Continuous reporting of new cases in Spain supports the relationship between Herbalife® products and liver injury

Abstract

Our results support the relationship between the consumption of Herbalife products and hepatotoxicity, underscore the concern regarding the liver-related safety of this dietary supplement, and emphasize the need to establish further regulatory measures.

Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment

“…The TTK scale is widely used in Japan [74] , as recently reviewed [75] . In other countries, this scale is not or rarely [59] Kava 20 Teschke et al [60] Kava 36 Stickel et al [61] Kava 80 Schmidt et al [62] Greater Celandine 23 BfArM [63] Black cohosh 31 EMA [54] Herbalife products 12 Elinav et al [64] Herbalife products 12 Schoepfer et al [65] Kava 26 Teschke et al [12] Black cohosh 30 Mahady et al [42] Green tea 34 Sarma et al [43] Black cohosh 4 Teschke et al [47] Black cohosh 9 Teschke et al [48] Kava 31 Teschke [34] Hydroxycut 17 Fong et al [66] Black cohosh 22 Teschke et al [36] Greater Celandine 22 Teschke et al [37] Herbalife products 20 Manso et al [67] Various herbs 45 Chau et al [57] Greater Celandine 21 Teschke et al [32] Pelargonium sidoides 15 Teschke et al [38] Pelargonium sidoides 13 Teschke et al [39] Sum ( The data are derived from a study evaluating alternative causes in suspected HILI cases (n = 573) comprising the study cohort [5] . For the 275 CIOMS cases, causality assessment was performed with the updated CIOMS scale the original CIOMS scale, or both.…”

“…Among various causality assessment methods, the original and updated CIOMS scales were the preferred tools in cases of DILI [28] and HILI (Table 8) [5] , seen for 573 cases from 23 HILI reports evaluating alternative causes [12,32,34,[36][37][38][39]42,43,47,48,54,[57][58][59][60][61][62][63][64][65][66][67] . Transparency CIOMS based assessments should be reported or published as an original data set suitable for subsequent and independent assessments, rather than as final scores and corresponding causality levels, to improve data transparency.…”

Herbalife hepatotoxicity: Evaluation of cases with positive reexposure tests

“…Speculations about bacterial contamination with Bacillus subtilis in Herbalife products emerged [8,12] , and potentially hepatotoxic ingredients such as green tea extracts, ephedra sinica, aloe, or vitamin A overdose have been proposed as culprits [2][3][4]10] . In addition, overall case data quality was mixed due to confounding variables, missing firm exclusion of alternative explanations, and the use of problematic causality attribution methods [1][2][3][4][5][6][7][8][9][10] . For hepatotoxicity cases, even with stringent causality assessment the culprits remain undetected in up to 38% of severe liver disease [28] , and alternative causes are frequently found [16,29,30] , with up to 47% in initially assumed drug induced liver injury (DILI) cases [16,29] and with an average of 49% in initially suspected herb induced liver injury (HILI) cases [30] .…”

“…For hepatotoxicity cases, even with stringent causality assessment the culprits remain undetected in up to 38% of severe liver disease [28] , and alternative causes are frequently found [16,29,30] , with up to 47% in initially assumed drug induced liver injury (DILI) cases [16,29] and with an average of 49% in initially suspected herb induced liver injury (HILI) cases [30] . When adjusted for case duplications, Herbalife hepatotoxicity was suspected in 53 cases [1][2][3][4][5][6][7][8][9][10] . Among these were eight cases with high causality gradings for Herbalife products because of positive unintentional reexposure tests, though criteria to evaluate reexposure tests were not presented [1][2][3][4][5] .…”

“…Considerable interest focused on the question whether few Herbalife products are potentially hepatotoxic like some other herbal products and dietary supplements [1][2][3][4][5][6][7][8][9][10] . These reports created safety concerns and led to editorials [11][12][13] , commentaries [14][15][16] , and critical Letters to the Editor [17][18][19][20][21][22][23][24][25][26][27] , all addressing relevant issues [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] .…”