FDA recalls Hydroxycut

[Pharm_Fed]

Just found this.

http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html

FOR IMMEDIATE RELEASE
May 1, 2009

Media Inquiries:
Susan Cruzan, 301-796-4540
Consumer Inquiries:
888-INFO-FDA


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.

–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

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

For more information:

Hydroxycut Products
Dietary Supplements -- Overview

FDA 101: Dietary Supplements

NIH Office of Dietary Supplements

 

[h8tr3d]

wow!

 

[MMX2]

You know- it just like the ephedra drinks more than likely- some tool takes 6 pills at a time and then wonders why they get sick.

 

[MrPerfect]

i agree with mmx2, most people dnt drink enough water and assume the more you take the better the results

 

[jtunderdog]

This is the start of something bigger I suspect. It is eventually going to be a recall on any supplement not fda regulated because they will say the potency is not uniform. Its coming.

 

[Pharm_Fed]

This is the start of something bigger I suspect. It is eventually going to be a recall on any supplement not fda regulated because they will say the potency is not uniform. Its coming.

Might as well just get geared up in that case then....FDA regulated will mean less potent and more expensive. Bad for everyone.

 

[dreww]

The thing that they fail to mention is how many people die per year from tylenol ibuprofen, etc, etc...One person who may have died from this product and they pull it?? Seems kind of bizarre IMO.

thats cause the powers that be get a nice cut from those medications

 

[PIMPn8EZ]

That is nuts! You said it dreww... pad someones pocket with cash and that will fix the problem. wtf? Before you know it you wont be able to buy an energy drink at the local store either because of all the young kids that drink 5 of them a day. Health risk my ass... should be an IQ risk!

 

[The Booger]

i agree with mmx2, most people dnt drink enough water and assume the more you take the better the results

It's that way with sooooo many things. "If two is good, I bet four is twice as good!"

I had a friend that did Halodrol, no idea what the hell he was doing. I don't remember the *exact* dosage but he was taking a massive amount. Good thing I had some PCT stuff on hand for him, he was bitching he couldn't get hard like a month or so after.

 

[herpdude]

You know what "bull shit"

 

[Stickler*]

like anything else... NOT FDA approved...we all do it anyway.... untill it's a 'class action loss suite' .. period... so the bottom line is... do what you take at your own risk... and like anything here.. be ready for the results of your actions..

if you're here.. then you are over 18 an completely responsible for your own actions... ya know what? .. we take shit here that are 'supplements' .. and ya ... know what... ? ... we do shit regardless of whatever anyone else says anyway.. that's why we post here... so do us all a favor... take whatever it is you're gonna take, and document everything. So, with that... take what you take, post it here, help us all.. if and 'God forbid,' something else happens... then let us know.. so we can be apart of what needs to be 'taken apart-of' .. lol ... if that makes sense...

 

[dorian123]

all about the dollar:thumbsup:

 

[herpdude]

all about the dollar:thumbsup:

agreed:curse:

 

[jtunderdog]

I had to laugh when I told my mother in law about this. She was so worried about her hydroxycut body purge or some crap. She smokes 3 packs a day, has 300 cholesterol, and drinks like crazy. Oh yeah the body cleanse is the answer. LOL I told her she would be better off if they illegalized marlboros.

 

[saturn1]

what I found incredible is that hydroxycut is 90% of the fatburning market........thats HUGE!

 

[jshoty]

what I found incredible is that hydroxycut is 90% of the fatburning market........thats HUGE!

Yup, i used to make 2 dollars a bottle on these when i managed GNC store... Here ya go fatty take this, and watch the weight melt off!

 

[SHOTGUN]

Safer than Multi's?

21 cases out of 54 Million + bottles? Thats better than Multivitamins isn't it? I wonder how many were chicks trying to drop 30 pounds in 10 days for their wedding or vacation?

 

[saturn1]

I assume we will see more of this as more and more pharm companies are purchasing supp companies .....They already own EAS and other popular brands....abbot labs will make a case that they do it better and that supps should be controlled by them.

But these things always happen and usually at the fault of the user doing extreme things to get results......Just like the people who abused ephedrine.

 

[Get_Swole]

how retarded a local idiot not too long ago came home after a night of heavy drinking and took like 12 tylenol to avoid a headache the next morning and woke up with jaundice and was in the hospital for a long time. Dont think his liver will ever be the same. You will never see them take tylenol off the shelf though will ya.

 

[saudades]

^ ^ ^ Exactly!!