Tag: mpl

December 31, 2001 'Awa (Kava Kava)

Analysis of Kava Side Effects Reports Concerning the Liver–Causal relationship with concomitant medication probable

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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December 31, 2001 'Awa (Kava Kava)

Analysis of Kava Side Effects Reports Concerning the Liver–Doubtful Causality

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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December 31, 2001 'Awa (Kava Kava)

Analysis of Kava Side Effects Reports Concerning the Liver–Causal relationship cannot be evaluated due to information status

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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December 31, 2001 'Awa (Kava Kava)

Analysis of Kava Side Effects Reports Concerning the Liver–Causal relationship probable at monograph-conforming dosage

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)

From the original 32 suspected cases, there are only 4 cases with probable causality to kava that remain after substraction of the double entries, the cases unrelated to kava as well as the improbable or doubtful ones. Of these 4 cases, only one is related to a monograph-conforming dosage regimen (Strahl et al. 1998). The remaining 3 cases should be therefore classified as usages associated with overdosages. In the only kava side effect case associated with recommended use and a somewhat causal certainty, there seems to be an existing relationship to an immunoligical condition in combination with a congentical cytochrom P450-2D6 deficency. A comparable cause could also possibly be related to one case associated with overdosage (IKS-Nr. 2000-0014; see below).

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December 31, 2001 'Awa (Kava Kava)

Analysis of Kava Side Effects Reports Concerning the Liver–Probable cause relationship related to overdosage of kava extract

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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December 31, 2001 'Awa (Kava Kava)

Analysis of Kava Side Effects Reports Concerning the Liver–Literature

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)

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