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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-.
LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].
Show detailsOVERVIEW
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 In 2004, Hydroxycut products containing ephedra were withdrawn from use in the United States because of cardiovascular risks and in 2009 because of hepatotoxicity.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).
Product Name | Condition | Major Listed Ingredients |
---|---|---|
Hydroxycut Hard Core Elite [Muscle Tech] | Weight loss, fat burning, enhanced energy and mental focus | Caffeine [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 focus | Conjugated 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 Weight | Weight loss | Calcium (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 Gummies | Weight loss | Thiamine (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 Free | Weight loss | Calcium [150 mg], Robusta coffee extract, papaya, maqui, blackberry, amla extract, saffron extract |
Pro Clinical Hydroxycut Instant Drink Mix | Weight loss | Hydroxycut 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 Women | Weight loss | Folic acid (200 mcg), Biotin (300 mcg), Iron (2 mg) Caffeine [225 mg], Mango, Kiwi, Avocado oil, Robusta coffee extract, hydrolyzed collage, silicon dioxide |
Hydroxycut Platinum | Weight loss | Green 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 Black | Weight loss | Caffeine (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 loss | Folic 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 Starting | Time After Stopping | ALT (U/L) | Alk P (U/L) | Bilirubin (mg/dL) | Other |
---|---|---|---|---|---|
Started Hydroxycut (1.86 g green tea extract daily) | |||||
5 weeks | 0 | 3131 | 171 | 7.8 | Admission |
2 days | 3962 | Peak values | |||
9 weeks | 4 weeks | 304 | 1.3 | ||
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
Product labeling at DailyMed, National Library of Medicine, NIH
CHEMICAL FORMULAS AND STRUCTURES
DRUG | CAS REGISTRY NUMBER | MOLECULAR FORMULA | STRUCTURE |
---|---|---|---|
EGCG | 989-51-5 | C22-H18-O11 | |
Ephedra sinica | OM54525000 | Unspecified | Unspecified |
ANNOTATED BIBLIOGRAPHY
References updated: 12 April 2018
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- Navarro VJ, Lucena MI. Hepatotoxicity induced by herbal and dietary supplements. Semin Liver Dis 2014; 34: 172-93. [PubMed: 24879982](Review of HDS induced liver injury including regulatory problems, difficulties in diagnosis and assessing causality; mentions Hydroxycut and Herbalife as multi-ingredient supplements implicated in rare instances of severe, acute liver injury).
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- Seeff LB, Bonkovsky HL, Navarro VJ, Wang G. Herbal products and the liver: a review of adverse effects and mechanisms. Gastroenterology 2015; 148: 517-532. [PubMed: 25500423](Extensive review of possible beneficial as well as harmful effects of herbal products on the liver mentions that multi-ingredient supplements have been implicated in many cases of liver injury including proprietary agents marketed under the names Herbalife, Hydroxycut and OxyELITE Pro).
- Stickel F, Shouval D. Hepatotoxicity of herbal and dietary supplements: an update. Arch Toxicol 2015; 89: 851-65. [PubMed: 25680499](Extensive review of liver injury due to HDS mentions that Hydroxycut products have been associated with both hepatocellular and cholestatic injury).
- Araujo JL, Worman HJ. Acute liver injury associated with a newer formulation of the herbal weight loss supplement Hydroxycut. BMJ Case Rep 2015; 2015. [PMC free article: PMC4434303] [PubMed: 25948859](41 year old man developed jaundice 8 weeks after starting Hydroxycut “SX-7 Clean Sensory formulation” [bilirubin 8.3 mg/dL, ALT 6,218 U/L, Alk P 109 U/L, INR 5.0], with transient hepatic encephalopathy but subsequent complete resolution within 3 months of stopping).
- Haimowitz S, Hsieh J, Shcherba M, Averbukh Y. Liver failure after Hydroxycut™ use in a patient with undiagnosed hereditary coproporphyria. J Gen Intern Med 2015; 30: 856-9. [PMC free article: PMC4441672] [PubMed: 25666208](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).
- Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al.; United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology 2015; 148: 1340-52. [PMC free article: PMC4446235] [PubMed: 25754159](Among 899 cases of drug induced liver injury enrolled in a prospective database between 2004 and 2012, HDS were implicated in 145 [16%] of which 5 were attributed to Hydroxycut [Navarro. Hepatology 2014]).
- Zheng EX, Navarro VJ. Liver injury from herbal, dietary, and weight loss supplements: a review. J Clin Transl Hepatol 2015; 3: 93-8. [PMC free article: PMC4548352] [PubMed: 26357638](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).
- García-Cortés M, Robles-Díaz M, Ortega-Alonso A, Medina-Caliz I, Andrade RJ. Hepatotoxicity by Dietary Supplements: A tabular listing and clinical characteristics. Int J Mol Sci 2016; 17(4). pii: E537. [PMC free article: PMC4848993] [PubMed: 27070596](Listing of published cases of liver injury from HDS products including 11 reports describing a total of 57 cases attributed to Herbalife products published between 2004 and 2015).
- Avigan MI, Mozersky RP, Seeff LB. Scientific and regulatory perspectives in herbal and dietary supplement associated hepatotoxicity in the United States. Int J Mol Sci 2016; 17: 331. PubMed Citation (Overview of the US regulations regarding herbal and dietary supplements and role of FDA, Department of Agriculture, Federal Trade Commission and Office of Dietary Supplements of the NIH in assessment of safety of HDS products including actions taken against Hydroxycut, Lipokinetix and OxyELITE Pro when reports of liver injury appeared in postmarketing phase).
- Marcus DM. Dietary supplements: What's in a name? What's in the bottle? Drug Test Anal 2016; 8 (3-4): 410-2. PubMed Citation (Commentary on regulation of HDS products concludes: "the marketing of botanical supplements is based on unfounded claims that they are safe and effective", and "there is no reason to take herbal medicines whose composition and benefits are unknown and whose risks are evident").
- Brown AC. An overview of herb and dietary supplement efficacy, safety and government regulations in the United States with suggested improvements. Part 1 of 5 series. Food Chem Toxicol 2017; 107 (Pt A): 449-71. [PubMed: 27818322](Summary of the US regulations on safety and efficacy of herbal and dietary supplements).
- Brown AC. Liver toxicity related to herbs and dietary supplements: Online table of case reports. Part 2 of 5 series. Food Chem Toxicol 2017; 107 (Pt A): 472-501. [PubMed: 27402097](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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- Hepatocellular Jaundice due to Hydroxycut in Monozygotic Twins.[J Clin Exp Hepatol. 2024]Hepatocellular Jaundice due to Hydroxycut in Monozygotic Twins.Sigurdarson SS, Kristjansson M, Bjornsson ES. J Clin Exp Hepatol. 2024 Mar-Apr; 14(2):101294. Epub 2023 Oct 13.
- Hydroxycut-induced Liver Toxicity.[Ann Med Health Sci Res. 2014]Hydroxycut-induced Liver Toxicity.Kaswala D, Shah S, Patel N, Raisoni S, Swaminathan S. Ann Med Health Sci Res. 2014 Jan; 4(1):143-5.
- Acute Compartment Syndrome in the Setting of Weight Loss Supplements and Exercise-Induced Rhabdomyolysis.[Eur J Case Rep Intern Med. 2022]Acute Compartment Syndrome in the Setting of Weight Loss Supplements and Exercise-Induced Rhabdomyolysis.Rath P, Fichadiya H, Elkattawy S, Jesani S, Messalti M, Fichadiya H, Sherer C. Eur J Case Rep Intern Med. 2022; 9(3):003113. Epub 2022 Mar 16.
- Review OxyELITE Pro.[LiverTox: Clinical and Researc...]Review OxyELITE Pro.. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. 2012
- Review Hydroxycut hepatotoxicity: a case series and review of liver toxicity from herbal weight loss supplements.[World J Gastroenterol. 2008]Review Hydroxycut hepatotoxicity: a case series and review of liver toxicity from herbal weight loss supplements.Dara L, Hewett J, Lim JK. World J Gastroenterol. 2008 Dec 7; 14(45):6999-7004.
- Hydroxycut - LiverToxHydroxycut - LiverTox
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