Risk of Liver Injury Associated with Green Tea Extract in SLIMQUICK® Weight Loss Products: Results from the DILIN Prospective Study

Abstract

Introduction Herbal and dietary supplements (HDS) have been increasingly recognized as a cause for acute liver injury1, 2. HDS products frequently contain numerous ingredients, and are marketed under various product names. A perusal of marketed weight loss products indicates that green tea extract is a common ingredient in many. We aimed to describe the course and outcome of six patients who developed liver injury attributed to SLIMQUICK® weight loss products. Methods Patients with suspected drug induced liver injury were enrolled in a prospective study of the Drug-Induced Liver Injury Network (DILIN) and causality was assessed by a panel of hepatologists. During the period under study, 6 of 1091 cases of liver injury were attributed to a SLIMQUICK® product and were assigned causality scores of probable, highly likely, or definite. Results Six cases of acute liver injury attributed to SLIMQUICK® products were enrolled in the DILIN prospective study between 2007 and 2011. All were women aged 22 to 58 years. Two had a normal body weight and four were mildly obese (body mass index 22.9 to 32.2 kg/m2). All were taking SLIMQUICK® products for weight loss and no patient reported prior use. Laboratory tests revealed a hepatocellular pattern of injury, with initial alanine aminotransferase (ALT) levels above 1000 U/L in all but one patient. Three patients were hospitalized and one underwent successful liver transplantation. No patients died of liver injury. GTE and/or its component catechins were listed among the ingredients for 5 of the 6 products. Conclusions SLIMQUICK® products can lead to severe acute hepatocellular liver injury, which may result in transplantation. Given the frequency of GTE as a component in weight loss products, this ingredient should be studied further as a possible cause for liver injury.

Liver Injury Associated with Sporting Activities

“…76,77 In a recent report from DILIN, all six of the patients who were taking SlimQuick weight loss products that contain GTE were women with a median age of 44 years and the mean time from taking SlimQuick to DILI onset was 32 days (range: 12 to 66 days). 74 All of the patients had an acute hepatocellular injury at presentation with serum ALT levels above 1000 U/L in all but one and 4 were jaundiced. Three patients were hospitalized, and one underwent liver transplantation.…”

“…Without standardized chemical analysis and product manufacturing, it is not possible to determine the exact amount of GTE in each supplement, but liver injury is suspected to occur secondary to exposure at levels much higher than that of green tea consumption alone. 74 Indeed, a randomized, placebo-controlled trial showed that daily consumption of GTE with total catechins amounting to 1.3 g was associated with moderate to severe ALT elevations in 5.1% of treated women compared with 0.7% in the placebo arm. 75 However, none of the patients had symptoms or concomitant increases in alkaline phosphatase or bilirubin levels and all resolved with GTE discontinuation.…”

“…Three patients were hospitalized, and one underwent liver transplantation. 74 In the Spanish DILI Registry, three cases of liver injury attributed to C. sinensis extracts also presented with a severe acute hepatocellular injury pattern with jaundice. 78 The duration of GTE use and time to onset ranged from 17 to 121 days and 5 to 121 days, respectively.…”

Botanicals and Hepatotoxicity

“…The major catechins include epicatechin (EC), epigallocatechin (EGC), epicatechin‐3‐gallate (ECG), and epigallocatechin‐3‐gallate (EGCG) . Multiple cases of herbal‐induced liver injury have been attributed to GTE …”

“…In recent years the dietary supplement / wellness market has grown from $9.4 billion in 1994 to $36.7 billion in 2014 in the US . The Dietary Supplement Health and Education Act of 1994 (DSHEA) spurred the rapid growth of the DS market, which was paralleled by the increase in DS‐related health complications due to lack of consistent premarketing safety assessments …”