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Smiling Assassin27
05-01-2009, 11:18 AM
Normally, I'd stick this in the weight loss thread, but it may not get proper exposure.

FDA announces recall of popular diet pill
Hydroxycut linked to reports of liver damage, other health problems
BREAKING NEWS
The Associated Press
updated 11:00 a.m. MT, Fri., May 1, 2009
WASHINGTON - 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.

Other patients experienced symptoms ranging from jaundice, or yellowing of the skin, to liver failure. One received a transplant and another was placed on a list to await a new liver.

There was no immediate comment from the U.S. distributor of the diet pill, Iovate Health Sciences, headquartered near Buffalo, New York. Hydroxycut is used by people trying to shed pounds and by body builders to sharpen their muscles.

Dietary supplements aren't as tightly regulated by the government as medications. Manufacturers don't need to prove to the FDA that their products are safe and effective before they can sell them to consumers. But regulators monitor aftermarket reports for signs of trouble, and in recent years companies have been put under stricter requirements to alert the FDA when they learn of problems.

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.

The FDA relies on voluntary reports to detect such problems, and many cases are never reported, officials acknowledge.

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.




2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

LonghornBronco
05-01-2009, 11:29 AM
I did not realize the FDA does not review diet "pills"...

DenverBroncosJM
05-01-2009, 11:34 AM
Better off just going on a EC stack fi you want to lose some pounds. I know that ephedra is "banned" but its still available and the "side effects" are nothing compared to the other diet pills.

maher_tyler
05-01-2009, 02:41 PM
You wanna know how to lose weight...exercise at least 3 times a week and a healthy diet!! Don't eat anything around 3 hours before you go to bed. Thats how you lose weight in a nut shell!!

Hogan11
05-01-2009, 02:45 PM
Better off just going on a EC stack fi you want to lose some pounds. I know that ephedra is "banned" but its still available and the "side effects" are nothing compared to the other diet pills.

Ephedra was great stuff, but unfortunately some people cannot follow directions printed on a bottle, which causes them trouble (in this case, death) and then the kneejerk reactions follow suit (banned). I tried Hydroxycut a couple of years ago and it didn't work for me. Dexatrim is the only stuff I've taken since the banning of ephedra that I can honestly say worked when combined with a decent diet and exercise.

Kaylore
05-01-2009, 02:56 PM
"It really works fast"

/Blinks with soul-dead look in the eyes.

gyldenlove
05-01-2009, 03:20 PM
I did not realize the FDA does not review diet "pills"...

Anything classified as a supplement is not FDA reviewed unless there are reports and cases where it is confirmed to have caused serious harm.

You are better off downing a few painkillers every morning than taking a lot of the supplements out there, with a pain killer you know to the nanogram what you are getting, with a supplement it is anyones guess and may vary from package to package.

tnedator
05-01-2009, 03:20 PM
I did not realize the FDA does not review diet "pills"...

The FDA doesn't review/approve any dietary supplments. Until this year, they also did no inspections of supplement manufacturing facilities, unless there was a problem of some kind.

Starting this year (inspections to begin this fall), they will start enforcing GMP (good manufacturing principles) that includes procedures to 'prove' or validate that what is claimed to be on the label is in the product.

It is a highly unregulated industry.

Chris
05-01-2009, 03:36 PM
They should have to test and approve all of them. It's ridiculous and unsafe. It would never fly in Europe. That movie "Bigger, Faster, Stronger" tried to make the point that this was allowed because the manufacturers made big campaign donations to the people in power, particularly Utah Senator Orrin Hatch who created a bill in the early 90s effectively making this law.

tnedator
05-01-2009, 03:42 PM
They should have to test and approve all of them. It's ridiculous and unsafe. It would never fly in Europe. That movie "Bigger, Faster, Stronger" tried to make the point that this was allowed because the manufacturers made big campaign donations to the people in power, particularly Utah Senator Orrin Hatch who created a bill in the early 90s effectively making this law.

They don't test and approve supplements in Europe either. Even in countries that have stricter regulations, it is purely based on 'what is printed on the label' not testing to confirm what is on the label is in the bottle. Again, like in the US, that changes when there is concern of a contamination or other problem, but nothing beyond that.

Deuce
05-01-2009, 04:21 PM
The FDA is a joke and probably harms way more people than it helps. The supplement industry, as unregulated as it is, is an overwhelmingly safe industry. As soon as the FDA gets it's hands on it, the only people that will be hurt will be the consumer. Let people decide for themselves what they want to put in their body.

maher_tyler
05-01-2009, 04:46 PM
Ephedra was great stuff, but unfortunately some people cannot follow directions printed on a bottle, which causes them trouble (in this case, death) and then the kneejerk reactions follow suit (banned). I tried Hydroxycut a couple of years ago and it didn't work for me. Dexatrim is the only stuff I've taken since the banning of ephedra that I can honestly say worked when combined with a decent diet and exercise.

Hmmmmmmmmmmmm...Hilarious!

tnedator
05-01-2009, 05:04 PM
The FDA is a joke and probably harms way more people than it helps. The supplement industry, as unregulated as it is, is an overwhelmingly safe industry. As soon as the FDA gets it's hands on it, the only people that will be hurt will be the consumer. Let people decide for themselves what they want to put in their body.

Actually, it's all over the board. It might not be an 'unsafe' industry, although there certainly have been cases of that, but it is also an industry where you can't assume what is on the label is in the bottle. There are a lot of 'garage manufacturers' out there.

Having said that, like with most things the government does, the GMP's the FDA has implemented are ridiculous.

By their own estimate, 50% or more of supplement manufacturers will go out of business, since they will have no way to meet the over the top regulations.

Hogan11
05-01-2009, 05:15 PM
Hmmmmmmmmmmmm...Hilarious!

Sometimes an appatite surpressant is necessary to achieve your goal, especially if you plateau.

Chris
05-01-2009, 05:21 PM
Part of the problem is americans tend to be extreme. We all set extremely high goals, often based on aesethetics put forth in the media. Ultimately the most important thing is good health but so many of these supplements do more to jeopardize than promote that.

CHANGSTER
05-01-2009, 05:36 PM
I just told a friend who's pretty much dependent to this stuff that it got recalled. Dude already lost a ton of weight and he was just using it because he had no energy without it. Strange side affect, we'd be standing around and the idiot would just throw up out of nowhere. Only guy I know who throws up before he starts drinking. Anyways, I told him to quit the junk and to stop being a moron.

Deuce
05-01-2009, 05:54 PM
Actually, it's all over the board. It might not be an 'unsafe' industry, although there certainly have been cases of that, but it is also an industry where you can't assume what is on the label is in the bottle. There are a lot of 'garage manufacturers' out there.

Having said that, like with most things the government does, the GMP's the FDA has implemented are ridiculous.

By their own estimate, 50% or more of supplement manufacturers will go out of business, since they will have no way to meet the over the top regulations.

You hear about "FDA approved" drugs killing people all the time, that have to be taken off the shelves. So you have the FDA slowing progress and hurting consumers and they still approve drugs that are unsafe. The point is, you are never going to be 100% safe 100% of the time. So you have to ask yourself if the regulations are causing problems that are actually worse than the problems they are trying to solve.

The FDA is inherently anti consumer. The nature of the situation dictates that be overly cautious, at the expense of the patient. If they approve a drug that is harmful, everybody will soon know about it and point to the FDA. But if they simply don't approve a drug, even if the possibility of somebody being harmed is extremely slim and the benefits are potentially huge, nobody will know because it never gets released. So they release very few drugs and only the very safest ones. And yet harmful ones are still released. It's pointless. It takes the power away from the patient and doctor (where it belongs) and puts it in the hands of a bureaucrat in Washington whose only interest is his own.

tnedator
05-01-2009, 06:28 PM
On a completely unrelated subject, but ironic. The new NFLPA rep, D. Smith is a partner at one of the largest/best firms that represents companies in dealings with the FDA. Just ironic in that we are on a football forum talking about the FDA.

maher_tyler
05-01-2009, 06:34 PM
Sometimes an appatite surpressant is necessary to achieve your goal, especially if you plateau.

Thats basically all they put in the stuff...they try to make you think you can lose 50-100lbs just by taking these supplements and its not true!!

Jason in LA
05-01-2009, 06:35 PM
Ephedra was great stuff, but unfortunately some people cannot follow directions printed on a bottle, which causes them trouble (in this case, death) and then the kneejerk reactions follow suit (banned). I tried Hydroxycut a couple of years ago and it didn't work for me. Dexatrim is the only stuff I've taken since the banning of ephedra that I can honestly say worked when combined with a decent diet and exercise.

Pretty much true. Folks that followed the instructions were fine. It was the people popping 3 to 4 pills and then working out like crazy that screwed it all up.

Florida_Bronco
05-01-2009, 07:27 PM
You wanna know how to lose weight...exercise at least 3 times a week and a healthy diet!! Don't eat anything around 3 hours before you go to bed. Thats how you lose weight in a nut shell!!

It's not quite that simple.

Ephedra was great stuff, but unfortunately some people cannot follow directions printed on a bottle, which causes them trouble (in this case, death) and then the kneejerk reactions follow suit (banned). I tried Hydroxycut a couple of years ago and it didn't work for me. Dexatrim is the only stuff I've taken since the banning of ephedra that I can honestly say worked when combined with a decent diet and exercise.

+1. I loved Ephedra.

maher_tyler
05-01-2009, 07:45 PM
It's not quite that simple.



+1. I loved Ephedra.

If your serious about losing weight it is. Your not gonna lose more than 10lbs by just taking a pill. If you ever read the directions it tells you to drink a glass of water with it before you eat...hmmmm wonder why...if you drink water before you eat your stomach is more full..they trick you into thinking your losing weight because of the stupid pill. If you lost weight by taking pills and it had been proven the FDA would approve it!!

Florida_Bronco
05-01-2009, 07:52 PM
If your serious about losing weight it is. Your not gonna lose more than 10lbs by just taking a pill. If you ever read the directions it tells you to drink a glass of water with it before you eat...hmmmm wonder why...if you drink water before you eat your stomach is more full..they trick you into thinking your losing weight because of the stupid pill. If you lost weight by taking pills and it had been proven the FDA would approve it!!

Sorry man, it just don't work like that. Lots of people try that 3 days of exercise and "healthy" diet and get no where, mainly because they aren't doing the right exercises and/or the diet is not conducive to losing weight. Trust me, I struggled with this same problem after I suffered injuries in high school football and then again when I had the staph infections in 2007.

I never could lose weight with ease until I met a few people who had been in even worse situations. They had been on a modified version of the low carb diet, and since I've gone on that and supplemented it with lots of weight training, I've lost weight again with ease.

As far as Ephedra goes, it's thermogenic properties have been well known for decades and it IS a proven supplement for losing weight. An ECA stack is very effective at increasing metabolism, increasing energy and surpressing appetite.

maher_tyler
05-01-2009, 08:13 PM
Sorry man, it just don't work like that. Lots of people try that 3 days of exercise and "healthy" diet and get no where, mainly because they aren't doing the right exercises and/or the diet is not conducive to losing weight. Trust me, I struggled with this same problem after I suffered injuries in high school football and then again when I had the staph infections in 2007.

I never could lose weight with ease until I met a few people who had been in even worse situations. They had been on a modified version of the low carb diet, and since I've gone on that and supplemented it with lots of weight training, I've lost weight again with ease.

As far as Ephedra goes, it's thermogenic properties have been well known for decades and it IS a proven supplement for losing weight. An ECA stack is very effective at increasing metabolism, increasing energy and surpressing appetite.

Yea but what are the side effects...i bet high blood presure is one of them. Your not gonna lose a lot of weight if your not eatting correct serving sizes..thats where a lot of people get lost. They're fallowing they're diet, eatting salads etc. but have a heaping plate with all sorts of dressing and what not all over it. I also think people get impatient and expect immeadiate results..it takes a lot of time to lose weight. Also, breakfast should be the biggest meal and all other meals should progressively get smaller. It's definitely a lot of work!!

Florida_Bronco
05-01-2009, 09:04 PM
Yea but what are the side effects...i bet high blood presure is one of them. The rise in blood pressure is very slight and only temporary. Ephedra opens up airways but constricts blood vessels a small amount. I tested my BP a few times when taking it and saw almost no increase.

Ephedra is safe, provided you follow the rules when taking it.

Your not gonna lose a lot of weight if your not eatting correct serving sizes..thats where a lot of people get lost. They're fallowing they're diet, eatting salads etc. but have a heaping plate with all sorts of dressing and what not all over it. While that's all true, weight loss is a combination of many factors, and making just one misstep can throw off the whole process.

I also think people get impatient and expect immediate results..it takes a lot of time to lose weight. The diet I'm on helped a friend of mine lose 100lbs of body fat in under a year.

Also, breakfast should be the biggest meal and all other meals should progressively get smaller. It's definitely a lot of work!! Breakfast is an important meal, but I don't make it any larger than the rest of my meals.

TheDave
05-01-2009, 09:27 PM
I'm guessing this product has been around for about 15-20 years (I remember seeing ads back in the early ninties)... During that time they have probably had sales north of $1 billion.

But it's pulled off of the market because of 23 "Reports" and 1 death in 2007.

There has to be more to this...

EDIT:

OK According to this site

At least 9 million packages were sold last year, the FDA said.
http://www.google.com/hostednews/ap/article/ALeqM5ijbVgN_ATciR3vPd7y0t41vtzKLgD97TMI4O5


So, since 2007 (when the kid died) they have sold about 23 million packages (2.3 years).

So...

23/23,000,000 = .0001% of the people using this product risk developing liver problems.

There has to be more to this... I'm pretty sure the chance of dying from asprin is greater than that.

DB-Freak
05-02-2009, 05:58 AM
The problem is supplement like these is that you'll always need to take it and eventually develop a tolerance for it.

crazyhorse
05-02-2009, 06:25 AM
It looks like they cant really even tie it to the product. They say, they dont know what ingredient causes it, and that there is an ingredient that potentially causes it.

I'm all for getting it off the market of it's dangerous. But take too many asprins and you will have serious health issues. It's about being responsible in most cases.

This looks like another opprtunity fot the FDA to remove another competitor for the pharmiceutical companies. But I admit, I dont know all the facts.

tnedator
05-02-2009, 01:57 PM
I'm guessing there have been far more livers destroyed by Tylenol.

Finger Roll
05-02-2009, 02:17 PM
I've been taking many supplements for years and haven't had any side effects. I took ephedra, I still take cellmass, Animal pak, 17hd, viraloid ZMA and Protein shakes. I do it because I compete in power lifting and the viraloid is great for sex.

Hogan11
05-02-2009, 02:24 PM
I'm guessing there have been far more livers destroyed by Tylenol.

Acetaminophen is far more dangerous and damaging that any supplement out there I'm willing to bet.

DenverBroncosJM
05-04-2009, 10:34 AM
The problem is supplement like these is that you'll always need to take it and eventually develop a tolerance for it.

You are supposed to cycle it just for that reason. Granted a lot of people do not do it, but it is a good idea.

kappys
05-04-2009, 10:52 AM
I'm guessing this product has been around for about 15-20 years (I remember seeing ads back in the early ninties)... During that time they have probably had sales north of $1 billion.

But it's pulled off of the market because of 23 "Reports" and 1 death in 2007.

There has to be more to this...

EDIT:

OK According to this site



So, since 2007 (when the kid died) they have sold about 23 million packages (2.3 years).

So...

23/23,000,000 = .0001% of the people using this product risk developing liver problems.

There has to be more to this... I'm pretty sure the chance of dying from asprin is greater than that.


You're math probably isn't right there as I'd bet many of those packages were sold to repeat customers.

That said - what margin of safety do you want? Vioxx only slightly increases the risk of heart disease - and now it pretty clear that ibuprofen does as well. That one was pulled, plenty of lawsuits, etc, etc.

One of the questions that arises is it toxic at normal dosages? Tylenol is extremely toxic to the liver but only in overdose. Aspirin is quite safe in apporpriate doses(some risk of increased bleeding) - but give it to a child and you risk Reye's syndrome(liver injury) even at normal doses.