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FDA Warns Consumers to Stop Using Hydroxycut Products

Z

Zoknat

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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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MrChewiebitums

MrChewiebitums

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FDA > Fuckin dickhead agency

recall for cigarettes.... were is that?
FMA> Federal money agency thats wat it should be called
 
Tech

Tech

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seems kinda pointless.
 
Limpboy

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What is Dexter going to use now to get rip:bitenails:
 
D

DriDDeRz

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watch now how many people are going to go on a spending faze and buy heaps of it now
 
R

Ruhlforever

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Katz Katz Katz ummmmmmmmmm... sounds familiar
 
Duality

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was at work the other day and was shocked to hear this. we know have a massive collection of all kinds of hydroxycut just sitting on our backshelves. this is going to be a large financial hit for MT. and really, pretty fucking stupid. like chewie said, where's the recall for cigarettes? alcohol? those seem to do some damage to a number of organs. but hydroxycut.......no no we can't risk allowing such a plague on the people
 
Adam23

Adam23

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liver damage ?? i think that happen because people overdose on the the Supplements, they think more is better :no:

the problem is not with the Supplements, its with the people.
 
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MuscleMecca Crew

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H

Hane

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It have always been like that and there will always be like that. People who dont know the product seem to overdose etc and when they face the consequence they'll blaim the product.

Aka. Stupidity :p
 
The Creator

The Creator

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Talking with my buddies over at bb.com, they say that things have been crazy busy with this recall. Something along the lines of the yohimbine in the supplement was methylated much like the methylated PH's and that is what was causing the liver damage because many people take this year round as an energy supplement. bb.com is refunding everyone and then muscletech will have a nice check to write to reimburse them!
 
sexnews

sexnews

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The following statement was issued today by Iovate regarding the Hydroxycut recall.

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
 
sexnews

sexnews

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The Truth About Fat Burners And Hydroxycut
Tom Venuto

The United States Food And Drug Administration (FDA) has warned dieters and bodybuilders to “immediately” stop taking the weight loss diet pill Hydroxycut, citing 23 reports linking the supplement to liver damage and the death of a teenager…

Hydroxycut is a heavily advertised herbal weight loss diet pill with reported sales of 1 million bottles per year. Stories of the diet pill recall have begun hitting all the major newswires, including Reuters, CBS News, The New York Times, CNN and The Associated Press

Official FDA Press Release
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

The story is also one of the top trending topics on Twitter, the micro-blogging website where news often breaks and spreads quickly.

Generally, a single case study or adverse effect report is not a cause for alarm. Often case studies of adverse effects from use of herbs or supplements are merely rare anomolies in susceptible individuals where use of the ingredients were contraindicated, other products/ingredients/drugs were stacked, and or the products were taken at abuse dosages. When millions of people take a product, someone is bound to have a reaction of some kind.

In fact, you even occasionally see a negative adverse effect report for supplements such as creatine, which now has an experimental research-proven track record of safety.

Experimental research is needed to determine both efficacy and safety. However, “herbal” or “natural” does not necessarily mean safe and the supplement industry is highly unregulated. Adverse effects from the use of so-called “safe” and “natural” herbal supplements have appeared in the research data bases for years the recent Hydroxycut recall is only one example.

So far, health officials don’t know which ingredient in Hydroxycut was causing the problems because it contains numerous ingredients and the formula has changed more than once. Researcher Ano Lobb says the problem may be hydroxycitric acid.

Hepatoxicity associated with weight-loss supplements: a case for better post-marketing surveillance (April 2009)
http://www.ncbi.nlm.nih.gov/pubmed/19360927

Severe hepatoxicity due to Hydroxycut: a case report
http://www.ncbi.nlm.nih.gov/pubmed/18661239 (Feb 2009)

Hydroxycut hepatotoxicity: a case series and review of liver toxicity from herbal weight loss supplements (Dec 2008)
http://www.ncbi.nlm.nih.gov/pubmed/19058338

Acute liver injury associated with the herbal supplement hydroxycut in a soldier deployed to Iraq
http://www.ncbi.nlm.nih.gov/pubmed/17897352 (2007)

Two patients with acute liver injury associated with the use of the herbal weight loss supplement Hydroxycut (2005)
http://www.ncbi.nlm.nih.gov/pubmed/15767636

Over the counter herbal supplements are not necessarily free of side effects or risks. Like drugs, supplements should be viewed in terms of their risks versus benefits. After weighing the evidence, even if the risk is low, are the benefits high enough to justify the use of these products? What I’m asking is, do they even work? And if so, do they work well enough to justify the expense or do the benefits amount to minutia?

When you look at how ineffective over the counter herbal fat burners really are (based on research data), I always ask myself, why bother? Why waste the money? And with the way most of the advertising overstates the claims or distorts the research, why give your money to those companies?

I am a lifetime natural bodybuilder. I have never use banned or illegal drugs to enhance my physique or performance. I did use ephedra/caffeine products in the mid to late 1990’s - which was legal and available over the counter. However, I found them only marginally helpful. They were highly overrated as fat burners and underrated as stimulants, in my opinion.

Since then I have been able to achieve low single digit body fat, and contest-ready condition without the use of any fat burners of any kind. They don’t make much difference.

Those great bodies you see in the advertisements don’t come from a fat burner supplement
 
Cork

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Serving size is like 27 pills, chased with vodka right?

I've personally never taken Hydroxycut, but this doesn't bode well for the industry if this was recalled. It just leads me to ask 'What's next?'
 
Hypocrisy86

Hypocrisy86

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Some of those muslcetech supps are ridiculous anyway, or most i mean. like gakic and those other pill forms, and of course the Cell-tech, 8caps 3+ times a day...4+ scoops etc etc, then you'll get someone thinking 2 more wont hurt per servings, or hmm how bout' an extra scoop..
 
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