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.

Complete Article Here?

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.

Click Here for Complete Article

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).

Read Complete Article Here

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.

Click Here to Read Complete Article

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)

[1] Anonym. Konsequenzen f?r Kava-Pr?parate in der Schweiz. Pharm Ztg 2000; 145(42):3494.

[2] Arzneimittelkommission der Deutschen Apotheker. Kava-Kava und Kavain-haltige Arzneimittel. Pharm Ztg 2001; 146(46):4017.

[3] Arzneimittelkommission der Deutschen Apotheker. Kava-Pr?parate und Kavain-haltige Arzneimittel. Dtsch Apoth Ztg 2001; 141(46):5412.

[4] Barrio J, Castiella A, Cosme A, Lopez P, Fernandez J, Arenas JI. [Hepatotoxicity caused by cloxacillin]. Rev Esp Enferm Dig 1997; 89(7):559-560.

[5] Barrio J, Castiella A, Lobo C, Indart A, Lopez P, Garcia-Bengoechea M et al. [Cholestatic acute hepatitis induced by amoxycillin-clavulanic acid combination. Role of ursodeoxycholic acid in drug-induced cholestasis]. Rev Esp Enferm Dig 1998; 90(7):523-526.

[6] Bauer TM, Bircher AJ. Drug-induced hepatocellular liver injury due to benzylpenicillin with evidence of lymphocyte sensitization. J Hepatol 1997; 26(2):429-432.

[7] Beeley L, Gourevitch A, Kendall MJ. Jaundice after oral penicillin. Lancet 1976; 2(7998):1297.

[8] Benichou C. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol 1990; 11(2):272-276.

[9] Bint AJ. Esters of penicillins–are they hepatotoxic? J Antimicrob Chemother 1980; 6(6):697-699.

[10] Bralet MP, Zafrani ES. [Hepatitis caused by the amoxicillin-clavulanic acid combination. An example of drug-induced biliary hepatotoxicity]. Ann Pathol 1996; 16(6):425-429.

[11] Brauer R-B, Pfab R, Becker K, Berger H, Stangl M. Fulminantes Leberversagen nach Einnahme des pflazlichen Heilmittels Kava-Kava. Z Gastroenterol 2001; 39:491.

[12] Bustamante BM, Perez AF, Rayon MM, Garcia HA, Berenguer LJ. [Cholestatic hepatitis caused by amoxycillin-clavulanic acid. Report of a new case]. Gastroenterol Hepatol 1997; 20(4):187-189.

[13] Caballero Plasencia AM, Valenzuela BM, Martin Ruiz JL, Guilarte Lopez-Manas J. [Hepatotoxicity caused by amoxicillin, clavulanic acid or both?]. Gastroenterol Hepatol 1997; 20(1):45-46.

[14] Escher M, Desmeules J. Hepatitis associated with Kava, a herbal remedy for anxiety. Br Med J 2001; 322(20.01.01):139.

[15] Farrell GC. Drug-induced hepatic injury. J Gastroenterol Hepatol 1997; 12(9-10):S242-S250.

[16] Galindo C, Buenestado J, Rene JM, Pinol MC. [Acute pancreatitis associated with hepatotoxicity induced by amoxicillin-clavulanic acid]. Rev Esp Enferm Dig 1995; 87(8):597-600.

[17] George DK, Crawford DH. Antibacterial-induced hepatotoxicity. Incidence, prevention and management. Drug Saf 1996; 15(1):79-85.

[18] Goland S, Malnick SD, Gratz R, Feldberg E, Geltner D, Sthoeger ZM. Severe cholestatic hepatitis following cloxacillin treatment. Postgrad Med J 1998; 74(867):59-60.

[19] Goldstein LI, Ishak KG. Hepatic injury associated with penicillin therapy. Arch Pathol 1974; 98(2):114-117.

[20] Hautekeete ML. Hepatotoxicity of antibiotics. Acta Gastroenterol Belg 1995; 58(3-4):290-296.

[21] Hewitt J, Hammond L. Adverse hepatic events associated with drug therapy. Med J Aust 1996; 165(6):347, 350.

[22] Kraft M, Spahn TW, Menzel J, Senninger N, Dietl K-H, Herbst H et al. Fulminantes Leberversagen nach Einahme des pflanzlichen Antidepressivums Kava-Kava. Dtsch med Wschr 2001; 126(36):970-972.

[23] Kurowski V. [Cholestatic jaundice induced by amoxicillin and clavulanic acid]. Dtsch Med Wochenschr 1996; 121(12):390-391.

[24] Larrey D, Palazzo L, Benhamou JP. Terfenadine and hepatitis. Ann Intern Med 1985; 103(4):634.

[25] Mizoguchi Y, Iwasaki M, Tsutsui H, Kobayashi K, Monna T, Morisawa S. Preparation of a drug-induced allergic hepatic disorder model with penicillin as hapten. Osaka City Med J 1991; 37(2):133-140.

[26] Olans RN, Weiner LB. Reversible oxacillin hepatotoxicity. J Pediatr 1976; 89(5):835-838.

[27] Onate J, Montejo M, Aguirrebengoa K, Ruiz-Irastorza G, Gonzalez dZ, Aguirre C. Hepatotoxicity associated with penicillin V therapy. Clin Infect Dis 1995; 20(2):474-475.

[28] Paine TF, Jr. Updating the side effects of the penicillins. Zhonghua Min Guo Wei Sheng Wu Xue Za Zhi 1978; 11(3):104-109.

[29] Perman E. [A severe adverse effect of penicillin on the liver. Drug insurance covered the compensation]. Lakartidningen 1998; 95(34):3536.

[30] Russmann S, Escher M, Stoller R, Lauterburg BH. Hepatotoxicity of Kava Kava (Piper methysticum) containing herbal drugs. Recent cases in Switzerland and investigations regarding the mechanism. J Exp Klin Pharmakol Toxicol 2001; 363(4):S40.

[31] Russmann S, Lauterburg BH, Helbling A. Kava hepatotoxicity. Ann Int Med 2001; 135(1):68-69.

[32] Sahai A, Villeneuve JP. Terfenadine-induced cholestatic hepatitis. Lancet 1996; 348(9026):552-553.

[33] Sa? M, Schnabel S, Kr?ger J, Liebe S, Schareck WD. Akutes Leberversagen durch Kava-Kava – eine seltene Indikation zur Lebertransplantation. Z Gastroenterol 2001; 39:491.

[34] Silvain C, Fort E, Levillain P, Labat-Labourdette J, Beauchant M. Granulomatous hepatitis due to combination of amoxicillin and clavulanic acid. Dig Dis Sci 1992; 37(1):150-152.

[35] Stoller R. Lebersch?digungen unter Kava-Extrakten. Schweiz ?rzteztg 2000; 81(24):1335-1336.

[36] Strahl S, Ehret V, Dahm HH, Maier KP. Nekrotisierende Hepatitis nach Einnahme pflanzlicher Heilmittel. Dtsch med Wschr 1998; 123:1410-1414.

[37] Weber E. Taschenbuch der unerw?nschten Arzneimittelwirkungen. 2 ed. Stuttgart, New York: Gustav Fischer Verlag, 1988.

[38] Westphal JF, Vetter D, Brogard JM. Hepatic side-effects of antibiotics. J Antimicrob Chemother 1994; 33(3):387-401.

[39] Yusoff IF, Nairn P, Morgan CA. Multiple organ failure related to pantoprazole. Aust N Z J Med 1999; 29(6):833-834.

Read Complete Article Here

Beesource Beekeeping » Providing Subsidies for Beekeepers

Joe Traynor

In appealing for government assistance, the bee industry (and bee researchers) emphasize the “billions of dollars” in value that honey bees are worth to agriculture – that without subsidies, bee colony numbers will continue to decline, causing severe economic consequences for the production of many agricultural crops.

Certainly the bee industry is undergoing major problems, most notably from parasitic mites, but the “billions of dollars benefit to agriculture” argument should be abandoned. Here’s why:

Over the past 20 years, CA’s almond acreage has increased to the point where one million bee colonies are now required for February pollination (at the rate of two colonies per acre). Because almonds bloom in February and because bees are released from almond orchards by mid-March, the one million colonies coming out of almond orchards represent a pool of bees that can be transported to any area of the U.S. for crop pollination purposes – provided the growers of such crops are willing to pay for transportation and related costs.

Almond growers pay dearly for their bees – rental fees are up to $50/colony and rising as new acreage goes in. Almond pollinatlon has completely changed the face of the U.S. beekeeping industry – without almond pollination income, many US. beekeepers would be out of business. Indeed, some beekeepers are increasing their colony numbers solely to supply bees for CA’s increasing almond acreage.

In essence, CA’s almond industry is subsidizing the U.S. bee industry to the tune of millions of dollars a year. Any government subsidy would be dwarfed by the infusion of money that the bee industry has already received and continues to receive from the almond industry.

Calculating costs of using farm machinery: a standardized procedure for Hawaii.

Title: Calculationg costs of using farm machinery: a standardized procedure for Hawaii.
Personal Authors: Huang, W. Y., Marutani, H. K., Vieth, G. R., Keeler, J. T.
Author Affiliation: College of Tropical Agriculture and Human Resources, University of Hawaii, Honolulu, Hawaii, USA.
Editors: No editors
Document Title: Departmental Paper – Hawaii Agricultural Experiment Station (USA) 1979
Abstract:

Based on the recommended method of the American Society of Agricultural Engineering, a modified procedure for calculating the costs of using farm machinery in Hawaii is developed. This modified procedure can handle the situations of highly variable annual machine utilization rates of Hawaii’s diversified agriculture. An example illustrating the computation procedure and case study of a typical watermelon farm are presented. The procedure is also used to analyse the relation between costs and annual utilization. The analysis indicates that a farmer who has a low annual machine utilization rate incurs a high cost for using the machine, due mainly to the high interest charge. Authors’ summary. KEYWORDS: TROPAG | Economics | development and social sciences | agricultural equipment | costs | production function | Hawaii.

Calculationg costs of using farm machinery: a standardized procedure for Hawaii. | Huang, W. Y., Marutani, H. K., Vieth, G. R., Keeler, J. T. | Departmental Paper – Hawaii Agricultural Experiment Station (USA) 1979 |