FDA warns consumers to stop using Hydroxycut dietary supplements

Consumers using Hydroxycut products should immediately stop taking the dietary supplements, the Food and Drug Administration warned today after receiving reports of serious health problems related to the drugs.

The dietary supplements -- made by Iovate Health Sciences Inc. of Oakville in Ontario, Canada, and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. -- have been linked to one death and are associated with several serious liver injuries, the FDA said. Iovate has agreed to recall the products from the market.

The FDA has received 23 reports of serious health problems including jaundice, elevated liver enzymes and liver damage requiring liver transplant. Other health problems reported included seizures, cardiovascular disorders and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

One death due to liver failure has been reported to the agency.

Liver injury was reported by patients taking the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice and brown urine, the FDA said. 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," said Linda Katz, interim chief medical officer of the FDA's Center for Food Safety and Applied Nutrition. "Adverse events are rare, but exist. Consumers should consult a physician or other healthcare professional if they are experiencing symptoms possibly associated with these products." 
 
Hydroxycut products are dietary supplements that are marketed for weight loss as fat burners, energy enhancers, low-carb diet aids and water loss. The list of products being recalled by Iovate 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 hasn't 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. (Some hoodia sellers on Monday were sued by the Federal Trade Commission on charges of deceptive advertising for claiming that their produce would help people lose weight.)

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 products contain a variety of ingredients and herbal extracts.

Healthcare professionals and consumers are encouraged to report serious side effects or product quality problems to the FDA's MedWatch Adverse Event Reporting program:

-- Online:  www.fda.gov/MedWatch/report.htm
-- Regular mail: Use FDA postage-paid Form 3500 found at www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
-- Fax:( 800) FDA-0178
-- Phone: (800) FDA-1088

-- Andrea Chang

Photo: The FDA has linked the use of Hydroxycut products to serious health problems. Credit: www.bodyshapersfitness.com

Comments

[CG]

This recall needs to be expanded immediately. Lovate Health also produces Xendarine, which is almost the identical formula to Hydroxycut. I work at a large chain supplement store so I know this is a fact. Also the product "Arson"which is this same formula, and is produced under the brand name Muscle Asylum Project. Anyone taking those products need to be warned they should discontinue their use as these are also the same product as the ones being recalled. LOVATE, DO NOT HIDE BEHIND ONE BRAND, "HYDROXYCUT", EXPAND YOUR RECALL TO YOUR OTHER IDENTICAL PRODUCTS NOW!

[Mc Brandon]

Big surprise. I'm embarrassed that we live in a country where things boob enlargement pills and weight loss remedies that are often not effective or dangerous can be marketed this way. The people who manufacture hydroxycut are greedy evil people who don't give a damn that anybody dies as long as they get rich.

[Former Developer]

It's about time these clowns got shut down

Development at Iovate was about how to make a product that could be commercially exploited. Their legal department was bigger than their Product Development dept--- speaking from direct experience.

Nothing in finished product form is tested on humans. They have sketchy data to support efficacy (not the same as safety), usually by running many trials in parallel and using the one that supported their claim, and dismissing the rest.

Here's a cut-and-paste about the chief formulator, the owner, from an article in the National Post:
(snip)

Mr. Gardiner parlayed a high school education and interest in body-building into
a company that grossed as much as $350-million a year and made him countless
millions personally.

striking evidence has emerged of Muscletech's paucity of scientific know-how, massaging of its own unflattering research data on Hydroxycut and iffy marketing techniques.
The latter included an early magazine spread in which a buff Mr. Gardiner passed himself off as an independent participant in a study
(snip)
Link to the story: http://preview.tinyurl.com/c4tfrx

Sad and sick.

And MuscleTech was one of the better in an industry fuelled mostly by steroid money launderers.

[Thomas McKnight]

Interesting tact here. So attack the owner because he takes a high school education and makes something of himself? I agree he may have had a social obligation to ensure his products were safe. However, in the end he just demonstrated simple marketing – there was a demand and he gave them a product. So is this really about the company or about America and our total look for a simple fix? A pill that makes you thin, an investment that makes you rich and cologne that makes everyone want you. This is more of a reflection of give me what I want and not work for it attitude America has taken as a whole. Sorry I do not believe that anyone posted here as any inside knowledge.

[Sal Kenner]

McKnight, you have really screwed-up values if you call selling an under-tested product that turns out to be dangerous and potentially deadly "Making something of himself." Worse still, you essentially blame the victims for taking the product. Apparently in your mind, wealth equals moral righteousness and victims are to blame rather than the victimizer because their moral failure of indulging themselves in their weakness forced Gardiner to take advantage of them. Sheesh. Deliver me from Ayn Rand fans.

[Tino Thomson]

Tylenol is highly toxic to liver and every year there are many people die from manipulating this drug. Many antibiotics are toxic to our hearing system and liver, but they are allowed to use in many cases. We need to know more details how that 19 years old person died or others have liver damaged from using this product. We should not just go with the flow anymore. Of course, Hydroxycut outrage is happening now, but we need to learn what is going on in details.

[Former Developer]

It's not about his education, it's about Paul Gardiner's total ignorance of the the risks of putting enough stuff in a botttle to kill people.
Thomas, watch for the marketing department to start filling blogs first thing Monday AM with 100s of posts like this: "I have used the products for years and found them to be safe and effective".

Paul and his legal team would take weeks to get legal boilerplate that seemed like it was saying a lot, but really claimed nothing. Check the recent ads...

[Former Developer]

But you are right, anyone who calls it Lovate surely has no inside knowledge. It's Iovate.

See the history of lawsuits. Google "Paul Gardiner" and hydroxycut. Ugly.

[Former Developer]

Tino,

Tylenol is not highly toxic. Cyanide is highly toxic.

There are no perfect medications, but your response has a very mercola.com feel to it. I take antibiotics to ward off opportunistic infections that my medical doctor (and I) deem more hazardous at the time than the side effects. These products cost billions to obtain regulatory approval. Natural supplements cost NOTHING for approval, which is why the natural supp industry exists... any halfwit with a package and a specious marketing claim (improves your vertical jump!!! removes spackle from your colon!!!! and it's a dessert topping!!!!!) can run until shut down.

I used to believe caveat emptor, but too much TV, street drugs and liberal arts degrees make people believe in fact-free science, like naturopathy.

I hope Iovate's management looks good in orange jumpsuits.

Is there a supp that makes inmates pick up trash faster?