Acute Hepatitis Induced by Greater Celandine (<i>Chelidonium majus</i>)

Stickel, Felix; Poschl, G.; Seitz, Helmut K.; R, Waldherr; Hahn, Eckhart G.; Schuppan, Detlef

doi:10.1080/00365520310000942

Cited by 84 publications

(42 citation statements)

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“…Historically, rechallenge tests have frequently been performed to establish drug-induced liver injury firmly, but this approach has now been abandoned due to high risks. Nevertheless, results are still rarely available from unintentional rechallenges reported for some DDS [2,33].…”

Section: Rechallenge Testmentioning

confidence: 99%

Causality assessment in hepatotoxicity by drugs and dietary supplements

Teschke

Schwarzenboeck

Hennermann

2008

Brit J Clinical Pharma

147

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Structured causality assessment of hepatotoxicity by drugs and dietary supplements (DDS) is a major clinical challenge, since temporal associations as the sole criteria for a valid evaluation are not acceptable. Initially, a clear intuition for an ad hoc evaluation is necessary, but only provisional, and must be followed by a diagnostic algorithm using a pretest, main test and post test. The evaluation is based on a variety of items such as latency period, course of alanine aminotransferase and alkaline phosphatase after DDS discontinuation, risk factors, co-medication, previous information on hepatotoxicity of the DDS, response to rechallenge, and exclusion of other diseases. It is essential that practising and hospital physicians as well as other key health professionals, such as pharmacists, gather all information required for a sound causality assessment, obviating major discussions by expert panels, manufacturers and health agencies in face of scanty and fragmentary data. Because pharmacogenetic alterations may trigger metabolic hepatotoxicity by a few DDS, levels in plasma and urine should be measured and may be helpful for diagnosis. Concomitant genotyping of cytochrome P450 and other enzymes may also be useful in future to minimize the risk of unwanted side-effects, including toxic liver disease elicited by DDS. Hepatotoxicity is a rare, unpredictable and inherent risk associated with the use of various drugs and dietary supplements (DDS) at recommended doses [1][2][3][4][5][6][7][8][9], and several excellent reviews have covered the broad spectrum of DDS hepatotoxicity [10][11][12][13][14][15][16][17][18][19][20][21][22][23]. Potentially hepatotoxic drugs include prescribed and over-the-counter medications, which are intensively studied before marketing both experimentally and in several thousands of healthy persons and patients regarding unwanted sideeffects, including hepatotoxicity [24,25]. Nevertheless, rare toxic liver injury cannot be excluded with certainty, as after marketing hepatotoxic reactions occur, for example, in 1:10 000 patients treated for specific diseases [11,18]. Moreover, there is little if any legal regulation of dietary supplements, which comprise a basket of herbs and teas as botanical supplements and weight loss supplements containing herbs and various substances [26][27][28][29][30][31][32]. In face of > 1100 potentially hepatotoxic drugs [17] and the emerging consumption of dietary supplements [13,26], DDS hepatotoxicity has a major impact not only on morbidity, including hospitalization, disability and liver transplantation, but also on mortality, liability and litigation.Early recognition and comprehensive documentation of DDS hepatotoxicity is mandatory at all stages of the disease, but current procedures for efficient, transparent and impartial causality assessment in suspected DDS hepatotoxicity are inadequate. At present, practising and hospital physicians, expert groups, manufacturers and healthcare agencies each use their own individual causality approach, open to dis...

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Section: Rechallenge Testmentioning

confidence: 99%

Causality assessment in hepatotoxicity by drugs and dietary supplements

Teschke

Schwarzenboeck

Hennermann

2008

Brit J Clinical Pharma

147

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“…Retrospective assessment of unintentional reexposure tests is cumbersome, because clinical conditions are variable, as shown in the present report (Tables 1 and 4) [1][2][3][4][5] and in previous case analyses [14,[36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51] . Specific criteria for reexposure tests are available since 1988 (Table 3) [31] and have been incorporated in the CIOMS scale (Table 4) [16,32,34] following successful use for validation purposes [33] .…”

Section: Discussionmentioning

confidence: 88%

“…In retrospect, a positive reexposure test has been confirmed in only 13/30 cases (43%) [16] , as ascertained by established criteria published previously [31] . Of note, none of these reports communicated criteria for the evaluation of the observed reexposure test [14,16,[36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51] . The use of inappropriate causality assessment methods in the analyzed case reports is difficult to reconcile [1][2][3][4][5] .…”

Section: Items For Hepatocellular Type Of Injurymentioning

confidence: 99%

“…Data problems of reexposure cases are not confined to Herbalife products (Table 4) but represent a general problem extending to liver injury by all herbal drugs, dietary supplements and herbal products [14,[36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51] . Analysis of 30 cases within the last three decades claiming a positive reexposure test revealed that in many cases detailed descriptions of the reexposure test and actual ALT values were lacking.…”

Section: Items For Hepatocellular Type Of Injurymentioning

confidence: 99%

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Herbalife hepatotoxicity: Evaluation of cases with positive reexposure tests

Teschke¹,

Frenzel²,

Schulze³

et al. 2013

WJH

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AIM:To analyze the validity of applied test criteria and causality assessment methods in assumed Herbalife hepatotoxicity with positive reexposure tests. METHODS:We searched the Medline database for suspected cases of Herbalife hepatotoxicity and retrieved 53 cases including eight cases with a positive unintentional reexposure and a high causality level for Herbalife. First, analysis of these eight cases focused on the data quality of the positive reexposure cases, requiring a baseline value of alanine aminotransferase (ALT) < 5 upper limit of normal (N) before reexposure, with N as the upper limit of normal, and a doubling of the ALT value at reexposure as compared to the ALT value at baseline prior to reexposure. Second, reported methods to assess causality in the eight cases were evaluated, and then the liver specific Council for International Organizations of Medical Sciences (CIOMS) scale validated for hepatotoxicity cases was used for quantitative causality reevaluation. This scale consists of various specific elements with scores provided through the respective case data, and the sum of the scores yields a causality grading for each individual case of initially suspected hepatotoxicity. RESULTS:Details of positive reexposure test conditions and their individual results were scattered in virtually all cases, since reexposures were unintentional and allowed only retrospective rather than prospective assessments. In 1/8 cases, criteria for a positive reexposure were fulfilled, whereas in the remaining cases the reexposure test was classified as negative (n = 1), or the data were considered as uninterpretable due to missing information to comply adequately with the criteria (n = 6). In virtually all assessed cases, liver unspecific causality assessment methods were applied rather than a liver specific method such as the CIOMS scale. Using this scale, causality gradings for Herbalife in these eight cases were probable (n = 1), unlikely (n = 4), and excluded (n = 3). Confounding variables included low data quality, alternative diagnoses, poor exclusion of important other causes, and comedication by drugs and herbs in 6/8 cases. More specifically, problems were evident in some cases regarding temporal association, daily doses, exact start and end dates of product use, actual data of laboratory parameters such as ALT, and exact dechallenge characteristics. Shortcomings included scattered exclusion of hepatitis A-C, cytomegalovirus and Epstein Barr virus infection with only globally presented or lacking parameters. Hepatitis E virus infection was considered in one single patient and found positive, infections by herpes simplex ORIGINAL ARTICLE

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“…The active "principia" are similar to those of opium, and have wellknown hepatotoxic effects [2][3][4] , although in animals an average daily oral dose of alkaloids up to 5 mg/kg has been proven to be safe [5] .…”

Section: Discussionmentioning

confidence: 99%

Drug-induced liver injury due to “natural products” used for weight loss: A case report

Tarantino

Pezzullo

Minno

et al. 2009

WJG

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Ta k i n g h e r b a l -e x t r a c t s t o l o s e w e i g h t i s a n underestimated health hazard. Often, these products contain active agents that can cause acute liver damage. In this case report, a 22-year-old female patient, who presented with a feature of cholestatic syndrome, was so sure that the "natural products" were not dangerous that she did not inform her physicians that she had taken them, making their task that much more challenging. Clinical presentation m i m i c k e d a c u t e c h o l e c y s t i t i s a n d t h e p a t i e n t underwent a cholecystectomy. Surgery was without any consequences and complications, although it did not completely cure the illness. She later admitted to having taken herbal remedies and this led to the correct diagnosis of phytotherapy-related hepatotoxicity and a successful therapeutic approach. The true incidence of phytotherapy-related hepatotoxicity and its pathogenic mechanisms are largely unknown. It is important to increase the awareness of both clinicians and patients about the potential dangers of herbal remedies.

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Acute Hepatitis Induced by Greater Celandine (Chelidonium majus)

Cited by 84 publications

References 1 publication

Causality assessment in hepatotoxicity by drugs and dietary supplements

Causality assessment in hepatotoxicity by drugs and dietary supplements

Herbalife hepatotoxicity: Evaluation of cases with positive reexposure tests

Drug-induced liver injury due to “natural products” used for weight loss: A case report

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