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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].

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Hydroxycut

Last Update: April 12, 2018.

OVERVIEW

Introduction

Hydroxycut is the commercial name a variety of multi-ingredient nutritional supplements (MINS) marketed for weight loss, body building and “fat burning”. In 2004, Hydroxycut products containing ephedra were withdrawn from use in the United States because of cardiovascular risks and in 2009 because of hepatotoxicity. Nevertheless, Hydroxycut products with different ingredients are still commercially available and have continued to be implicated in cases of clinically apparent acute liver injury.

Background

Hydroxycut is the proprietary name of a series of multi-ingredient nutritional supplements that are typically marketed as weight loss, body building, “fat burning” and performance enhancement aids. Initial ingredients in the products included caffeine and ephedra which in animal studies led to weight loss. In 2004, the FDA banned the use of ephedra in nutritional supplements and the composition of Hydroxycut was altered, with removal of ephedra. The products were often labelled as “ephedra-free”. Ingredients varied in different forms of the Hydroxycut products, but they generally included caffeine, green tea extract and proprietary mixtures of botanicals of undeclared concentration, source and purity. Hydroxycut products continued to be implicated in rare cases of acute liver injury. In 2009, after a review and identification of 23 cases of liver injury linked to Hydroxycut exposure, including one death, the FDA recalled all Hydroxycut products and mandated removal of products already in distribution. However, nutritional supplements under the name Hydroxycut continued to be marketed, but with different formulations. While reported cases of liver injury due to Hydroxycut decreased, they continued to appear. At present, several products labelled as Hydroxycut are available and still widely used. The table below lists several of the products with their full names and ingredients as listed on the product labels (reviewed: 02.24.2016).

Selected Hydroxycut Products (April 2018)

Product NameConditionMajor Listed Ingredients
Hydroxycut Hard Core Elite [Muscle Tech]Weight loss, fat burning, enhanced energy and mental focusCaffeine [270 mg], L-threanine [100 mg], Yohimbe extract [56.3 mg], Coleus forskohlii extract [100 mg], Green coffee extract [Coffea canephora robusta seed: 200 mg], Cocoa extract [100 mg: supplying theobromine], Yohimbe extract [56.3 mg]
Hydroxycut Hardcore CLA Elite [Muscle Tech]Weight loss, fat burning, enhanced energy and mental focusConjugated linoleic acid [CLA: 1000 mg], L-carnitine [250 mg], Garcinia indica extract [250 mg], Robusta coffee bean extract [200 mg], Raspberry ketone [125 mg}
Pro Clinical Hydroxycut Lose WeightWeight lossCalcium (145 mg), Robusta coffee bean extract (C. canephora robusta), Papaya, Blackberry, Saffron extract, Caffeine (200 mg), Maqui (Aristotella chilensis), Amia extract (Phyllanthus)
Pro Clinical Hydroxycut GummiesWeight lossThiamine (1.5 mg), Riboflavin (1.7 mg), Vitamis B6 (1 mg) and B12 (1.2 mcg), Folic acid (400 mcg), Pantothenic acid (10 mg), Robusta coffee extract (200 mg).
Pro Clinical Hydroxycut Caffeine FreeWeight lossCalcium [150 mg], Robusta coffee extract, papaya, maqui, blackberry, amla extract, saffron extract
Pro Clinical Hydroxycut Instant Drink MixWeight lossHydroxycut Blend [340 mg] with Robusta coffee extract, papaya, blackbery and saffron extract; and HydroxyBoost with caffeine [135 mg], Maqui and Amla extract
Hydroxycut Max for WomenWeight lossFolic acid (200 mcg), Biotin (300 mcg), Iron (2 mg) Caffeine [225 mg], Mango, Kiwi, Avocado oil, Robusta coffee extract, hydrolyzed collage, silicon dioxide
Hydroxycut PlatinumWeight lossGreen coffee bean extract [200 mg], Red mango extract, white kidney bean extract, Ashwagandha extract, Bacillus coagulans, Caffeine [200 mg], Choline, L-theanine, Huperzine-A, Cherry stem, Lemon and Tangerine concentrates, Vitamins A, B6, B12, C, D, E and K, Folic acid, Riboflavin, Niacin, Biotin, Iron, Iodine, Pantothenic acid, Zinc, Selenium Copper and Chromium
Hydroxycut BlackWeight lossCaffeine (200 mg), Robusta coffee bean extract (C. canephora robusta: 200 mg), Alpha lipoic acid (150 mg), Yohimbe extract, Black caraway extract, Purslane extract, Arugula extract, Chicory extract
Hydroxycut Max!Weight lossFolic acid (200 mcg), Biotin (300 mg), Iron (2 mg), Caffeine (225 mg), Mango, Kiwi, Avocado oil, Robusta coffee extract, hydrolyzed collagen

Hepatotoxicity

Hydroxycut has been associated with at least 50 instances of clinically apparent acute liver injury, but the specific Hydroxycut product implicated in different cases has varied and the specific ingredients responsible for liver injury remain unclear. In reported cases, the onset of injury was generally within 2 to 12 weeks of starting regular use. The typical presenting symptoms were fatigue, nausea, and abdominal pain followed by dark urine and jaundice. The pattern of liver injury was hepatocellular with serum aminotransferase levels as high as several thousand U/L, while alkaline phosphatase levels tended to be normal or minimally elevated (less than 3 times ULN). Liver biopsies showed an acute hepatitis-like picture, and severe cases were associated with confluent, submassive or massive necrosis. Immunoallergic and features were not common although autoantibodies were detected in a proportion of cases. The mortality rate overall was approximately 10% among cases with jaundice. In nonfatal cases, symptoms resolved within 1 to 8 weeks and laboratory tests return to normal within two to three months. The phenotype associated with Hydroxycut products was clearly an acute, self-limited viral hepatitis-like syndrome. Nevertheless, rare instances of cholestatic or mixed hepatitis with prolonged jaundice have also been reported in patients taking Hydroxycut products.

Likelihood score: B (likely cause of clinically apparent liver injury).

Mechanism of Injury

The cause of acute liver injury associated with Hydroxycut products was attributed to ephedra in the past and more recently to green tea extract (Camellia sinensis). Indeed, the clinical features of cases resemble those associated with the liver injury associated with green tea extracts. Green tea is rich in catechins, antioxidants that are oxidized by the fermentation processes that yield black tea. The most active catechin is epigallocatechin 3-gallate (EGCG), which is believed to be responsible for the antioxidant activity of green tea extract. In high doses, catechins and specifically EGCG causes acute hepatocellular injury in mice and rats, but the equivalent dose in humans (30-90 mcg/kg) is considerably higher than is usually administered in typical weight loss products (3-12 mg/kg). However, environmental and host factors may alter susceptibility to catechin injury, such as nutritional status, obesity, fasting and antioxidant status including hepatic glutathionine levels. This explanation of liver injury, however, does not explain recent cases of liver injury attributed to Hydroxycut cases, as the product now does not generally contain green tea extract (at least according to the product labels).

Outcome and Management

The acute hepatic injury associated with Hydroxycut exposure is usually self-limiting and resolves within 1 to 3 months. There is no evidence that corticosteroids are beneficial. Fatal cases of liver injury have been reported with Hydroxycut use. There is little information or cross reactivity to other weight loss products, but avoidance of green tea extract containing supplements is prudent. It is important to report cases of liver injury associated with HDS use and it is helpful to retrieve the actual product being used to verify the name, manufacturer and lot number as well as for possible future toxicologic analysis.

Drug Class: Herbal and Dietary Supplements, Nutritional Supplements, Multi-Ingredient

CASE REPORT

Case 1. 27 year old man with hepatitis attributed to Hydroxycut.

[Modified from Case 1: Stevens T, Qadri A, Zein NN. Two patients with acute liver injury associated with use of the herbal weight-loss supplement Hydroxycut. Ann Intern Med 2005; 142: 477-8. PubMed Citation]

A 27 year old man developed fatigue and jaundice 4 to 5 weeks after starting Hydroxycut (9 tablets per day) for weight loss. He denied previous liver disease, alcohol abuse, recent travel or risk factors for viral hepatitis. He denied taking any other medications or herbal preparations. Laboratory tests showed serum bilirubin of 7.8 mg/dL and marked elevations in serum aminotransferase levels (ALT 3131 U/L, AST 1808 U/L), with minimal increases in alkaline phosphatase (171 U/L) (Table). Liver tests worsened for a day and then rapidly improved.

Key Points

Medication:Hydroxycut (1.8 grams C. sinensis extract per day)
Pattern:Hepatocellular (R=54)
Severity:3+ (jaundice, hospitalization)
Latency:4-5 weeks
Recovery:1-2 months
Other medications:None

Laboratory Values

Time After StartingTime After StoppingALT (U/L)Alk P (U/L)Bilirubin (mg/dL)Other
Started Hydroxycut (1.86 g green tea extract daily)
5 weeks031311717.8Admission
2 days3962Peak values
9 weeks4 weeks3041.3
Normal Values <40 <150 <1.2

Comment

Green tea hepatotoxicity typically presents with jaundice and an acute viral hepatitis-like syndrome, and a markedly hepatocellular pattern of serum enzyme elevations and rapid improvement upon stopping. Hydroxycut contains high concentrations of green tea extract, although formulations frequently change. Because Hydroxycut, like many dietary supplements, is a brand of many products with many ingredients, it is difficult to implicate a specific ingredient of the product as the cause for liver injury. Other listed components of Hydroxycut products currently include calcium, chromium, potassium Garcinia cambogia, Gymnema sylvestre leaf extract, glucomannan, alpha-lipoic acid, willow bark extract, L-carnitine, caffeine, guarana extract, gelatin, silica and cellulose. The product implicated in this report from 2005, however, may have had other components including ephedra and green tea.

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Hydroxycut®

DRUG CLASS

Herbal and Dietary Supplements

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULAS AND STRUCTURES

DRUGCAS REGISTRY NUMBERMOLECULAR FORMULASTRUCTURE
EGCG 989-51-5 C22-H18-O11
ECGC chemical structure
Ephedra sinicaOM54525000UnspecifiedUnspecified

ANNOTATED BIBLIOGRAPHY

References updated: 12 April 2018

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    (23 year old man developed rash [“photosensitive”], fever and jaundice several months after starting Hydroxycut for weight loss [bilirubin 24.4 mg/dL, ALT 92 U/L, Alk P 91 U/L, INR 1.5] and had a prolonged and complicated course during which the diagnosis of hereditary coproporphyria was made, possibly explaining at least some of the clinical features).
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    (Review of literature on liver injury due to HDS products used for weight loss, focusing upon the case series of liver injury attributed to Herbalife, Hydroxycut and OxyELITE Pro products which was predominantly hepatocellular (acute hepatitis-like) and had a significant mortality rate).
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    (Description of an online compendium of cases of liver toxicity attributed to HDS products, lists at least 46 published cases of green tea associated liver injury and concludes that green tea may warrant a warning label).
  • Wong LL, Lacar L, Roytman M, Orloff SL. Urgent liver transplantation for dietary supplements: an under-recognized problem. Transplant Proc 2017; 49: 322-5. [PubMed: 28219592]
    (Among 2048 adult liver transplants recipients enrolled in the Scientific Registry of Transplant Recipients [SRTR] between 2003 and 2015, 625 were done for acute hepatic necrosis due to drug induced liver injury, half being due to acetaminophen and the 4th most frequent cause [n=21] being HDS products).
  • de Boer YS, Sherker AH. Herbal and dietary supplement-induced liver injury. Clin Liver Dis 2017; 21: 135-49. [PMC free article: PMC5117680] [PubMed: 27842768]
    (Review of the frequency, clinical features, patterns of injury and outcomes of HDS hepatotoxicity with specific mention of anabolic steroids, black cohosh, germander, green tea, kava, pyrrolizidine alkaloids and proprietary multiingredient nutrition supplements [MINS] such as Hydroxycut products).
  • Vega M, Verma M, Beswick D, Bey S, Hossack J, Merriman N, Shah A, et al; Drug Induced Liver Injury Network (DILIN). The incidence of drug- and herbal and dietary supplement-induced liver injury: preliminary findings from gastroenterologist-based surveillance in the population of the State of Delaware. Drug Saf 2017; 40: 783-7. [PMC free article: PMC5699929] [PubMed: 28555362]
    (A prospective, population based registry of cases of drug induced liver injury occurring in Delaware during 2014, identified 20 cases [2.7 per 100,000] overall, including 6 due to HDS products, all of which were proprietary multiingredient supplements, but none were Hydroxycut products).
  • Navarro VJ, Khan I, Björnsson E, Seeff LB, Serrano J, Hoofnagle JH. Liver injury from herbal and dietary supplements. Hepatology 2017; 65: 363-73. [PMC free article: PMC5502701] [PubMed: 27677775]
    (Review of the problems of liver injury and HDS products and challenges for future research concludes that stronger regulations are needed to address the increasing number of cases of HDS induced liver injury, particularly those linked to use of multiingredient dietary supplements such as Hydroxycut products).
  • Adike A, Smith ML, Chervenak A, Vargas HE. Hydroxycut-related vanishing bile duct syndrome. Clin Gastroenterol Hepatol 2017; 15: 142-4. [PubMed: 27151488]
    (49 year old woman developed jaundice 4 weeks after starting Hydroxycut for weight loss [bilirubin 6.9 mg/dL, ALT 115 U/L, Alk P 299 U/L], which improved after stopping but was followed by persistent Alk P elevations [237 to 253 U/L] without jaundice while liver biopsy showed bile duct loss).
  • Hu J, Webster D, Cao J, Shao A. The safety of green tea and green tea extracts consumption in adults - results of a systematic review. Regul Toxicol Pharmacol 2018 Mar 23. [Epub ahead of print] [PubMed: 29580974]
    (Extensive review of published toxicology of green tea concludes that hepatotoxicity may occur with high doses, the safe level in adults being 338 mg of EGCG daily when taken as pills or powder and 704 mg daily in tea preparations in beverage form).

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