Author Topic: Hydroxycut - FDA is recalling it and the analysis  (Read 10624 times)

Ruffneck

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Re: Hydroxycut being recalled!
« Reply #25 on: May 01, 2009, 11:10:44 AM »
I took 2 tablets of Hydroxycut back in 2003 and ended up with rhabdomyolysis and its the worst pain ive ever suffered. The average persons muscle enzyme levels are 200 and mine shot up to 21,000 and my kidneys almost packed up - I was in hospital for about 8 days and was not far away from kidney failiure.

I was convinced it was Hydroxycut that did it to me and now this confirms it.......I smell a lawsuit heading your way Muscletit.

Method101

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Re: Hydroxycut being recalled!
« Reply #26 on: May 01, 2009, 11:13:12 AM »
The only fatburner i would ever think about using is the one dave palumbo makes with his company... it would mainly be for curiosity as i have never dieted with one of them.

Nizar

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Re: Hydroxycut being recalled!
« Reply #27 on: May 01, 2009, 11:14:50 AM »
FUCKING MESS.

just ordered $250 worth of hydroxycut hardcore last month for summertime. will dump that shit in the garbage right now.

ordered ripped fuel 5 minutes ago. if that will be recalled, too, I'll probably soon have to liposuck my 43 year old sagging ass :-((



 :D

You could try to see if you can get a refund. May not happen but its worth a shot rather than trashing the lot

Ron

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Re: Hydroxycut being recalled!
« Reply #28 on: May 01, 2009, 11:17:46 AM »
Quote
At least 9 million packages were sold last year, the FDA said.


9 million Hydroxycuts... wow...

I would like to see the evidence that the FDA has concerning why they said all Hydroxycuts, since they are different, has to be recalled... 

Ruffneck

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Re: Hydroxycut being recalled!
« Reply #29 on: May 01, 2009, 11:18:45 AM »
Id be happy to give them all the information they need.

Matterhorn

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Re: Hydroxycut being recalled!
« Reply #30 on: May 01, 2009, 11:20:01 AM »
:D

You could try to see if you can get a refund. May not happen but its worth a shot rather than trashing the lot

already trashed it. ordered via vitaminshoppe.com. too little money to go through the hassle of getting a refund, for sure.

only thing that pisses me off, is that I used ripped fuel for many years (as I thought with good results) and only last month switched to hydroxyshit for some unknown reason.

which makes me feel kinda like the guy in the picture...

THEBOSS

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Re: Hydroxycut being recalled!
« Reply #31 on: May 01, 2009, 11:20:32 AM »
 ::) How about recalling all the products because of the rediculous claims ! Since their money is based on pure fraud shut the assholes down ! 8)

Nizar

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Re: Hydroxycut being recalled!
« Reply #32 on: May 01, 2009, 11:22:17 AM »
already trashed it. ordered via vitaminshoppe.com. too little money to go through the hassle of getting a refund, for sure.

only thing that pisses me off, is that I used ripped fuel for many years (as I thought with good results) and only last month switched to hydroxyshit for some unknown reason.

which makes me feel kinda like the guy in the picture...


Is ripped fuel that good. I've never tried using that stuff. Just relied on old fashioned cardio

Matterhorn

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Re: Hydroxycut being recalled!
« Reply #33 on: May 01, 2009, 11:28:58 AM »

Is ripped fuel that good. I've never tried using that stuff. Just relied on old fashioned cardio


I get more off a buzz, but also more of a dry mouth, from ripped fuel than I did from hydroxycrap these past weeks. but I always felt that ripped fuel helped me to get ready for the summer season (and during contest prep) to get down to less than 10 % body fat. it's extremely hard to get down to high single-digit bf levels naturally. so any little additional help is welcome.

Epic_Monster

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Re: Hydroxycut being recalled!
« Reply #34 on: May 01, 2009, 11:37:19 AM »
Spirit of Truth

Matterhorn

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Re: Hydroxycut being recalled!
« Reply #35 on: May 01, 2009, 11:42:23 AM »


unspectacular body for someone on prescription drugs. I am not impressed.

Nizar

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Re: Hydroxycut being recalled!
« Reply #36 on: May 01, 2009, 11:50:33 AM »
I get more off a buzz, but also more of a dry mouth, from ripped fuel than I did from hydroxycrap these past weeks. but I always felt that ripped fuel helped me to get ready for the summer season (and during contest prep) to get down to less than 10 % body fat. it's extremely hard to get down to high single-digit bf levels naturally. so any little additional help is welcome.

Is ripped fuel any better than ECA stack? I guess if you're dropping down to single digits you'd always on the lookout for the most effective product.

Matterhorn

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Re: Hydroxycut being recalled!
« Reply #37 on: May 01, 2009, 11:56:59 AM »
Is ripped fuel any better than ECA stack? I guess if you're dropping down to single digits you'd always on the lookout for the most effective product.

surely more effective, but ephedrine is no more an option for me:

http://www.getbig.com/boards/index.php?topic=276220.0

Nizar

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Re: Hydroxycut being recalled!
« Reply #38 on: May 01, 2009, 11:58:49 AM »
surely more effective, but ephedrine is no more an option for me:

http://www.getbig.com/boards/index.php?topic=276220.0

Interesting.
Thanks for the info/link

Ron

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Re: Hydroxycut being recalled!
« Reply #39 on: May 01, 2009, 12:18:55 PM »
Important Information Regarding
The Recent FDA Consumer Advisory
Friday May 1, 2009 12:30 PM EST

The U.S. Food and Drug Administration (FDA) recently released a consumer advisory about certain Hydroxycut-branded products. According to the advisory, the FDA has received 23 reports over the years about consumers having experienced serious liver-related problems coinciding with the time they were taking Hydroxycut-branded products. The advisory states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.”

While this is a small number of reports relative to the many millions of people who have used Hydroxycut products over the years, out of an abundance of caution and because consumer safety is our top priority, we are voluntarily recalling these Hydroxycut-branded products.

The information below answers questions consumers may have about the advisory, the recall, and Hydroxycut-branded products.

What is Hydroxycut?

Hydroxycut is the brand name of some of America’s top-selling weight loss products which are taken by millions of consumers each year. Hydroxycut products are made by Iovate Health Sciences, which has over 750 items sold in more than 70 countries around the world.

What steps do you take to ensure the safety of Hydroxycut-branded products?

We conduct internal analyses of individual ingredients, and undertake extensive medical, scientific and toxicological literature reviews on the safety of the ingredients during the development stage of each product. Additionally, third-party experts from the leading independent scientific firm specializing in ingredient assessment, toxicology and product safety for the nutritional and pharmaceutical industry review the safety of Iovate’s ingredients and formulas before products are introduced in the marketplace. Only after this external review is completed does Iovate release a formula.

What is an adverse event?

The term “adverse event” refers to any unexpected or unintended event that happens while an individual is taking a dietary supplement, whether or not the supplement caused the event. Even minor events can be considered adverse if they are unexpected or unintended.

Which products are covered by this advisory?

The following products are covered by the advisory:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Capsules
Hydroxycut Max Liquid Capsules
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Does the advisory say I should stop taking Hydroxycut-branded products?

Yes. The FDA’s advisory states that, “Consumers who have these products are urged to stop using them.”

What if I want to return my Hydroxycut product. How do I do that?

For product refunds, consumers are directed to return their product directly to the place of purchase.

Stormcloud

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Hydroxycut - did the FDA recall it based on this study?
« Reply #40 on: May 01, 2009, 12:30:57 PM »
Hydroxycut hepatotoxicity: A case series and review of liver toxicity from herbal weight loss supplements

Abstract - Dietary supplements represent an increasingly common source of drug-induced liver injury. Hydroxycut is a popular weight loss supplement which has previously been linked to hepatotoxicity, although the individual chemical components underlying liver injury remain poorly understood. We report two cases of acute hepatitis in the setting of Hydroxycut exposure and describe possible mechanisms of liver injury. We also comprehensively review and summarize the existing literature on commonly used weight loss supplements, and their individual components which have demonstrated potential for liver toxicity. An increased effort to screen for and educate patients and physicians about supplement-associated hepatotoxicity is warranted.

INTRODUCTION - Obesity has become an increasingly important public health problem in the United States. Recent data show that more than 30% of adults are obese and 65% overweight[1]. The use of dietary supplements for weight $55.4 billion spent in the U.S. in 2006 for weight loss and diet control[2,3]. Based on a study by the National Center for Complementary and Alternative Medicine (NCCAM), 36% of adults are using some form of complementary or alternative medicine, which rises to 62% when including megavitamins or prayer. Although dietary and herbal supplements are governed under the DSHEA act of 1994, they are not presently regulated by the U.S. Federal Drug Administration, and the safety profiles of many are unknown. An increasing number of case reports have emerged which suggest causative supplement-associated liver toxicity. Hydroxycut is an herbal weight loss supplement that has been suspected to have possible liver toxicity. Herein we present two patients who experienced severe acute hepatitis in the setting of documented Hydroxycut exposure, and without alternative etiology after comprehensive serologic liver evaluation.

CASE REPORTS

Case 1 - A 40-year-old female with a prior medical history notable only for hypothyroidism and diet-controlled hyperlipidemia presented to the Emergency Department with 3 d of new-onset crampy, mid-epigastric abdominal
pain and non-bloody diarrhea. She noted subjective fevers and chills, and two isolated episodes of nausea and
vomiting, anorexia and profound fatigue. She did not experience jaundice, icterus, pruritus, arthralgias, acholic
stools or dark urine. One week prior to presentation, she began using Hydroxycut, 6 pills daily in preparation for
a bodybuilding competition. Just prior to presentation she attended an office holiday party, although no other
persons in attendance became ill. She did not smoke or drink. She otherwise does not take regular medications
except for levothyroxine. She denied taking any other supplements or alternative medications. She was afebrile
with stable vital signs, and normal body mass index. Her exam was notable only for mild mid-epigastric tenderness to palpation. She had no liver enlargement and no stigmata of chronic liver disease. Her laboratory profile on admission revealed an acute hepatitis with AST 1020 U/L and ALT 1150 U/L, total bilirubin 0.67 mg/dL, alkaline phosphatase 299 U/L, INR 0.96, white cell count 5.9 × 103/μL, hemoglobin 11.9 g/dL, platelet count 228/μL, and creatinine 0.9 mg/dL. Diagnostic evaluation was negative for hepatitis A, B, C, cytomegalovirus and Epstein-Barr virus, autoimmune liver disorders (ANA, ASMA), alpha-1 anti-trypsin deficiency, and ehrlichiosis. On day 2 of admission, her transaminases decreased to AST 399 U/L and ALT 647 U/L. On day 3, she was clinically well and discharged from the hospital. Upon outpatient follow-up, she had returned to her usual state of health with normalization of transaminases with AST 46 U/L and ALT 48 U/L. She has not experienced any further recurrence of symptoms or liver abnormalities within 10 mo of follow-up.

Case 2 - A 33-year-old female with a prior medical history of a pituitary adenoma presented to the Emergency Department with 1 mo of new-onset jaundice. She reported a flu-like illness of 2 wk duration with nausea and crampy abdominal pain and began to experience jaundice, acholic stools, dark-colored urine, pruritus, and profound fatigue. These symptoms appeared to be improving during the week prior to admission except for worsening jaundice and fatigue. She noted that during the month prior to admission, she had taken Hydroxcut supplements for 2 wk to help achieve weight loss, but discontinued this medication upon onset of symptoms. She additionally reported eating lobster during the month prior to admission, but could not recall other individuals who became ill. Her only medication was Ortho-Novum contraceptive, which she had been taking for 2.5 years. Her social history was unremarkable without regular alcohol ingestion, and the absence of risk factors for chronic viral hepatitis. She was afebrile with stable vital signs, and normal body mass index. Her exam was notable only for jaundice and scleral icterus. She had no liver enlargement and no stigmata of chronic liver disease. Her laboratory profile at admission was notable for acute hepatitis with AST 934 U/L and ALT 1 570 U/L, total bilirubin 20.9 mg/dL, direct bilirubin 14.2 mg/dL, alkaline phosphatase 112 U/L, INR 1.08, white cell count 9.2 × 103/ěL, hematocrit 42%, platelet count 414/ěL, creatinine 0.8 mg/dL. Diagnostic evaluation was negative for hepatitis A, B, C, cytomegalovirus, Epstein-Barr virus, and herpes simplex virus infections. Her autoimmune profile revealed low titer increase in antinuclear antibody (ANA) and anti-smooth muscle antibody (ASMA) suggestive of an immune-mediated drug-induced hepatitis. Her jaundice eventually resolved and her liver function normalized.

Brutal_1

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Re: Hydroxycut - did the FDA recall it based on this study?
« Reply #41 on: May 01, 2009, 12:45:47 PM »


I still don't get the link between Hydroxycut and Liver problems  :-\

And that case report is a horrible one for a few reasons:

1. She already has a history of endocrine problems

2. History of bad diet and a high blood lipid could've ALREADY had a negative impact on the liver

3. "She denied taking any other supplements or alternative medications."  lol hmmmmmmmmmmmm  I heard a rumor once that bodybuilders used steroids, not sure if it's true.  but considering that she was preparing for a bodybuilding competition, I wouldn't put it past her.




I think the FDA should worry about bigger concerns like this Swine virus  ::) ;D  Or the Plasmosis epidemic  ::)
just not good enough

Howard

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Re: Hydroxycut - did the FDA recall it based on this study?
« Reply #42 on: May 01, 2009, 12:51:18 PM »

I still don't get the link between Hydroxycut and Liver problems  :-\

And that case report is a horrible one for a few reasons:

1. She already has a history of endocrine problems

2. History of bad diet and a high blood lipid could've ALREADY had a negative impact on the liver

3. "She denied taking any other supplements or alternative medications."  lol hmmmmmmmmmmmm  I heard a rumor once that bodybuilders used steroids, not sure if it's true.  but considering that she was preparing for a bodybuilding competition, I wouldn't put it past her.




I think the FDA should worry about bigger concerns like this Swine virus  ::) ;D  Or the Plasmosis epidemic  ::)

I have no real idea if this is legit and based on hard science or politics?
I do know that alcohol, butter and bacon have a definite impact of the health of anyone who overdoes it.
Hmmm, but no restrcitions on those things 'eh> hmmmmm

Stormcloud

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Re: Hydroxycut - did the FDA recall it based on this study?
« Reply #43 on: May 01, 2009, 12:52:13 PM »
DISCUSSION
 
The public’s increasing demand for alternative medicine, the newly found global interest in phytomedicine and herbal therapies, the rising cost of conventional prescription drugs, and a loss of faith in Western medicine, have led to a rapid rise in the use of unregulated herbal supplements and therapies. An estimated 80% of the world population uses herbal medicines, largely outside the U.S.[4]. In a study performed at an outpatient liver clinic, over 21% of patients were taking herbal supplements in the setting of chronic liver disease[5]. The FDA describes dietary supplements as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Most of these products have not been rigorously studied through placebo-controlled, blinded, randomized trials[6].

Hydroxycut is one of the most popular dietary supplements for weight loss on the market today, including two formulations Hydroxycut and Hydroxycut hardcore. Hydroxycut contains several different herbs, including: Garcinia Cambogia extract, chromium polynicotinate, Gymnema sylvestre extract and Camellia Sinenesis (C. Sinenesis) (Table 1). Both patients in this report used the dietary supplement Hydroxycut within a short time frame before presenting with acute hepatitis, suggesting Hydroxycut as the most likely etiology for acute liver injury. Neither patient had a history suggestive of other exposures or risk factors for viral hepatitis, alcoholic hepatitis, other toxinmediated injury, or chronic liver disease. A comprehensive serologic and radiographic evaluation performed in both patients did not reveal alternative sources for liver toxicity. Although causation is difficult to confirm in cases of suspected drug-associated hepatotoxicity, the temporal relationship to acute liver injury and rapid resolution upon withdrawal of Hydroxycut make this likely. Hydroxycut has previously been associated with both a cholestatic and hepatocellular pattern of injury. The specific components likely implicated in liver toxicity include G. Cambogia, Chromium, and green tea root extract (Camellia Sinensis) based on prior data suggesting liver toxicity. Patient 1 experienced a more typical hepatocellular pattern of injury, patient 2 demonstrated an immune-mediated pattern of injury, which has not previously been described.

There has been one prior report of two cases of possible hepatotoxicity with Hydroxycut in the literature[7]; both cases were young males who had documented periods of Hydroxycut exposure and experienced similar clinical syndromes marked by fatigue, jaundice, and pruritus with marked hepatocellular or cholestatic pattern and complete resolution upon supplement withdrawal. Our case series validates the likely causative relationship between Hydroxycut exposure and liver toxicity, and further suggests that an autoimmune pattern of hepatotoxicity may be observed. Although less common, drugassociated autoimmune hepatitis has been reported in several herbal supplements including Greater Celadine, Dai-Saiko-To, and Black Cohosh. Herein we review key ingredients of Hydroxycut that have been implicated in liver toxicity.

G. Cambogia is a fruit native to southeastern Asia and western Africa used to make meals more “filling”[8]. Its main component hydroxycitric acid (HCA) is an inhibitor of the citrate cleavage enzyme (ATP citrate lyase) blocking de novo synthesis of fatty acids[9]. HCA was initially studied in rodents for the dietary treatment of obesity and the results seemed to be promising. Unfortunately randomized controlled trials in humans for this purpose showed very conflicting results. Nevertheless, HCA is a primary component of many weight loss supplements in the market, and similar to others in its class, the toxicity profile is poorly studied. In the recent literature a case of fatal liver failure was reported in a patient taking HCA and monteleukast suggesting the synergistic hepatotoxic effect of these two agents[10]. There have also been reports of G. Cambogia toxicity by the WHO database, mostly describing an increase in hepatic enzymes[6].

Chromium is an essential trace element and cofactor to insulin most commonly occurring in hexavalent (‡Y) and trivalent (‡V) states. The hexavalent form is found in the dye and leather industry and is responsible for occupational toxicity ranging from dermatitis to lung cancer[11]. In 1989, the National Academy of Sciences established an “estimated safe and adequate daily dietary intake” range for chromium of 50 to 200 mg[12]. In 2001 the Institute of Medicine and the National Academy of Sciences established Dietary Reference Intakes (DRI) for Chromium, ranging from 0.2 mg for infants to a maximum of 45 mg in lactating mothers[13]. Chromium is used in weight loss supplements due to purported effects of decreasing body fat and increasing basal metabolic rate[14,15]. A recent meta-analysis of available RCTs concluded that weight reduction with chromium although statistically significant was not clinically meaningful[2]. There have been case reports of chromium toxicity causing acute hepatitis, thrombocytopenia and renal failure due to both environmental[16,17] and dietary supplements[18]. Although renal failure requiring dialysis is a more common concern[19], those presenting with liver toxicity frequently elaborate aminoteransferase elevations greater than 1000 mg/dL. Each Hydroxycut serving contains 133 mg of Chromium, which is taken three times daily, resulting in a cumulative daily consumption greater than twice the NAS safe maximum dose.

Camellia Sinensis is the scientific name for green tea, which is widely regarded by the public as safe, and commonly incorporated into supplements due to purported anti-cancer potential[20], weight reduction[21] and antioxidant properties[22]. Acute hepatotoxicity from C. Sinensis is well-described, and may range from acute hepatitis to acute liver failure. Based on 17 published cases in the literature[23-27], most cases appear to occur following large ingestions of green tea, with resolution following withdrawal, and recurrence with re-challenge[28]. Consequently, C. Sinesis has been banned in France and Spain, although it remains unregulated in weight loss supplements commercially available in the U.S.

Other Hydroxycut components for which liver toxicity have not been described include Gymnema Sylvestre, Rhodiola Rosea, and Withania Somnifera. Gymnema Sylvestre has been used to control hyperglycemia[29] and hyperlipidemia[30] in rats. Toxicity studies in rodents have not shown hepatotoxicity[31] and no case report of liver injury has been reported. Rhodiola Rosea extract is used to decrease fatigue[32] and improve exercise tolerance[33]. Withania Somnifera has been used for its anti-inflammatory properties[34,35]. Neither R Rosea or W Somnifera have been associated with liver toxicity, although W Somnifera may result in renal impairment in rats[36].

Of note, the more concentrated Hydroxycut HardCore product contains additional herbal formulations such as White Willow extract and Yohimbine. These have not been demonstrated to result in liver injury, whereas Willow bark extract may have anti-inflammatory effects in vitro, this was not observed in patients with rheumatoid arthritis or osteoarthritis in a randomized controlled trial[37]. Yohimbine is an indole alkaloid from the bark of the African Pausinystalia Yohimbe, and serves as an alpha-2 receptor antagonist which may treat male impotence[38]. Although nausea, vomiting and abdominal pain have been described, liver toxicity has not been observed.

The FDA has issued warnings on several herbal supplements known to have hepatotoxic potential including Comfrey (2001), Kava (2002) and the dietary supplement Lipokinetix (2001). This review does not seek to provide a comprehensive review of all known hepatotoxins, but highlight a short list of ingredients within best selling weight loss supplements which have been demonstrated to have hepatotoxic potential.

MattT

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Re: Hydroxycut - did the FDA recall it based on this study?
« Reply #44 on: May 01, 2009, 12:52:58 PM »
wow i just saw this on the front page of yahoo.com


FDA warns dieters: Stop Hydroxycut use immediately
http://health.yahoo.com/news/ap/us_med_diet_pill_recall.html

Brutal_1

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Re: Hydroxycut - did the FDA recall it based on this study?
« Reply #45 on: May 01, 2009, 12:53:58 PM »
DISCUSSION
 
The public’s increasing demand for alternative medicine, the newly found global interest in phytomedicine and herbal therapies, the rising cost of conventional prescription drugs, and a loss of faith in Western medicine, have led to a rapid rise in the use of unregulated herbal supplements and therapies. An estimated 80% of the world population uses herbal medicines, largely outside the U.S.[4]. In a study performed at an outpatient liver clinic, over 21% of patients were taking herbal supplements in the setting of chronic liver disease[5]. The FDA describes dietary supplements as a product taken
by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these
products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes,
organ tissues, glandulars, and metabolites. Most of these products have not been rigorously studied through placebo-controlled, blinded, randomized trials[6].

Hydroxycut is one of the most popular dietary supplements for weight loss on the market today, including two formulations Hydroxycut and Hydroxycut hardcore. Hydroxycut contains several different herbs, including: Garcinia Cambogia extract, chromium polynicotinate, Gymnema sylvestre extract and Camellia Sinenesis (C. Sinenesis) (Table 1). Both patients in this report used the dietary supplement Hydroxycut within a short time frame before presenting with acute hepatitis, suggesting Hydroxycut as the most likely etiology for acute liver injury. Neither patient had a history suggestive of other exposures or risk factors for viral hepatitis, alcoholic hepatitis, other toxinmediated injury, or chronic liver disease. A comprehensive serologic and radiographic evaluation performed in both patients did not reveal alternative sources for liver toxicity. Although causation is difficult to confirm in cases of suspected drug-associated hepatotoxicity, the temporal relationship to acute liver injury and rapid resolution upon withdrawal of Hydroxycut make this likely. Hydroxycut has previously been associated with both a cholestatic and hepatocellular pattern of injury. The specific components likely implicated in liver toxicity include G. Cambogia, Chromium, and green tea root extract (Camellia Sinensis) based on prior data suggesting liver toxicity. Patient 1 experienced a more typical hepatocellular pattern of injury, patient 2 demonstrated an immune-mediated pattern of injury, which has not previously been described.

There has been one prior report of two cases of possible hepatotoxicity with Hydroxycut in the literature[7]; both cases were young males who had documented periods of Hydroxycut exposure and experienced similar clinical syndromes marked by fatigue, jaundice, and pruritus with marked hepatocellular or cholestatic pattern and complete resolution upon supplement withdrawal. Our case series validates the likely causative relationship between Hydroxycut exposure and liver toxicity, and further suggests that an autoimmune pattern of hepatotoxicity may be observed. Although less common, drugassociated autoimmune hepatitis has been reported in several herbal supplements including Greater Celadine, Dai-Saiko-To, and Black Cohosh. Herein we review key ingredients of Hydroxycut that have been implicated in liver toxicity.

G. Cambogia is a fruit native to southeastern Asia and western Africa used to make meals more “filling”[8]. Its main component hydroxycitric acid (HCA) is an inhibitor of the citrate cleavage enzyme (ATP citrate lyase) blocking de novo synthesis of fatty acids[9]. HCA was initially studied in rodents for the dietary treatment of obesity and the results seemed to be promising. Unfortunately randomized controlled trials in humans for this purpose showed very conflicting results. Nevertheless, HCA is a primary component of many weight loss supplements in the market, and similar to others in its class, the toxicity profile is poorly studied. In the recent literature a case of fatal liver failure was reported in a patient taking HCA and monteleukast suggesting the synergistic hepatotoxic effect of these two agents[10]. There have also been reports of G. Cambogia toxicity by the WHO database, mostly describing an increase in hepatic enzymes[6].

Chromium is an essential trace element and cofactor to insulin most commonly occurring in hexavalent (‡Y) and trivalent (‡V) states. The hexavalent form is found in the dye and leather industry and is responsible for occupational toxicity ranging from dermatitis to lung cancer[11]. In 1989, the National Academy of Sciences established an “estimated safe and adequate daily dietary intake” range for chromium of 50 to 200 mg[12]. In 2001 the Institute of Medicine and the National Academy of Sciences established Dietary Reference Intakes (DRI) for Chromium, ranging from 0.2 mg for infants to a maximum of 45 mg in lactating mothers[13]. Chromium is used in weight loss supplements due to purported effects of decreasing body fat and increasing basal metabolic rate[14,15]. A recent meta-analysis of available RCTs concluded that weight reduction with chromium although statistically significant was not clinically meaningful[2]. There have been case reports of chromium toxicity causing acute hepatitis, thrombocytopenia and renal failure due to both environmental[16,17] and dietary supplements[18]. Although renal failure requiring dialysis is a more common concern[19], those presenting with liver toxicity frequently elaborate aminoteransferase elevations greater than 1000 mg/dL. Each Hydroxycut serving contains 133 mg of Chromium, which is taken three times daily, resulting in a cumulative daily consumption greater than twice the NAS safe maximum dose.

Camellia Sinensis is the scientific name for green tea, which is widely regarded by the public as safe, and commonly incorporated into supplements due to purported anti-cancer potential[20], weight reduction[21] and antioxidant properties[22]. Acute hepatotoxicity from C. Sinensis is well-described, and may range from acute hepatitis to acute liver failure. Based on 17 published cases in the literature[23-27], most cases appear to occur following large ingestions of green tea, with resolution following withdrawal, and recurrence with re-challenge[28]. Consequently, C. Sinesis has been banned in France and Spain, although it remains unregulated in weight loss supplements commercially available in the U.S.

Other Hydroxycut components for which liver toxicity have not been described include Gymnema Sylvestre, Rhodiola Rosea, and Withania Somnifera. Gymnema Sylvestre has been used to control hyperglycemia[29] and hyperlipidemia[30] in rats. Toxicity studies in rodents have not shown hepatotoxicity[31] and no case report of liver injury has been reported. Rhodiola Rosea extract is used to decrease fatigue[32] and improve exercise tolerance[33]. Withania Somnifera has been used for its anti-inflammatory properties[34,35]. Neither R Rosea or W Somnifera have been associated with liver toxicity, although W Somnifera may result in renal impairment in rats[36].

Of note, the more concentrated Hydroxycut HardCore product contains additional herbal formulations such as White Willow extract and Yohimbine. These have not been demonstrated to result in liver injury, whereas Willow bark extract may have anti-inflammatory effects in vitro, this was not observed in patients with rheumatoid arthritis or osteoarthritis in a randomized controlled trial[37]. Yohimbine is an indole alkaloid from the bark of the African Pausinystalia Yohimbe, and serves as an alpha-2 receptor antagonist which may treat male impotence[38]. Although nausea, vomiting and abdominal pain have been described, liver toxicity has not been observed.

The FDA has issued warnings on several herbal supplements known to have hepatotoxic potential including Comfrey (2001), Kava (2002) and the dietary supplement Lipokinetix (2001). This review does not seek to provide a comprehensive review of all known hepatotoxins, but highlight a short list of ingredients within best selling weight loss supplements which have been demonstrated to have hepatotoxic potential.



Okay, that makes more sense....thanks!  ;)
just not good enough

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Re: Hydroxycut being recalled!
« Reply #46 on: May 01, 2009, 12:55:02 PM »
At least people can still get whisky and advil!

MattT

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Re: Hydroxycut being recalled!
« Reply #47 on: May 01, 2009, 01:00:02 PM »
could this bankrupt Muscletech?  isn't that their # 1 selling product?.  And what are all their athletes going to say now?

Matterhorn

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Re: Hydroxycut being recalled!
« Reply #48 on: May 01, 2009, 01:02:35 PM »
yes, well

I guess, once that damaged liver has been removed, the sun will shine again...    :-X

Stormcloud

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Re: Hydroxycut - did the FDA recall it based on this study?
« Reply #49 on: May 01, 2009, 01:04:22 PM »
MORE DISCUSSION

Ephedra alkaloid, AKA Ma Huang, is the most commonly used weight loss supplement in the U.S.[4], and is well-known to have potentially deleterious cardiovascular and CNS effects[39], but has also been implicated in numerous cases of liver failure[40,41]. As such, dietary supplements containing ephedra were banned in the U.S. in April 2004[42], but remain widely available through unregulated internet sources in various forms, including the supplement Leptoprin (previously Anorex) which contains 20 mg of ephedrine, 200 mg of caffeine, 324 mg of aspirin, and unknown amounts of Green tea and cayenne. Adipokinitex came to the market to replace Lipokinetix which was removed in 2002 by Syntrax Innovations Inc. due to FDA  warnings regarding reported cases of hepatotoxicity[43]. Although the Usnic acid has been removed from the formulation, this diet pill still contains Norephedrine or Norphenephrine and Green tea extracts. Ephedrasil Hardcore, a top selling diet pill, is a newer formulation of Ephedra following its ban in 2004, and contains many ingredients including Chromium, Yohimbine, and green tea extract.

Hoodia Gordoni, a popular supplement used for appetite suppression, and is derived from a cactus-like bush leaf native to southern Africa. Although initially isolated by Pfizer in the 1970s, research was discontinued due to liver toxicity found in early research studies. Despite these reports, this is a common ingredient in dietary supplements such as Slim-Citi, Trim Spa X32 and Ephedrine-P57.

Zalestrim is another top selling supplement composed of green tea and Black Cohosh, which are described above as known sources of potential hepatotoxicty[44-48]. It also contains Dong Quai, which increases prothrombin time and thereby increases bleeding risk[49].

In summary, this case series and review of the literature highlight the potential hepatotoxicity of commonly used herbal supplements including Hydroxycut. Due to their loose regulation in the current drug marketplace, oversight of their use by physicians and regulators alike remains poor. Those supplements with potential liver toxicity are summarized in Tables 2 and 3, although further investigation is needed to better clarify the mechanisms and patterns of injury, and inform policy makers on those ingredients which require more vigorous regulation. The use of supplements is frequently not queried by physicians, and may not be reported in the same manner as prescription drugs by patients. As such, it is advisable that physicians ask specifically about the use of non-prescription drugs and supplements, warn patients with known liver disease about the potential consequences of their use, and to query patients specifically about possible supplement exposure in cases of acute or chronic liver injury. Increased attention to this issue by physicians and regulatory agencies may lead to more successful efforts to decrease the burden of drugassociated liver injury in the U.S.