FDA Warns Consumers to Stop Using Hydroxycut Products

[volcanicweather]

FDA LINK

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.

Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

Ads for this used to be on TV all the time... now I know why they went away.

[Headspace]

Good thing I use Vaxadril.

[Quixon]

I took the Hydroxcut Hardcire Liquid Capsules for like about 10 days. 1 Pill (1/2 - 1/3 the recommended dosage) was giving me the shakes and headaches after 7-8 days. I stopped using em after that. Good thing I did lol.

[MisterBob]

People actually used these sketchy-ass things? Wow, just wow.

[guartz]

People actually used these sketchy-ass things? Wow, just wow.

I know right? Boggles my mind.

This is coming from a chain-smoker.

[Mizango]

Yeah diet pills are all the rage. Just work out and eat mexican food. The constant purging of your colon will help you drop any and all excess weight.

[Stumblingdrunk]

Aside from gym rats a lot of people in the food service industry use them as well, (servers, bartenders) it's a nice little energy boost.

[Diamicles]

About 1 million bottles of hydroxycut are sold in a year, so yeah people like to use 'em. Same risks run with each of the other similar weight loss products, there's a reason why the FDA won't evaluate them in the first place.

[MisterBob]

The FDA won't evaluate them in the first place due to jurisdictional issues (refer to the case regarding Ephedrine for precedence)

[Not Kuno]

MAJOR UNIVERSITY DOUBLE BLIND STUDIES ARE NEVER WRONG

[Fhqwghads]

Serves people right. People always want a shortcut to weightloss instead of doing it the correct way (aka diet & exercise.)

[Dimmauk]

I wish more people would use the Weight Loss Inhaler.

http://metropolitician.blogs.com/scr...s_image120.jpg

Results dont lie
Before and after
http://cdn-media.channelme.tv/media/...ODEx_large.jpg

[OzzofAsura]

Serves people right. People always want a shortcut to weightloss instead of doing it the correct way (aka diet & exercise.)

This for sure.

[Diamicles]

The FDA won't evaluate them in the first place due to jurisdictional issues (refer to the case regarding Ephedrine for precedence)

Right, that's actually what I was referring to. Loads of unwanted side effects (including death) can occur if you aren't very careful taking these sort of stimulant products.

[tyven]

"diet pills dont kill the liver" - Chase on House s04e16

WRONG

[MisterBob]

Right, that's actually what I was referring to. Loads of unwanted side effects (including death) can occur if you aren't very careful taking these sort of stimulant products.

Uh, are you familiar with the meaning of the word "jurisdictional"?

[Diamicles]

Uh, are you familiar with the meaning of the word "jurisdictional"?

No clue.

I have worked in a pharmaceutical lab for about the last 5 years, so I know a little about what the FDA evaluates, why the use that criteria, and how they enforce their guidelines. While I may not be familiar with litigation that involves these sort of products, I have firsthand experience dealing with the FDA, and the companies that are trying to get their drug products approved through the proper processes. I would be interested to know more specifics on why they do not take any jurisdiction over these kind of products, though.

They will not evaluate the use and dosing of any stimulant weight loss products because there are too many inherent problems that come with taking them, even over the short term. They are fully aware of the dangers that come with taking these products, and the reaction of the product in different people varies too widely for a dependable clinical trial to be put in place. The ephedrine cases were probably handled a little differently due to the 'high profile' deaths of people with that product in their systems.

edit: the FDA does have control and/or regulation over all drug products sold as 'over the counter', all drugs must go through and be approved with a NDA (New Drug Application). They can then be changed to OTC status. Weight loss suppliments are not evaluated by the FDA at all, which it explicitly states on the label.