really have to issue this warning, as the amount of the agent differs a lot. "Products with only very little of this ingredient won´t have to change their information leaflet."
Caution with Kava Kava preparations
When customers will start finding the changed leaflets, he couldn´t say. Until then, he advices: "On the basis of the weak efficacy, everyone should review if he really needs kava at all." If one chooses to take it, he said, it is important to comply with the dosing instructions. Obviously this was not the case with the patient from Münster, who now is fine again. On answering why Laitan is not sheduled in Germany as well, the pharmacist and biochemist (Hagemann) says: "The Swiss regard the risk as too high regarding the potential. We don´t. There is not enough evidence right now to ban one of the kava-preparations."
Source: surf-med-news (never heard of them)
http://www.propflege24.de/Tips/2001_September/tip7.htm