Getbig Bodybuilding, Figure and Fitness Forums
Getbig Main Boards => Gossip & Opinions => Topic started by: TK on May 01, 2009, 09:34:49 AM
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FDA Warns Consumers to Stop Using Hydroxycut Products
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.
Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:
Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
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
Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.
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Americas #1 selling fat burner!
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I'm amazed that product did "anything"
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Yeah, just saw this. Wonder how many cases of liver failure were actually directly attributed to this product. 23 reported out of millions of users?
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Americas #1 selling fat burner!
It accounts for about 90 percent of the market for weight loss supplements, with sales of about 1 million bottles a year. Damn...
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Omg what is going to happen to Dexter if he can`t take Hydroxycut Hardcore??? No way he can win the O.
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Much safer to stick with time-proven drugs like ephedrine and caffeine. The safety profiles are much more well established.
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Manufacturers don't need to prove to the FDA that their products are safe and effective before they can sell them to consumers.
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1 million+ bottles a year, 23 cases in a number of years that people that use the product, along with what else did they use that they didnt say. How many actually because of Hydroxycut???
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Manufacturers don't need to prove to the FDA that their products are safe and effective before they can sell them to consumers.
from another AP article:
Health officials said they have been unable to determine which Hydroxycut ingredients are potentially toxic, partially because the formulation of the products has changed several times. A medical journal report last month raised questions about one ingredient, hydroxycitric acid, derived from a tropical fruit. The article said it could potentially damage the liver.
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is this 56.626262% more harmful to your liver than regular hydroxycut?
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Users of steroids alone suffered no liver damage. The FDA is sure it's the Hydroxcut. Muscletech = Serious business
Had they taken Plazmosis, they would have had improved liver functions and/or grown a new liver.
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1 million+ bottles a year, 23 cases in a number of years that people that use the product, along with what else did they use that they didnt say. How many actually because of Hydroxycut???
Who knows what role the supps played but would you give this to your wife for example, after reading this report?
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U.S. government health officials warned dieters and body builders Friday to immediately stop using Hydroxycut, a widely sold Canadian-made supplement linked to cases of serious liver damage and at least one death.
The Food and Drug Administration said the maker of the dietary supplement has agreed to recall 14 Hydroxycut products. Available in grocery stores and pharmacies, Hydroxycut is advertised as made from natural ingredients. At least 9 million packages were sold last year, the FDA said.
Dr. Linda Katz of the FDA's food and nutrition division said the agency has received 23 reports of liver problems, including the death of a 19-year-old boy living in the Southwest. The teenager died in 2007, and the death was reported to the FDA this March.
Katz said it has taken so long to get a handle on the Hydroxycut problem because the cases of liver damage were rare and the FDA has no authority to review supplements before they're marketed. "Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow," she said
Health officials said they have been unable to determine which Hydroxycut ingredients are potentially toxic, partially because the formulation of the products has changed several times. A medical journal report last month raised questions about one ingredient, hydroxycitric acid, derived from a tropical fruit. The article said it could potentially damage the liver.
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from another AP article:
Health officials said they have been unable to determine which Hydroxycut ingredients are potentially toxic, partially because the formulation of the products has changed several times. A medical journal report last month raised questions about one ingredient, hydroxycitric acid, derived from a tropical fruit. The article said it could potentially damage the liver.
Hydroxycut Hardcore doesn't have HCA (ironically enough). Plus, wouldn't people be dropping from use of other products, if HCA were the culprit?
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FDA announces recall of weight loss pill Hydroxycut
U.S. government health officials are warning dieters and body builders to immediately stop using Hydroxycut, a diet supplement made in Canada that has been linked to serious liver damage and at least one death.
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FDA announces recall of weight loss pill Hydroxycut
U.S. government health officials are warning dieters and body builders to immediately stop using Hydroxycut, a diet supplement made in Canada that has been linked to serious liver damage and at least one death.
Brutal late post. :o
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noob
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Thank God for Johnny Falcon and his weight loss advices! :D
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1 million+ bottles a year, 23 cases in a number of years that people that use the product, along with what else did they use that they didnt say. How many actually because of Hydroxycut???
The FDA unwritten rule is if they see 3 cases out of 1000 doses/users, than it is a public concern (Bert Spilker's Guide to Clinical Trials).
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lol at "liver injury" ;D
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Some where Christian Boeving is smiling! :D
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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 :-((
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I have never used "Fat burning pills" or ever will
not needed at all, don't work and are dangerous
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If I wanted liver failure,
I'd take 10 anadrol 50 a day
but reap some benefits!
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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.
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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.
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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
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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...
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Id be happy to give them all the information they need.
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: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...
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::) How about recalling all the products because of the rediculous claims ! Since their money is based on pure fraud shut the assholes down ! 8)
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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
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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.
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unspectacular body for someone on prescription drugs. I am not impressed.
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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.
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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
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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
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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.
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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/ìL, hematocrit 42%, platelet count 414/ìL, 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.
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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 ::)
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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
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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.
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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
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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! ;)
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At least people can still get whisky and advil!
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could this bankrupt Muscletech? isn't that their # 1 selling product?. And what are all their athletes going to say now?
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yes, well
I guess, once that damaged liver has been removed, the sun will shine again... :-X
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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.
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http://www.google.com/hostednews/ap/article/ALeqM5ijbVgN_ATciR3vPd7y0t41vtzKLgD97TKU980
http://www.hydroxycutinformation.com/
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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.
::)
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156% more deadly than swine flu.
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People who use it deserve to be ill anyway..
Buys caffeine pills from the local drug store along with some Bronkaid and you are good to go!
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::)
all of a sudden they are the heroes.. of cause they are.
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http://www.google.com/hostednews/ap/article/ALeqM5ijbVgN_ATciR3vPd7y0t41vtzKLgD97TKU980
http://www.hydroxycutinformation.com/
I think only the non Hardcore stuff is fake. All the hardcore ones work. I am proof!!!!
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As you know, Iovate is strongly committed to product safety. In keeping with that mission, Iovate
welcomes balanced regulation for the dietary supplement industry, and we feel that these
regulations are in the best interest of our customers and our industry.
Millions of consumers purchase Hydroxycut products each year. Iovate carefully considers the
ingredients in each of its dietary supplement formulations to make sure that they are safe. Each
ingredient in each formulation is investigated for safety by reviewing all of the available medical,
scientific, and toxicological information that is publicly available. Iovate works closely with
nutritional scientists and other scientists, both within and outside of the company, to develop its
products. A world-renowned, independent third-party expert toxicological firm reviews all
formulas Iovate launches for safety, before launch. Iovate does not release any product
containing any ingredient that it has not evaluated for safety. In addition, once an Iovate product
is made available to consumers, Iovate continues to monitor the safety of the product by
collecting information on potential adverse experiences with the product.
Iovate initiated a voluntary recall when it became aware that the U.S. Food and Drug
Administration’s analysis of 23 reports over the last seven years about consumers having
experienced liver-related problems was different than the analysis done by Iovate’s independent,
third-party toxicological experts and epidemiologists. On May 1, 2009, the FDA issued an
advisory which states that, “Although the liver damage appears to be relatively rare, FDA believes
consumers should not be exposed to unnecessary risk.” In 2008, for instance, more than 9
million units of Hydroxycut-branded products were sold, while the FDA only referred to three
reports potentially associating the products with liver toxicity.
Iovate’s own assessment of the potential risk associated with the use of these products differs
from that expressed by the Agency. For instance, the number of adverse event reports described
by the FDA is small relative to the many millions of people who have used Hydroxycut products
over the seven years referenced by the FDA. These numbers must be contrasted with the
background rate of 1 in 100,000 for hepatitis/liver injury in the general population. Kaplowitz N.
2005, Idiosyncratic Drug Hepatotoxicity, Nature Review Drug Discovery, June 4 (6); 489-99.
Moreover, Dr. David Graham of the FDA reviewed data from four epidemiology studies and
estimated that the rate of idiopathic (i.e., unexplained) acute liver failure is approximately one per
million per year. Graham, D., American Journal of Gastroenterology 2003; 98: 175-179.
However, out of an abundance of caution and because consumer safety is Iovate’s top priority,
Iovate is voluntarily recalling these Hydroxycut-branded products in the United States. Please
note that Hydroxycut Hoodia and Cleanse products are not included in this recall; nor are any
other Iovate products. We are working with the FDA in this recall process. We will be in contact
with you very shortly to effectuate this recall.
This voluntary Class 2 recall applies to the following:
- Hydroxycut Regular Rapid Release Caplets
- Hydroxycut Caffeine-Free Rapid Release Caplets
- Hydroxycut Hardcore Liquid Caplets
- Hydroxycut Max Liquid Caplets
- 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
As you have already heard, the new evolution in the Hydroxycut brand, Hydroxycut Advanced,
will be shipping in the near future. You should have received a Hydroxycut Advanced information
deck by now, but if you haven’t, please contact your Iovate authorized broker or your Iovate Sales
Team member as it is critical that your orders are in place soon. We expect initial demand might
exceed our ability to supply the new formulations, at least in the beginning.
Over the last ten years, the Hydroxycut brand has been the top selling weight loss supplement
brand in the U.S. During this time, we have continuously reformulated our product offerings. Our
new formula, Hydroxycut Advanced, while also based on science, is a completely new and
revolutionary formulation.
We thank you for your continued support and we look forward to working closely with you.
Sincerely,
Iovate Health Sciences
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I think only the non Hardcore stuff is fake. All the hardcore ones work. I am proof!!!!
it works, as long as you're OK crapping out your liver.
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Never took it anyway... based on liver/kidney damage one could take almost any supplement away.
Sorry, that was a "blanket statement"... and far from the truth....nevertheless; ban em all!
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it works, as long as you're OK crapping out your liver.
haha, yea idiots who take muscletech are even dumber than juicers.
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haha, yea idiots who take muscletech are even dumber than juicers.
Are you suggesting that Jay Cutler did not win Mr. Olympia because of the MuscleTech Jay Cutler stack?
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it works, as long as you're OK crapping out your liver.
Come to think of it,, my liver's been bothr' :on me.
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Are you suggesting that Jay Cutler did not win Mr. Olympia because of the MuscleTech Jay Cutler stack?
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That's alot of Hydroxycut. :o
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No he won it initially from having diarrhea before stepping on stage in 06.
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i was watching Hardball on MSNBC as usually do at this time and i noticed something scroll across the bottom of the screen
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..
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There is many cases not reported, or where the connection to Hydroxycut was not realized, as stated in the news. Plus many people walking around with damaged livers that does not realize it or what it is from. So 23 clear cases it more than enough to pull it.
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Is justice finally in the cards for HustleTech? Let's hope.
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Who knows what role the supps played but would you give this to your wife for example, after reading this report?
Bump for Ron
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Anyone ever heard of diet and cardio? All of these snake oils salesmen use the same and tried formula. Use a guys using steroids as their after picture. Steroids work not these supplements with their phony clinical trials conducted in Bulgaria.
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Do they have any actual proof on this?
I heard one guy "MAY" have died because of the product. Once again, it's the same thing with the media. One death that MAY be related to the product...let's discount the MILLIONS who take it and have no problem.
Fucking pathetic.
BAN Hydroxycut
SELL Cigarettes
How backwards is our government?
Use this, but don't use this.
Use this, but we're going to tax the hell out of it.
Tools. ;)
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The FDA has issued a statement claming that hydroxycut causes liver damage. check CNN for the full story.
It is suggested to cease using the product
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I saw that too. Fortunately, I don't use "supplements". If you want a weight-loss aid, try ephedrine, cytomel, or clen, not the BS the mags push.
Hope this helps.
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thank you for the 25,658,696,334,478th thread about this today.
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Do they have any actual proof on this?
I heard one guy "MAY" have died because of the product. Once again, it's the same thing with the media. One death that MAY be related to the product...let's discount the MILLIONS who take it and have no problem.
Fucking pathetic.
BAN Hydroxycut
SELL Cigarettes
How backwards is our government?
Use this, but don't use this.
Use this, but we're going to tax the hell out of it.
Tools. ;)
Have you used Hydroxycut?
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you couldn't be more welcome!! salutations my friend
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1 million+ bottles a year, 23 cases in a number of years that people that use the product, along with what else did they use that they didnt say. How many actually because of Hydroxycut???
:D you seem like a good guy RON but we all know why your supporting this scam called TECH ! Maybe you should just say nothing ? These guys are RICh based on bullshit ! which is basically steeling from kids ! ::)
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Users of steroids alone suffered no liver damage. The FDA is sure it's the Hydroxcut. Muscletech = Serious business
Had they taken Plazmosis, they would have had improved liver functions and/or grown a new liver.
BTW anyone know if there's any rule forbidding me selling my spare liver here?
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Hydroxycuts is a goyim scam!
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Plazmosis taken by you will cause liver failure in others.
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http://consumerist.com/5236010/recall-fda-warns-consumers-to-stop-using-hydroxycut-immediately?skyline=true&s=x
http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html
Fucking shit, if i wanted to risk me liver i would use juice! >:(
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http://consumerist.com/5236010/recall-fda-warns-consumers-to-stop-using-hydroxycut-immediately?skyline=true&s=x
Fucking shit, if i wanted to risk me liver i would use juice! >:(
All this time. We never knew damn it!
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Fuck hydrocut I'm switching to lipo 6. I'm going to gnc tomorrow and throw the pills on the sells person. It is going to rock. :D
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I have never used "Fat burning pills" or ever will
not needed at all, don't work and are dangerous
They do work and work very well if you follow a sensible diet and exercise routine.They could be dangerous if you are predisposed to certain ailments like 23 people out of 9 million
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fat burners are unnecessary anyway
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Who knows what role the supps played but would you give this to your wife for example, after reading this report?
you know what. sure i would. because i highly doub that there is anything at all in hydroxycut that would cause anything like this to happen. read the ingredient listing. soemthing are just common sense. sounds to me like some people who coincidentally got sick at the same tim thtey tried some hydroxy just want to cash in on the $giant that is iovate.
Do they have any actual proof on this?
I heard one guy "MAY" have died because of the product. Once again, it's the same thing with the media. One death that MAY be related to the product...let's discount the MILLIONS who take it and have no problem.
Fucking pathetic.
BAN Hydroxycut
SELL Cigarettes
How backwards is our government?
Use this, but don't use this.
Use this, but we're going to tax the hell out of it.
Tools. ;)
i agreee 100%
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you know what. sure i would. because i highly doub that there is anything at all in hydroxycut that would cause anything like this to happen. read the ingredient listing. soemthing are just common sense. sounds to me like some people who coincidentally got sick at the same tim thtey tried some hydroxy just want to cash in on the $giant that is iovate.
I'm just extra careful with loved ones. The possible hepatotoxic ingredients are Chromium (high dose), Green Tea extract and Hydroxycitric Acid. They have been shown to be possibly liver toxic in other studies.
23 Abu el Wafa Y, Benavente Fernandez A, Talavera Fabuel
A, Perez Ramos MA, Ramos-Clemente JI. [Acute hepatitis
induced by Camellia sinensis (green tea)] An Med Interna
2005; 22: 298
24 Duenas Sadornil C, Fabregas Puigtio S, Durandez R.
[Hepatotoxicity due to Camelia sinensis] Med Clin (Barc)
2004; 122: 677-678
25 Garcia-Moran S, Saez-Royuela F, Gento E, Lopez Morante
A, Arias L. [Acute hepatitis associated with Camellia thea
and Orthosiphon stamineus ingestion] Gastroenterol Hepatol
2004; 27: 559-560
26 Gloro R, Hourmand-Ollivier I, Mosquet B, Mosquet L,
Rousselot P, Salame E, Piquet MA, Dao T. Fulminant
hepatitis during self-medication with hydroalcoholic extract
of green tea. Eur J Gastroenterol Hepatol 2005; 17: 1135-1137
27 Molinari M, Watt KD, Kruszyna T, Nelson R, Walsh M,
Huang WY, Nashan B, Peltekian K. Acute liver failure
induced by green tea extracts: case report and review of the
literature. Liver Transpl 2006; 12: 1892-1895
28 Bonkovsky HL. Hepatotoxicity associated with supplements
containing Chinese green tea (Camellia sinensis). Ann Intern
Med 2006; 144: 68-71
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Because that is more ammunition for the government to make even vitaminas and minerals
need to go through govt approval. Its like that in alot of countries, where you can't even
get aspirin without a rx, as well as "high dosed" multi-vitamins. Next thing you know,
Protein powder will neeed govt approval, they tried this like 10 years ago.
You still can't get tryptophan in singular form like you used to.
As well as the Old awesome ripped fuel pre ephedra ban.
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All national institutions of churches, whether Jewish,
Chris tian or Turkish, appear to me no other than human
inventions, set up to terrify and enslave mankind, and
monopolize power and profi t.
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You still can't get tryptophan in singular form like you used to.
You can. Google it.
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Nice study, but which formula are they talking about here? The new one, the one from 2007? Pretty much each Hydroxycut is different in various ways, so if the FDA says all cause liver damages, what exactyl is the proof?
Many people have asked me that in the last day.
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http://www.cnn.com/2009/HEALTH/05/01/hydroxycut.fda.recall/index.html (http://www.cnn.com/2009/HEALTH/05/01/hydroxycut.fda.recall/index.html)
-
:o
FDA Warns Consumers to Stop Using Hydroxycut Products
Posted in News, Supplements on May 1st, 2009
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.
Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:
Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
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
Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.
-
Wow thanks I've never read about this before.
-
:o
FDA Warns Consumers to Stop Using Hydroxycut Products
Posted in News, Supplements on May 1st, 2009
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.
Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:
Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
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
Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.
is this thread 189234513491347% more accurate than the previous?
I have "built muscle and lost some fat" while reading it.
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is this thread 189234513491347% more accurate than the previous?
I have "built muscle and lost some fat" while reading it.
you definatly have entered an anabolic state :D
-
you definatly have entered an anabolic state :D
just by reading about Muscletech... ;D
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This just in , the titanic sunk :D
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Jay finally beat Ronnie!!!!
-
:o
FDA Warns Consumers to Stop Using Hydroxycut Products
Posted in News, Supplements on May 1st, 2009
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.
Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:
Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
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
Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.
::) Hi BSN Products ::)
;D
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Hydryoxycut will now be out of business.
They don't know why or what ingrediant
this is attributed to? All hydroxycut stuff will
not be able to be sold then.
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i went to gnc with half a bottle of hc hardcore today. they give me 35 bucks store credit plus i used that $5 gnc dollar coupon gnc is mailing to everyone. So i got lipo 6 black for 19 bucks. Gnc is loving this. They return the product to the company for a full refund, plus the 20 so bucks the make with the refund. Plus every has to buy a fat burner again. And they email 5 buck coupons to everyone so they don't lose sells.
gnc is turning a frown upside down, and cashing out.
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This just in , the titanic sunk :D
the FDA just ass raped them.
lol, they should have spent some of that "millions of dollars on research" on testing. :D
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Nice study, but which formula are they talking about here? The new one, the one from 2007? Pretty much each Hydroxycut is different in various ways, so if the FDA says all cause liver damages, what exactyl is the proof?
Many people have asked me that in the last day.
The FDA did NOT say it causes liver damage for sure. They saw an association and alerted the public. MT voluntarily recalled the product, from what I can see.
If the FDA were concerned and did nothing, we would all be furious if it did cause problems in some, which the FDA knew, yet did nothing.
Same thing with the Syntrax Lipokinetix that was pulled years ago. It was liver toxic for sure.
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hydroxyshit
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Hydryoxycut will now be out of business.
They don't know why or what ingrediant
this is attributed to? All hydroxycut stuff will
not be able to be sold then.
They may rebrand and put it back on the shelves
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They may rebrand and put it back on the shelves
New Hydroxycut Hardcore X and Hydroxycuy Advanced will be out within a few weeks. Amazing how people get scared over this...
Here is a most recent blog by Jerry Brainum over this issue..
Is Hydroxycut really dangerously toxic?
The FDA announced today the recall of a dietary supplement touted for fat loss called Hydroxycut. This is a heavily advertised and popular supplement among bodybuilders and others. I received two e-mails shortly after the FDA announcement about the Hydroxycut recall. Here was my response:
In the most recent study, a case study is presented about a 28-year-old man who showed symptoms indicative of severe liver toxicity. He had ingested Hydroxycut according to product directions, ingesting 2 tablets, 2-3 times daily for 3 months prior to the onset of his symptoms. He also ingested Tylenol and aspirin to treat his “sore muscles.” The man also admitted to drinking an average of 2-3 beers a week, which was described by the study authors as “heavy drinking.” The man showed a high copper level in his urine, which could be indicative of a genetic disease called Wilson’s disease that is characterized by high copper levels. But this was ruled out by the finding of normal serum copper and ceruloplasmin (the protein carrier of copper in the blood) levels. So why did Hydroxycut cause his liver problem? The UCLA physicians who submitted this case study suggest that it may be related to some of the ingredients in the product. This was the third case of liver toxicity linked to Hydroxycut reported in the medical literature. As with this case, the other “victims” also ingested the recommended dose. Three of the ingredients of Hydroxycut, namely Garcinia cambogia, Gymnema sylvestre, and green tea, have all been associated with severe liver toxicity. In one case reported last year, a man used two fat-loss products containing these ingredients (one was Hydroxycut) for only a week, then died of fulminent liver failure. Complicating the case was the fact that he was also ingesting a type of drug called a leukotriene antagonist (used to treat asthma, I take one myself). The theory is that the combination of the drug and the supplement ingredients resulted in rapid liver failure. Green tea extract has been shown to cause liver problems, but it’s difficult to explain why, since the active polypheonols in green tea aren’t absorbed too well, and you would have to ingest far more than is contained in any type of fat-loss supplement. There is the possibility, however, of an idiosyncratic reaction limited to only certain people. The fact that the man was also ingesting Tylenol may have played a role, since the primary ingredient of Tylenol (acetaminophen) is extremely toxic to the liver. Just ingesting 12 tablets at once could alone cause liver failure, and consuming it with alcohol makes it toxic even at lower doses. Since this man admitted a fondness for beer, I suspect that his case of liver failure wasn’t related to the Hydroxycut, but rather to the likelihood that he ingested a large dose of Tylenol with alcohol, which would definitely cause his symptoms. I view this report as alarming, since it reminds me of the previous Ephedrine scare, which was just a conspiracy involving the FDA in collusion with pharmaceutical companies to remove an effective weight-loss product,i.e., ephedrine, that was proven superior in several published studies to existing drugs prescribed to treat obesity. I don’t think the existing medical literature (which I am quite familiar with) justifies pointing an accusatory finger at Hydroxycut or any other existing fat-loss supplement
Studies examining how green tea may be toxic to liver function found the the effect emanates from a parodoxical action of green tea that also exists for other nutrient antioxidants. This involves the fact that large amounts of green tea can act like a pro-oxidant, instead of imparting its usual antioxidant activity. In the liver, the oxidation activity of green tea depletes the primary antioxidant/detoxifyer in the liver, namely glutathione. This suggests that if a person who uses supplements that contain green tea also ingests other nutrients known to increase the liver production of glutathione, such as N-acetylcysteine and milk thistle, the side effects linked to green tea could be blocked.
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The Problem: Liver toxicity following consumption of dietary supplement, Hydroxycut
http://www.fda.gov/oc/opacom/hottopics/hydroxycut/HHE.pdf
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Why not just tell us what they say?
I don't wanna click no pdf
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Why not just tell us what they say?
I don't wanna click no pdf
x2. Im waiting till someone basically summerizes the article in their post.
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i just quickly looked at it. but, 23 cases, 1 dead, most healthily on recommended dose. Some people had their livers go back to the normal range 4-10 months after they stop using it.
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They don't know what caused liver toxicity.
1 person died waitin for liver transplant
1 person had liver transplant
everyone elses was reversed.
Most of the cases were women (I believe)
and reversable.
I hope Jay Cutler is aware of this, did anyone tell him? ;D
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They don't know what caused liver toxicity? Were these people taking anything else that raised their liver levels? Other supplements? Other prescription drugs? If 9 million bottles were sold last year, and three claimed problems, what is the average rate of liver problems in the normal population?
Do they have these studies with over the counter drugs you get at any store too?
The FDA has a lot of people spooked, but with these people, did they conclude that Hydroxycut were to blame only, or did they look at other factors too?
I am sure the FDA and the prescription drug companies would love to regulate and control this lucrative market. They would have already, if it ware not for the DSHEA act a while back.
So how much money did the US buy on prescription drugs in 2008... you will be amazed
IMS Health (NYSE: RX), the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, today reported annual U.S. prescription sales growth of 1.3 percent in 2008, to $291 billion. Dispensed prescription volume in the U.S. grew at a 0.9 percent pace.
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They don't know what caused liver toxicity? Were these people taking anything else that raised their liver levels? Other supplements? Other prescription drugs? If 9 million bottles were sold last year, and three claimed problems, what is the average rate of liver problems in the normal population?
Do they have these studies with over the counter drugs you get at any store too?
The FDA has a lot of people spooked, but with these people, did they conclude that Hydroxycut were to blame only, or did they look at other factors too?
I am sure the FDA and the prescription drug companies would love to regulate and control this lucrative market. They would have already, if it ware not for the DSHEA act a while back.
So how much money did the US buy on prescription drugs in 2008... you will be amazed
IMS Health (NYSE: RX), the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, today reported annual U.S. prescription sales growth of 1.3 percent in 2008, to $291 billion. Dispensed prescription volume in the U.S. grew at a 0.9 percent pace.
qft, this is bullshit i think.
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Omg what is going to happen to Dexter if he can`t take Hydroxycut Hardcore??? No way he can win the O.
HAHAHAHAHAHAHA!
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Good thing your muscle heroes don't take that shit.....
That's just what they need...more liver problems...
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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
Matt, are they pulling Hydroxycut off shelves in Dubai, India, or just here in the U.S.?
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They don't know what caused liver toxicity? Were these people taking anything else that raised their liver levels? Other supplements? Other prescription drugs? If 9 million bottles were sold last year, and three claimed problems, what is the average rate of liver problems in the normal population?
Do they have these studies with over the counter drugs you get at any store too?
The FDA has a lot of people spooked, but with these people, did they conclude that Hydroxycut were to blame only, or did they look at other factors too?
I am sure the FDA and the prescription drug companies would love to regulate and control this lucrative market. They would have already, if it ware not for the DSHEA act a while back.
So how much money did the US buy on prescription drugs in 2008... you will be amazed
IMS Health (NYSE: RX), the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, today reported annual U.S. prescription sales growth of 1.3 percent in 2008, to $291 billion. Dispensed prescription volume in the U.S. grew at a 0.9 percent pace.
Do you think the FDA should leave the supplement market totally unregulated? Do you think this was a completely political move, that they are just lying to try to scare customers of supplements?
Do you think the FDA acted wrong when it warned of the potential sides from Syntrax Lipokinetix?
I don't think Hydroxycut is dangerous for most, don't know if it's dangerous in any healthy person. But I don't think this warning was totally outrageous.
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qft, this is bullshit i think.
I think so too...
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I was looking through an old junk drawer and found that I have an original bottle of hydroxcut with Ephedra, but I only have two pills left. What should I do with it?
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take the blue pill.
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RIP
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no joke here but two years ago i took hydroxycut, and after 15 day of use i've got severe "gall blader" (vesicule biliaire in french)trouble, with a high rate of "bilirubine" in my blood for several month, i was weak and tired, gum bleeding, dizziness also... :'(
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no joke here but two years ago i took hydroxycut, and after 15 day of use i've got severe "gall blader" (vesicule biliaire in french)trouble, with a high rate of "bilirubine" in my blood for several month, i was weak and tired, gum bleeding, dizziness also... :'(
if you went to a doctor, and it was recorded, you're in the $$$ ;D
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During 1999-2004, I used to take 12 Hydroxycut "regular" caps (4/3x per day) which was the recommended max dosage at the time. Honestly, I loved it. At the time, I had my nutrition store & Hydroxycut was by far was the #1 seller. It kind of makes me wonder if this contributed to some of my health issues. I experienced several unexplained seizures which is still a mystery to my docs. Also, add in the constant elevated liver enzymes. ???
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During 1999-2004, I used to take 12 Hydroxycut "regular" caps (4/3x per day) which was the recommended max dosage at the time. Honestly, I loved it. At the time, I had my nutrition store & Hydroxycut was by far was the #1 seller. It kind of makes me wonder if this contributed to some of my health issues. I experienced several unexplained seizures which is still a mystery to my docs. Also, add in the constant elevated liver enzymes. ???
join the class action lawsuit. ;)