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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
Ephedra is a genus of plants one species of which is known as Ma Huang (Ephedra sinica), which has been used in traditional Chinese medicine for centuries as a stimulant and antiasthmatic agent, and was recently introduced into use in the United States and Europe as a weight loss agent and aid in body building. Ma Huang and Ephedra species containing ephedrine alkaloids have been linked to multiple potentially severe side effects, including clinically apparent liver injury and has been banned from sale in the United States and elsewhere.
Background
Ephedra is prepared from the aerial parts of plants belonging to the genus Ephedra, family Ephedraceae. The 45 species of Ephedra are found worldwide, but Ephedra sinica is used predominantly and is native to China where it was first used therapeutically. Ephedra sinica is an herbaceous perennial with a strong pine odor and astringent taste which accounts for its Chinese name – Ma Huang – which can be translated as “yellow astringent” or “yellow hemp.” Ma Huang is purported to increase mental acuity and to improve sexual performance, increase circulation, and decrease weight through an increase in sympathetic nervous system activity and thermogenesis. It is also used for allergies, allergic rhinitis, colds, flu, fever, chills, nasal congestion, bronchospasm and asthma. The active ingredient of Ma Huang appears to be ephedrine and other related sympathomimetic alkaloids, which probably account for its therapeutic efficacy as well as its adverse effects. Not all Ephedra species contain ephedrine alkaloids, particularly those native to the United States. Ephedrine was a component of many herbal weight loss and body building products (such as those sold under the names Ma Huang and Hydroxycut). The typical dose was 1.5 to 9 grams of the decocted herb daily or as herbal tea prepared by boiling dried green stems in water. Side effects were not uncommon and included nervousness, anxiety, palpitations, tachycardia, gastrointestinal upset, nausea, diarrhea, headache, and dizziness. Ephedrine has also been implicated in an increased risk for myocardial infarction, stroke and sudden death and was banned from sale in the United States in April 2004.
Hepatotoxicity
Despite its apparent safe use for centuries in Chinese traditional medicine, Ma Huang was linked to many serious and potential fatal side effects since its widescale use in Western countries for weight loss. The major reported serious adverse events were cardiovascular, including hypertension, palpitations, myocardial infarction, seizures, transient ischemic attacks, cerebrovascular accidents and sudden death. Ephedra preparations have also been implicated in more than a dozen instances of clinically apparent, acute liver injury. The time to onset ranged from a few weeks to more than 6 months, but averaged 12 weeks, presenting with symptoms of fatigue, nausea and abdominal discomfort followed by jaundice. The serum enzyme elevations were typically hepatocellular and the clinical syndrome resembled acute viral hepatitis. Immunoallergic features (rash, fever and eosinophilia) were uncommon as were autoantibodies. Recovery occurred within 1 to 6 months of stopping the ephedra preparation, but instances with acute liver failure and death or need for emergency liver transplantation have been reported. As with most herbal products, it is difficult to say whether the liver injury is due to ephedra itself as opposed to a contaminant or another undisclosed hepatotoxin in the herbal supplement. While cases of ephedra-associated liver injury are now rare in the United States, they continue to be reported from Asia, largely as a result of use of traditional Asian and Chinese medicines.
Mechanism of Injury
Ephedra sinica extracts contain multiple compounds including the sympathomimetic alkaloids ephedrine, pseudoephedrine, methylephedrine and norephedrine. The cardiovascular side effects and complications of ephedra use have been attributed to these sympathomimetic constituents. The liver injury has been attributed to ephedrine as well, but other constituents may be responsible for this idiosyncratic liver injury.
Outcome and Management
The severity of liver injury due to ephedrine ranges from mild, asymptomatic elevations in serum enzymes to clinically apparent acute liver injury and to acute liver failure. Chronic use of Ma Huang has been linked to a chronic hepatitis-like syndrome, but recovery was prompt when ephedra was stopped. There have been no instances of vanishing bile duct syndrome attributed to ephedra. Recurrence of liver injury is typical when ephedra is restarted, and rechallenge should be avoided. There is no apparent cross sensitivity to liver injury between Ma Huang and other weight loss agents or herbal preparations, but ephedrine was previously found in many commercial herbal preparations.
Other Names: Belcho, Chinese ephedra, Desert herb, Ephedrine, Heral ecstasy, Joint fir, Mongolian ephedra, Pakistani ephedra, Popotillo, Sea grade, Teamster’s tea, Yellow astringent, Yellow horse.
Drug Class: Herbal and Dietary Supplements
CASE REPORT
Case 1. Acute hepatitis due to Ma Huang.
[Modified from: Nadir A, Agrawal S, King PD, Marshall JB. Acute hepatitis associated with the use of a Chinese herbal product, ma-huang. Am J Gastroenterol 1996; 91: 1436-8. PubMed Citation]
A 33 year old woman developed nausea and abdominal discomfort a few days after starting Ma Huang for weight loss. She continued taking the product for another 3 weeks when she noted jaundice and sought medical attention. She had no history of liver disease, alcohol abuse or risk factors for viral hepatitis and liver tests were known to be normal two years earlier. She was taking no other medications. Initially, she did not reveal that she was taking an herbal product. On examination, she was jaundiced and had hepatic tenderness but no fever, rash or signs of chronic liver disease. Laboratory tests showed raised serum bilirubin (4.5 mg/dL) and prominent elevations in serum aminotransferase levels (ALT 832 U/L, AST 376 U/L), with minimal increase in alkaline phosphatase (178 U/L). Tests for hepatitis A, B and C and a monospot were negative. Autoantibodies were present in moderate titers with ANA 1:160 and SMA 1:80. Ultrasound and computerized tomography of the liver were normal. She was initially thought to have viral hepatitis and sent home. She restarted Ma Huang but quickly felt worse, stopped and returned to the hospital where liver tests were found to be worse (Table). A liver biopsy showed changes of acute hepatitis with occasional eosinophils and plasma cells suggestive of drug induced liver disease. She stopped taking Ma Huang and when seen four months later, all liver tests were again normal.
Key Points
| Medication: | Ma Huang (Ephedra: unknown dose) |
|---|---|
| Pattern: | Hepatocellular (R=9.8) |
| Severity: | 3+ (jaundice, hospitalization) |
| Latency: | ~4 weeks |
| Recovery: | Within 16 Weeks |
| Other medications: | None |
Laboratory Values
Comment
A typical case of an acute hepatitis due to Ma Huang. The time to onset was difficult to assess, because she reported having nausea and abdominal discomfort “soon after” starting Ma Huang, but the time to jaundice was about 4 weeks. The clinical presentation was similar to acute viral hepatitis, which was the initial diagnosis, because the patient did not admit to using an herbal product (and this was the first published report of Ma Huang related acute liver injury). The finding of autoantibodies might suggest an autoimmune drug induced hepatitis. Immunoglobulin levels and serial ANA titers were not provided, but the liver histology did not suggest autoimmune hepatitis. Moderate levels of autoantibodies are not infrequent in cases of acute liver injury due to Ma Huang, but autoimmune features (hyperglobulinemia, prolonged course, response to corticosteroids) are not found.
PRODUCT INFORMATION
REPRESENTATIVE TRADE NAMES
Ephedra – Generic
DRUG CLASS
Herbal and Dietary Supplements
SUMMARY INFORMATION
Fact Sheet at National Center for Complementary and Integrative Health, NIH
CHEMICAL FORMULA AND STRUCTURE
| DRUG | CAS REGISTRY NUMBER | MOLECULAR FORMULA | STRUCTURE |
|---|---|---|---|
| Ephedra | ID: OM54525000 | Herbal mixture | Not applicable |
ANNOTATED BIBLIOGRAPHY
References updated: 10 February 2018
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- Seeff L, Stickel F, Navarro VJ. Hepatotoxicity of herbals and dietary supplements. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, pp. 631-58. (Review of hepatotoxicity of herbal and dietary supplements [HDS] mentions that.Ma Huang has been linked to numerous instances of acute, clinically apparent liver injury presenting with an acute hepatitis, often with fever, resolving rapidly on stopping).
- Ma huang: ephedra sinica. In, PDR for Herbal Medicines. 4th ed. Montvale, New Jersey: Thomson Healthcare Inc. 2007, pp 543-52.(Compilation of short monographs on herbal medications and dietary supplements).
- Dulloo AG, Stock MJ. Ephedrine in the treatment of obesity. Int J Obesity 1993; 17(suppl 1): S1-2. [PubMed: 8384172](Ephedrine is a sympathomimetic alkaloid found in several species of ephedra, which acts as a thermogenic agent increasing the metabolic rate; the safety of this approach to obesity has not been fully established).
- Nadir A, Agrawal S, King PD, Marshall JB. Acute hepatitis associated with the use of a Chinese herbal product, ma-huang. Am J Gastroenterol 1996; 91: 1436-8. [PubMed: 8678010](33 year old woman developed nausea within days of starting Ma Huang for weight loss, followed at 3 weeks by jaundice [bilirubin 4.5 rising to 8 mg/dL, ALT 832 U/L, Alk P 178 U/L, ANA 1:160, asterixis], resolving within 4 weeks of stopping: Case 1).
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- Pittler MH, Ernest E. Systematic review: hepatotoxic events associated with herbal medicinal products. Aliment Pharmacol Ther 2003; 18: 451-71. [PubMed: 12950418](Systematic review of published cases of hepatotoxicity due to herbal medications, listing 52 case reports or case series, most common agents being celandine [3], chaparral [3], germander [8], Jin Bu Huan [3], kava [1], Ma Huang [3], pennyroyal [1], skullcap [2], Chinese herbs [9] and valerian [1]).
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- Abourashed EA, El-Alfy AT, Khan IA, Walker L. Ephedra in perspective – a current review. Phytother Res 2003; 17: 703-12. [PubMed: 12916063](Review of history, botany, chemistry, pharmacology, clinical efficacy and safety of ephedra; by the year 2000, the FDA had received 1000 injury reports, often attributed to misuse, abuse or mislabeling of the product; only one report of hepatitis).
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- Nelson R. FDA issues alert on Ephedra supplements in the U.S.A. Lancet 2004; 363: 135. [PubMed: 14733193](Report on FDA ruling that ephedrine alkaloids present an unreasonable risk of injury, after review of ~155 deaths blamed on ephedra).
- Neff GW, Reddy R, Durazo FA, Meyer D, Marrero R, Kaplowitz N. Severe hepatotoxicity associated with the use of weight loss diet supplements containing Ma Huang or usnic acid. J Hepatol 2004; 41: 162-4. [PubMed: 15582145](Review of 12 patients with hepatotoxicity due to herbal weight loss agents, 10 due to Ma Huang [ephedra] with onset within 6 months in all but one [bilirubin 9.9-45 mg/dL, ALT 664-10,265 U/L], 1 died and 2 underwent liver transplantation, remaining recovered within 4-8 weeks).
- Skoulidis F, Alexander GJM, Davies SE. Ma huang associated acute liver failure requiring liver transplantation. Eur J Gastroenterol Hepatol 2005; 17: 581-4. [PubMed: 15827451](57 year old woman developed nausea soon after starting Ma Huang and jaundice one week later [bilirubin 24.9 mg/dL, ALT 1061 U/L, Alk P 196 U/L], with progressive liver failure and transplantation, the explant showing massive collapse).
- Clark BM, Schofield RS. Dilated cardiomyopathy and acute liver injury associated with combined use of ephedra, gamma-hydroxybutyrate, and anabolic steroids. Pharmacotherapy 2005; 25: 756-61. [PubMed: 15899737](40 year old man developed congestive heart failure and jaundice several months after starting anabolic steroids, ephedra and γ-hydroxybutyrate [bilirubin 3.9 mg/dL, ALT 2173 U/L, Alk P normal, INR 1.9], with slow recovery over next 18 months).
- Elinav E, Pinsker G, Safadi R, Pappo O, Bromberg M, Anis E, Keinan-Boker L, et al. Association between consumption of Herbalife nutritional supplements and acute hepatotoxicity. J Hepatol 2007; 47: 514-20. [PubMed: 17692424](12 cases of liver injury attributed to Herbalife products in Israel, 11 women, 1 man, ages 32 to 78 years, onset after 2 to 35 months [mean peak bilirubin 9.1 mg/dL, ALT 1481 U/L, Alk P 282 U/L, 1 with ANA], on stopping, 11 recovered and one died of hepatitis B reactivation; 3 had a positive rechallenge).
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- Stickel F. Slimming at all costs: Herbalife-induced liver injury. J Hepatol 2007; 47: 444-6. [PubMed: 17692988](Editorial in reference to Schoepfer [2007] and Elinay [2007] discussing the difficulties in assigning causality and identifying the toxic component in herbal mixtures, many patients take multiple products and each includes multiple components).
- Duque JM, Ferreiro J, Salgueiro E, Manso G. [Hepatotoxicity associated with the consumption of herbal slimming products]. Med Clin(Barc) 2007; 128: 238-9. Spanish. [PubMed: 17335732](3 cases of hepatotoxicity attributed to Herbalife products, women ages 49-54 years, with onset of liver injury after 1, 6 and 36 months [bilirubin 0.7, 0.8, and 26.6 mg/dL, ALT 138, 505 and 1890 U/L, Alk P 112, 166 and 425 U/L], resolving in all 3 upon stopping).
- Chao S, Anders M, Turbay M, Olaiz E, Mc Cormack L, Mastai R. [Toxic hepatitis by consumption Herbalife products: a case report]. Acta Gastroenterol Latinoam 2008; 38: 274-7. Spanish. [PubMed: 19157382](63 year old woman developed jaundice and pruritus 2.5 months after starting Herbalife products [peak bilirubin 17.5 mg/dL, ALT 847 U/L, Alk P 3 times ULN], resolving within 5 months of stopping).
- Manso G, López-Rivas L, Duque JM, Salgueiro E. Spanish reports of hepatotoxicity associated with Herbalife products. J Hepatol 2008; 49: 289-90; author reply 290-1. [PubMed: 18571274](Discussion of 4 cases of Herbalife hepatotoxicity from Spain [3 reported by Duque 2007], 2 occurring in sisters, suggesting a genetic propensity and an idiosyncratic drug reaction).
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- Chitturi S, Farrell GC. Hepatotoxic slimming aids and other herbal hepatotoxins. J Gastroenterol Hepatol 2008; 23: 366-73. [PubMed: 18318821](Review of hepatotoxicity of herbal medications focusing upon those used for weight loss including nitrosofenfluramine, usnic acid, ephedra, germander, skullcap and green tea).
- Dara L, Hewett J, Lim JK. Hydroxycut hepatotoxicity: a case series and review of liver toxicity from herbal weight loss supplements. World J Gastroenterol 2008; 14: 6999-7004. [PMC free article: PMC2773866] [PubMed: 19058338](Two women ages 33 and 40 years with onset of symptoms 1 and 4 weeks after starting Hydroxycut [bilirubin 0.7 and 20.9 mg/dL, ALT 1150 and 934 U/L, Alk P 299 and 112 U/L], resolving rapidly, ingredients including green tea but not ephedra; review of liver injury due to weight loss supplements including Ma Huang, Lipokinetix, Kava, green tea, Shou Wu Pian, germander and usnic acid).
- García-Cortés M, Borraz Y, Lucena MI, Peláez G, Salmerón J, Diago M, Martínez-Sierra MC, et al. [Liver injury induced by “natural remedies”: an analysis of cases submitted to the Spanish Liver Toxicity Registry]. Rev Esp Enferm Dig 2008; 100: 688-95. Spanish. [PubMed: 19159172](Among 521 cases of drug induced liver injury submitted to Spanish registry, 13 [2%] were due to herbals but none were attributed to ephedra or Ma Huang).
- Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang H, Rochon J; Drug Induced Liver Injury Network (DILIN). Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology 2008; 135: 1924-34. [PMC free article: PMC3654244] [PubMed: 18955056](Among 300 cases of drug induced liver disease in the US collected between 2004 and 2008, 9% of cases were attributed to herbal medications including at least one case attributed to a Hydroxycut weight loss product, but details not provided).
- Navarro VJ. Herbal and dietary supplement hepatotoxicity. Semin Liver Dis 2009; 29: 373-82. [PubMed: 19826971](Overview of the regulatory environment, clinical patterns, and future directions in research with HDS; specific discussion of Hydroxycut and traditional Chinese herbal medicines).
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- Jóhannsson M, Ormarsdóttir S, Olafsson S. [Hepatotoxicity associated with the use of Herbalife]. Laeknabladid 2010; 96: 167-72. Icelandic. [PubMed: 20197595](Five cases of Herbalife hepatotoxicity found in a survey in Iceland; 4 women, 1 man, ages 29 to 78 years, after 1 to 7 months of use, 4 with hepatocellular injury [bilirubin 1.5 to 18.2 mg/dL, ALT 456 to 2637 U/L, Alk P 149 to 712 U/L], all resolving upon stopping).
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- Molleston JP, Fontana RJ, Lopez MJ, Kleiner DE, Gu J, Chalasani N; Drug-induced Liver Injury Network. Characteristics of idiosyncratic drug-induced liver injury in children: results from the DILIN prospective study. J Pediatr Gastroenterol Nutr 2011; 53: 182-9. [PMC free article: PMC3634369] [PubMed: 21788760](Among 30 children with suspected drug induced liver injury, only one case was attributed to an herbal which was a Hydroxycut weight loss product).
- Stickel F, Kessebohm K, Weimann R, Seitz HK. Review of liver injury associated with dietary supplements. Liver Int 2011; 31: 595-605. [PubMed: 21457433](Review of current understanding of liver injury from herbals and dietary supplements focusing upon Herbalife and Hydroxycut products, green tea, usnic acid, noni juice, Chinese herbs, vitamin A and anabolic steroids).
- Teschke R, Wolff A, Frenzel C, Schulze J, Eickhoff A. Herbal hepatotoxicity: a tabular compilation of reported cases. Liver Int 2012; 32: 1543-56. [PubMed: 22928722](A systematic compilation of all publications on the hepatotoxicity of specific herbals identified 185 publications on 60 different herbs, herbal drugs and supplements including 3 publications on Ma Huang, 1 on ephedra species and 6 on Hydroxycut).
- Bunchorntavakul C, Reddy KR. Review article: herbal and dietary supplement hepatotoxicity. Aliment Pharmacol Ther 2013; 37: 3-17. [PubMed: 23121117](Systematic review of literature on HDS associated liver injury mentions that Ma Huang has been implicated in causes of liver injury including severe hepatitis and acute liver failure).
- Björnsson ES, Bergmann OM, Björnsson HK, Kvaran RB, Olafsson S. Incidence, presentation and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology 2013; 144: 1419-25. (In a population based study of drug induced liver injury from Iceland, 96 cases were identified over a 2 year period [2010-12], including 15 attributed to herbals or dietary supplements, but none to Ephedra, Ma Huang or a Hydroxycut product). [PubMed: 23419359]
- Hernández N, Bessone F, Sánchez A, di Pace M, Brahm J, Zapata R, A Chirino R, et al. Profile of idiosyncratic drug induced liver injury in Latin America. An analysis of published reports. Ann Hepatol 2014; 13: 231-9. [PubMed: 24552865](Systematic review of literature of drug induced liver injury in Latin American countries published from 1996 to 2012 identified 176 cases, none of which was attributed to Ma Huang or ephedra).
- 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.e7. [PMC free article: PMC4446235] [PubMed: 25754159](Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, 145 were attributed to herbal and dietary supplements, but none were attributed to a product specifically named Ma Huang or ephedra although many may have included ephredra or ephrine as one of the components).
- Woo HJ, Kim HY, Choi ES, Cho YH, Kim Y, Lee JH, Jang E. Drug-induced liver injury: A 2-year retrospective study of 1169 hospitalized patients in a single medical center. Phytomedicine 2015; 22: 1201-5. [PubMed: 26598920](Among 1169 adults admitted to a single Korean hospital over a 30 month period, 11 were diagnosed as having drug induced liver injury, 4 of whom had been exposed to ephedra containing herbs).
- Zhu Y, Li YG, Wang JB, Liu SH, Wang LF, Zhao YL, Bai YF, Wang ZX, Li JY, Xiao XH. Causes, Features, and Outcomes of Drug-Induced Liver Injury in 69 Children from China. Gut Liver 2015; 9: 525-33. [PMC free article: PMC4477997] [PubMed: 25717050](Among 1544 Chinese children admitted to a Beijing hospital for acute liver injury during a 3 year period, 69 were diagnosed as drug induced liver injury, 22% attributed to Chinese herbal medicines including 3 attributed to Ephedra sinica).
- The role of chemical fingerprinting: application to Ephedra.[Phytochemistry. 2003]The role of chemical fingerprinting: application to Ephedra.Schaneberg BT, Crockett S, Bedir E, Khan IA. Phytochemistry. 2003 Mar; 62(6):911-8.
- Cytotoxicity assessment of Ma-huang (Ephedra) under different conditions of preparation.[Toxicol Sci. 2000]Cytotoxicity assessment of Ma-huang (Ephedra) under different conditions of preparation.Lee MK, Cheng BW, Che CT, Hsieh DP. Toxicol Sci. 2000 Aug; 56(2):424-30.
- Benzaldehyde is a precursor of phenylpropylamino alkaloids as revealed by targeted metabolic profiling and comparative biochemical analyses in Ephedra spp.[Phytochemistry. 2012]Benzaldehyde is a precursor of phenylpropylamino alkaloids as revealed by targeted metabolic profiling and comparative biochemical analyses in Ephedra spp.Krizevski R, Bar E, Shalit OR, Levy A, Hagel JM, Kilpatrick K, Marsolais F, Facchini PJ, Ben-Shabat S, Sitrit Y, et al. Phytochemistry. 2012 Sep; 81:71-9. Epub 2012 Jun 21.
- Review Acute hepatitis associated with the use of a Chinese herbal product, ma-huang.[Am J Gastroenterol. 1996]Review Acute hepatitis associated with the use of a Chinese herbal product, ma-huang.Nadir A, Agrawal S, King PD, Marshall JB. Am J Gastroenterol. 1996 Jul; 91(7):1436-8.
- Review Ephedra in perspective--a current review.[Phytother Res. 2003]Review Ephedra in perspective--a current review.Abourashed EA, El-Alfy AT, Khan IA, Walker L. Phytother Res. 2003 Aug; 17(7):703-12.
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