Category: ‘Awa (Kava Kava)

Translation to English by Lindenmaier M and Brinckmann J
31. December 2001
Analysis of hepatotoxic reactions listed by the BfArM (German Federal Institute for Drugs and Medical Devices)

1. Total Listed Cases
Referring to the non-official second listing of the BfArM as a foundation, there is a database of 32 side effect reports, including those reported by the Swiss health authorities (IKS), the WHO, as well as those cases described in the medical literature. The number of 32 reports is of course not synonymous to 32 cases of confirmed causality. The list contains duplicate reports and questionable classifications. When one collects all the available data for the individual cases, one arrives inevitably at another evaluation of the data.

2. Duplicate Entries
With a more accurate observation of the case reports listed by the BfArM, one finds a range of duplicate entries. Obviously, the duplicate entries were not reconciled against each other when the information was obtained from different sources. Therefore, the report of one and the same case can lead to a threefold entry, if, on the one hand, the event is reported directly from the patient, and on the other hand, the event is also reported via the manufacturer’s duty of notification, and finally, the treating phyisician also turns in a case report. These redundant data entries are not only difficult to recognize, but the inflated number of cases has led to a shift in the risk evaluation for a drug substance. In the case of the BfArM listings, mistakes in data transfer have exacerbated this situation.
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Causal relationship with concomitant medication probable

In the causality evaluation of suspected cases of undesired drug effects, influences from the co-medication may possibly be involved. In its press release, the BfArM intentionally emphasized that 18 of the 24 cases were attributed to kava, in spite of a known causal relationship with the co-medication. Upon closer inspection, this assessment by the BfArM appeared to be arbitrary: After subtracting the above mentioned cases and duplicate reports, 11 suspected cases remain. Due to the concomitant circumstances and the ingestion of other medications with known liver damaging potential, there is considerable doubt in respect to an objective portrayal of risk, in contrast to how this was portrayed in the press release.In principle, the participation of kava can not be absolutely ruled out, even if the co-medication provides solid evidence for other causes. Hence, the following registered cases are classified as “improbable”.

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Translation to English by Lindenmaier M and Brinckmann J
31. December 2001

Analysis of hepatotoxic reactions listed by the BfArM (German Federal Institute for Drugs and Medical Devices)

Three of the known suspected cases of kava-related hepatic side effects cannot be easily negated but a conclusive correlation is not possible. In the following cases, no co-medications, or only preparations without a known hepatotoxic potential, are listed. Based on the experiences from the previously listed cases, however, it should not be assumed that no suspicious co-medications were taken. The BfArM failed to list known co-medications in more than one case, but experiences with the handling of spontaneous side effect reports show that crucial information is often not obtainable due to poor cooperation by the patient. This dilemma of every drug safety protocol agent should, however, not automatically justify the classification of ?certain causality?, as it had been expressed by the BfArM in a press release.

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Translation to English by Lindenmaier M and Brinckmann J
31. December 2001

Analysis of hepatotoxic reactions listed by the BfArM (German Federal Institute for Drugs and Medical Devices)

In six of the reports, the background information is so scarce that a complete evaluation of the case is not possible. In several cases, it is not even clear what type of side effects actually occurred. Reports of this kind can only be used as an argument to improve the pharmacovigilance process; if such kind of ?rumors? persist, these incidences will doubtlessly receive more attention.

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Translation to English by Lindenmaier M and Brinckmann J
31. December 2001

Analysis of hepatotoxic reactions listed by the BfArM (German Federal Institute for Drugs and Medical Devices)

In addition to the above mentioned case related to recommended usage (Strahl et al.), there are three cases with a possible causality to kava, associated with non-recommended dosages. One such case can be classified as drug abuse (Kraft et al. 2001).In one case, a contributing immunological reaction and a concurrent cytochrom-P450-2D6 deficiency could be detected (IKS-case 2000-0014). The official justification for a causal relationship in another case (IKS-case 2000-3052) is based on erroneous correlations and should therefore be classified as doubtful.

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