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A liver biopsy revealed acute hepatitis characterized by hepatocellular injury, with periportal fibrosis, cholestasis, ductal metaplasia and diffuse intralobular and periportal troxis necrosis consistent with a drug-induced etiology.

Acute liver injury induced by over the counter weight-loss herbal supplement Hydroxycut and Herbalife products have been reported previously[ 3 - 6 , 8 - 11 ]. These case reports were limited by the fact that liver biopsies were performed in only a few patients, confirming clinical suspicions histologically. In terms of our patients, all three had liver biopsy performed and all showed some common morphological features including diffuse lymphocytic infiltration of sinusoids and portal tracts, ductal metaplasia and toxic necrosis.

Some variations of morphological features could be explained by predominance of intrinsic or idiosyncratic mechanisms of hepatic injury, individual patient response to the affecting drug and duration of injury. No hyaline globules were identified in any of the three cases. The absence of histological findings and the fact that our patients had no history of chronic obstructive pulmonary disease excluded diagnosis of alphaantitripsin deficiency in all three cases.

Prussian blue and copper stains did not reveal excessive iron or copper depositions in the hepatocytes and Kupffer cells. Only one previous case of Hydroxycut-induced acute liver injury had reported findings on liver biopsy. Although the most likely explanation for the mechanism of liver injury caused by these herbal products is idiosyncratic reaction, one of the ingredients in Hydroxycut, green tea extract Camellia sinensis , has been linked with acute liver injury in other over the counter weight-loss herbal supplements[ 12 - 20 ].

In fact, the weight-loss herbal supplement Exolise Arkophama, Carros, France , which also contained C. Furthermore, several cases of hepatotoxicity were associated with another herbal weight-loss supplement, Cuur Scandinavian Clinical Nutrition, Sweden , which also contains the ethanolic dry extract of green tea C. Rechallenging patients with the same product led to hepatotoxicity, confirming the role of C. However, there have been cases of liver failure caused by green tea extract C.

The liver biopsy obtained in our patient who took Hydroxycut showed multi-lobular necrosis consistent with acute toxic necrosis and fulminant hepatitis. These findings are similar to the findings in patients with liver injury associated with green tea extract C. The exact mechanism of hepatotoxicity induced by Hydroxycut is unknown.

However, as this product contains green tea extract C. Prior investigation into the mechanism of hepatotoxicity by green tea extract was inconclusive[ 21 ]. Others have hypothesized that a possible allergic reaction to the green tea extract, contamination during the production of the extract or a metabolic idiosyncrasy are possible mechanisms of liver injury in these patients[ 16 ]. Both of our patients took several Herbalife weight-loss herbal products concurrently, similar to most of the previously reported cases of hepatotoxicity due to Herbalife products[ 8 - 11 ].

Therefore, it is difficult to identify the exact ingredient or mechanism that causes the liver injury, as in the previously documented cases[ 8 - 11 ].

In a previously reported case, one investigator was able to isolate contamination with Bacillus subtilis , in which the bacterial supernatant caused dose-dependent increase of LDH leakage in HepG2 cells[ 8 ]. Although not commonly known as a human pathogen, B. Investigators have also suggested that another explanation for hepatotoxicity due to Herbalife products could be secondary to locally restricted contamination with chemicals such as softeners, preservatives, flavor enhancers, pesticides, or heavy metals either intentionally added during the production process or contained in the unrefined raw herb extracts[ 24 ].

This contamination hypothesis could also explain the different patterns of pathology seen on liver biopsy specimens previously observed in patients with hepatotoxicity from Herbalife products as both predominantly cholestatic injury pattern and acute hepatitis pattern have been reported[ 8 - 11 ]. Our patients had findings consistent with acute hepatitis due to drug-induced liver injury on their liver biopsy specimens.

Due to the obesity epidemic, the usage of weight-loss herbal supplements has flourished. Green tea extract is one of the key components in many of the over-the-counter weight-loss herbal supplements. Although significant liver injury induced by herbal supplements taken for weight loss purposes is a rare event, we cannot ignore the fact that there have been multiple reported cases in the medical literature of hepatotoxicity associated with weight-loss herbal supplements including Hydroxycut and Herbalife products.

Even though our patients successfully recovered from the adverse reactions, we must bear in mind that the hospitalization and medical care of these patients were associated with significant cost and healthcare resource utilization, while there is no evidence that herbal supplements can help with weight-loss[ 26 ].

We must also consider the impact on patients with underlying chronic liver disease, in whom herbal weight loss medications could cause worsening in their synthetic function and even fulminant failure. In May of , the US Food and Drug Administration warned consumers to immediately stop using Hydroxycut products, citing linkage to liver damage in one patient who died due to liver failure[ 27 ].

However, Hydroxycut products are currently still available in many parts of the world. Likewise, Herbalife products are widely available globally. Furthermore, our cases once again demonstrated the importance of questioning patients regarding the usage of herbal or nutritional supplements at the time of evaluation. Sforza 28, Milano , Italy. Recent trends in use of herbal and other natural products. Two patients with acute liver injury associated with use of the herbal weight-loss supplement hydroxycut.

Acute liver injury associated with the herbal supplement hydroxycut in a soldier deployed to Iraq. Shim M, Saab S. Severe hepatotoxicity due to Hydroxycut: Severe hepatotoxicity following ingestion of Herbalife nutritional supplements contaminated with Bacillus subtilis.

Association between consumption of Herbalife nutritional supplements and acute hepatotoxicity. Herbal does not mean innocuous: Hepatotoxicity associated with the consumption of herbal slimming products. Med Clin Barc ; Hepatotoxicity associated with supplements containing Chinese green tea Camellia sinensis Ann Intern Med. Fulminant hepatitis during self-medication with hydroalcoholic extract of green tea. Eur J Gastroenterol Hepatol. Green tea extracts and acute liver failure: Bjornsson E, Olsson R.

Serious adverse liver reactions associated with herbal weight-loss supplements. Acute liver failure induced by green tea extracts: Acute hepatitis due to Exolise, a Camellia sinensis dried ethanolic extract [letter] Med Clin Barc ; Acute hepatitis associated with Camellia thea and Orthosiphon stamineus ingestion [letter] Gastroenterol Hepatol. Hepatotoxicity associated with green tea extracts [electronic letter].

Toxicity of green tea extracts and their constituents in rat hepatocytes in primary culture. Bacillus cereus and other Bacillus species. Bacillus subtilis as a cause of cholangitis in polycystic kidney and liver disease.

N Engl J Med. Slimming at all costs: Supplemental products used for weight loss. J Am Pharm Assoc ; Published online February This article has been cited by other articles in PMC.

Aloe has been widely used in phytomedicine. Phytomedicine describes aloe as a herb which has anti-inflammatory, anti-proliferative, anti-aging effects. In recent years several cases of aloe-induced hepatotoxicity were reported. But its pharmacokinetics and toxicity are poorly described in the literature.

Here we report three cases with aloe-induced toxic hepatitis. A yr-old woman, a yr-old woman and a yr-old woman were admitted to the hospital for acute hepatitis. They had taken aloe preparation for months. Their clinical manifestation, laboratory findings and histologic findings met diagnostic criteria RUCAM scale of toxic hepatitis. Upon discontinuation of the oral aloe preparations, liver enzymes returned to normal level. Aloe should be considered as a causative agent in hepatotoxicity.

The demand for dietary supplements has continually increased in recent years as the concept of 'well being' widely spread in Korea. The market value for dietary supplements in Korea was approximately billion won million USD in year 1 , and personal spending was approximately , won USD per year in 2. One of the leading products in Korea's dietary supplements market is aloe.

Aloe has been purported to have positive effects on wound healing, recovery from burn injury, cell growth, and immune modulation. However, cases of aloe-induced toxic hepatitis have been reported since We report 3 cases of aloe-induced toxic hepatitis in Korea. Case 1 A yr-old female patient with a 2 month history of dyspepsia was presented to our department. Past medical history and family history did not reveal any significant disease.

She also used drugs for arthralgia intermittently for several years. She did not take any alcohol. She had taken aloe tablets containing mg of an extract of Aloe arborescens and On admission, the patient's physical examination was normal.

Preparation of aloe which the patient had taken. A Container bottle and tablets. B Packs of aloe extract. Anti-HBs IgG was positive. Autoimmune markers were all negative. Abdominal ultrasonography showed reduced echogenicity of liver. Dilatation of intra- or extrahepatic bile ducts was absent. Liver biopsy revealed moderate portal infiltrates consisting of eosinophilis, neutrophils, and monocytes. There were inflammatory cell infiltration and acidophil body on the hepatic lobule.

There was no bile stasis Fig. Histopathological findings of the liver. Aloe tablets was immediately discontinued. ALT as well as total bilirubin gradually returned to normal level over several weeks Fig. Upon discontinuation of the oral aloe preparation, liver enzymes returned to normal level. Case 2 A yr-old female patient was presented to our department with a week history of fatigue. The patient did not take any alcohol or durgs.

She had taken aloe powder containing mg of an extract of Aloe vera Fig. Physical examination revealed jaundice on her sclera. She was the sales person of the aloe product she was taking. Abdominal ultrasonography was normal. Liver biopsy revealed severe portal and lobular infiltrates consisting of neutrophils and monocytes. There were several acidophilic bodies and ballooning cell change in hepatic lobule. There were bile-stasis and bile stained Kupffer cells Fig.

Aloe extract was immediately discontinued. We explained to her about the aloe-induced hepatotoxity and advised not to take it anymore. However, the patient started taking the same aloe extract again 1 month after her discharge from the hospital. Since a hepatitis recurred after re-challenge of aloe extract, we could confirm her diagnosis as aloe-induced toxic hepatitis.

The type of liver injury was determined as 'hepatocellular' since R ratio was After re-challenge arrow , liver enzymes go up again. Six months later, the patient was presented to our department with a 2 week history of jaundice. We recommended admission, but she refused to be admitted and she never visited our hospital again.

Case 3 A yr-old female patient was presented to our department with a 3 month history of epigastric discomfort. The patient did not take any alcohol or drugs. She had taken aloe extracts Fig.

On admission, the patient's physical examination was normal except mild tenderness on epigastric area. Autoimmune markers were negative. Abdominal ultrasonography showed increased echogenicity of liver. After 4 days, she visited our department for follow-up. The major driving force for the growth of the dietary supplements market is the perception that 'they are safe because they are natural'.

However, the recently reported cases of hepatotoxicity induced by natural substances 8 indicate that natural substances may not be entirely safe. There are about species of aloe. Among them, particularly aloe vera has been used in phytomedicine. There have been positive reports on aloe vera as anti-inflammatory, anticancer, analgesic, anti-aging as well as liver protective. But, clinical effectiveness of aloe vera was not sufficiently defined because there were no large and randomized studies 9.

In , Korea's National Institute of Safety Research conducted an experiment on the efficacy and toxicity of aloe There was no difference of natural killer cell activity between the aloe vera gel treated and control animals. To observe the toxicity of aloe gel, rats were given the high dose aloe orally. Any adverse effects were not detected in hematological test, serum biochemistry, and histopathological examination.

There are no specific tests or diagnostic criteria for herbinduced hepatic injury. Careful history taking, laboratory finding, and histopathology are used to diagnose it. The best way to determine causing agent is re-challenging. But it is not ethical and not applicable. Since patients usually do not regard dietary supplements as 'real' medicine, they may fail to mention it when physicians query medication history.

Physicians should keep in mind that dietary supplements can be the cause of hepatotoxicity when querying medication history, and should educate the lay public. There are three types of acute liver injury by drug or herb Our cases are characterized as hepatocellular; there is a predominant initial elevation of the ALT level.

There are two proposed pathogeneses of drug induced liver disease It is more likely that an idiosyncratic immunological mechanism hypersensitivity is responsible for the cases.

A role for hypersensitivity is further supported by the presence of eosinophilic granulocytes in the periportal fields seen in the biopsy. Hypersensitivity to aloe has been described in humans 14 , and the patch test or allergic skin test showed positive results Herb induced liver injury is an important problem in clinical setting, because it can be an etiology of undiagnosed acute hepatitis.

However, there are few available data about the incidence and clinical manifestation of dietary supplements such as aloe. Our cases emphasize that physicians should consider various dietary supplements as causative agents for hepatotoxicity.

Food and Drug Statistical Yearbook. Korea Food and Drug Administration. Aug, [accessed 0ct 27]. The survey for the actual condition of drug medication and development of health care cost associated with toxic liver injury in Korean: Acute hepatitis induced by an aloe vera preparation: Aloe vera-induced acute toxic hepatitis in a healthy young man.

Eur J Intern Med. Oral aloe vera-induced hepatitis. Criteria of drug-induced liver disorders. Report of an international consensus meeting. Vogler BK, Ernst E. Br J Gen Pract. Studies of the effectiveness and toxicity of aloe vera gel. The report of National Institute of Safety Research. Clinical features and diagnosis of drug induced liver injury. Pathologic features of toxic and drug induced liver injury.

A case of hypersensitivity associated with oral aloe agent. J Asthma Allergy Clin Immunol. Herbalife, Liver, Hepatotoxicity, Weight loss products, Dietary supplements.

Case 1 involved a patient who did not consume Herbalife products, while Cases 2 and 3 each reportedly consumed various Herbalife products.

Herbalife fundamentally disagrees with the conclusions made by the authors with regard to any cause and effect relationship related to the intake of Herbalife products. First, Herbalife is not a single product and no unique suspect product or ingredient has been implicated in this paper amongst the reported cases. In addition, the authors arbitrarily compared cases involving the use of a single product Hydroxycut with patients who consumed a group of totally unrelated products produced by the company Herbalife.

To bundle a brand of products such as Herbalife with another company that sells different products simply because they are all dietary supplements is not valid. Finally, there are specific considerations, in regard to the two patients who consumed Herbalife products, that would render many of the observations and conclusions discussed by the authors as speculative and unsubstantiated.

The specific and factual points supporting these views are further detailed below. Case 2 describes a year-old female who developed symptoms of abdominal pain, mild nausea, and painless jaundice 1 mo prior to presenting at the hospital[ 1 ]. We comply with the HONcode standard for trustworthy health information - verify here. Premature discontinuation of Xarelto increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including Xarelto, increases the risk of thrombotic events.

These events occurred during treatment or within 2 days of stopping treatment. Fatal bleeding is adjudicated death with the primary cause of death from bleeding. Although a patient may have had 2 or more events, the patient is counted only once in a category.

Xarelto 10 mg once daily or aspirin mg once daily. Major bleeding event 5 0. Patients may have more than one event. Data are shown for all randomized patients followed to site notification that the study would end. If the same patient had several events, the patient may have been counted for several components. The individual component of the primary endpoint represents the first occurrence of the event. Primary Composite Endpoint 13 1. NDC day starter blister pack containing 51 tablets: Medication Guide has been approved by the U.

Food and Drug Administration Revised: For people taking Xarelto for atrial fibrillation: People with atrial fibrillation an irregular heart beat are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. Xarelto lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking Xarelto, you may have increased risk of forming a clot in your blood.

Do not stop taking Xarelto without talking to the doctor who prescribes it for you. Stopping Xarelto increases your risk of having a stroke. If you have to stop taking Xarelto, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.

Xarelto can cause bleeding which can be serious, and rarely may lead to death. This is because Xarelto is a blood thinner medicine anticoagulant that reduces blood clotting. While you take Xarelto you are likely to bruise more easily and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take Xarelto and take other medicines that increase your risk of bleeding, including: Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding: People who take a blood thinner medicine anticoagulant like Xarelto, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move paralysis. Your risk of developing a spinal or epidural blood clot is higher if: Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness especially in your legs and feet , loss of control of the bowels or bladder incontinence.

Xarelto is not for people with artificial heart valves. Xarelto is a prescription medicine used to: With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body.

Do not take Xarelto if you: Talk to your doctor before taking Xarelto if you currently have unusual bleeding. See the end of this leaflet for a complete list of ingredients in Xarelto. Before taking Xarelto, tell your doctor about all of your medical conditions, including if you: It is not known if Xarelto will harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with Xarelto.

Taking Xarelto while you are pregnant may increase the risk of bleeding in you or in your unborn baby. If you take Xarelto during pregnancy tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See " What is the most important information I should know about Xarelto? Xarelto may pass into your breast milk. You and your doctor should decide if you will take Xarelto or breastfeed. Tell all of your doctors and dentists that you are taking Xarelto.

They should talk to the doctor who prescribed Xarelto for you before you have any surgery, medical or dental procedure. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way Xarelto works.

Certain medicines may increase your risk of bleeding. Take Xarelto exactly as prescribed by your doctor. Do not change your dose or stop taking Xarelto unless your doctor tells you to. Your doctor may change your dose if needed. If you take Xarelto for: Take Xarelto 1 time a day with your evening meal. If you miss a dose of Xarelto, take it as soon as you remember on the same day.

Take your next dose at your regularly scheduled time. Take Xarelto 1 or 2 times a day as prescribed by your doctor. For the 15 mg and 20 mg doses , Xarelto should be taken with food.

For the 10 mg dose , Xarelto may be taken with or without food. Take your Xarelto doses at the same times each day. If you miss a dose: Take Xarelto as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take Xarelto 1 time a day with or without food.

If you have difficulty swallowing the Xarelto tablet whole, talk to your doctor about other ways to take Xarelto. Your doctor will decide how long you should take Xarelto. Your doctor may stop Xarelto for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking Xarelto again after your surgery or procedure.

Do not run out of Xarelto. Refill your prescription of Xarelto before you run out. When leaving the hospital following a hip or knee replacement, be sure that you will have Xarelto available to avoid missing any doses.

If you take too much Xarelto, go to the nearest hospital emergency room or call your doctor right away. What are the possible side effects of Xarelto? How should I store Xarelto? Keep Xarelto and all medicines out of the reach of children. General information about the safe and effective use of Xarelto. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use Xarelto for a condition for which it was not prescribed. Do not give Xarelto to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Xarelto that is written for health professionals. What are the ingredients in Xarelto?

Finished Product Manufactured by: Titusville, NJ Licensed from: For more information call or go to www. Print this page Add to My Med List. Xarelto Rating User Reviews 6. Subscribe to free Drugs. FDA alerts for all medications. Treatment of DVT 2. Bleeding into a critical organ. Bleeding that required re-operation. General disorders and administration site conditions.

Musculoskeletal and connective tissue disorders. Skin and subcutaneous tissue disorders. Injury, poisoning and procedural complications. Components of Total VTE. Components of events contributing to Total VTE. Blister package containing tablets 10 blister cards containing 10 tablets each. Food and Drug Administration. What is the most important information I should know about Xarelto?

How should I take Xarelto? Part 1 of 2. VLCDs may not be nutritionally complete and provide far fewer calories than most people need to maintain a healthy weight. Our Superdrug Meal Replacement Shakes review team have stated that they do not think this product is good for long-term weight loss..

See our point here? We mentioned that short team weight loss success may be limited — by this we meal the following:. When you suddenly go from eating normally to only consuming liquid-calories per day, your body is going to quickly go into starvation mode. This means your metabolism will come to a screeching halt and the amount of weight you could potentially be losing will be very limited indeed.

Our top 10 best rated weight loss shakes based on effectiveness —. We have compiled the following list of potential side effects based on the ingredients used within the formula:. I bought this to help me loose a few pounds without the hassle of working out calories etc for lunch.

I am absolutely delighted with the shakes, the Chocolate flavor is completely yummy! Very quick to prepare and the individual sachets mean no measuring or mess.

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