Hydroxycut recall

rusty_blackhaw(6a)May 2, 2009

A popular line of supplements marketed as diet aids, "fat burners" and energy enhancers has been pulled after reports of severe injuries associated with the products.

"The 23 reports of adverse effects include liver damage, elevated liver enzymes (which indicates potential liver damage) and liver damage requiring a transplant. A 19-year-old man died after using Hydroxycut. "The death occurred in 2007," Katz says, "and was reported to the agency at the end of March 2009."

"Hydroxycut products contain a variety of ingredients and herbal extracts," Katz said. The FDA has not yet determined which ingredients or doses are associated with the liver problems, according to Katz.

Other reported health problems include cardiovascular problems, seizures, and serious muscle damage (rhabdomyolysis) that can cause kidney failure."

"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...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."

More here and here.

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gringojay

As seen on TV; always wondered if it even did anything - now know side effects.
? What is the ingredient list ?

    Bookmark   May 2, 2009 at 6:21PM
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rusty_blackhaw(6a)

Here's a listing of ingredients for one company product.

According to the story I read in our local paper, Hydroxycut has changed formulations numerous times, making it harder for investigators to determine what component(s) are associated with liver damage and other side effects. The hydroxycitric acid believed to be hepatotoxic is not listed in the above link.

Oddly, when you do a Google search on "Hydroxycut ingredients", a number of Hydroxycut links pop up - but they all seem to have been switched to the same company announcement about the recall.

Damage control?

    Bookmark   May 2, 2009 at 11:48PM
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apollog

Personally, I'm not a fan of miracle weight loss products. But by the "evidence-based medicine" standards that eric demands of everything, we cannot make any definitive statements about Hydroxycut. Without multiple double-blind, placebo controlled studies that document that Hydroxycut causes liver damage, this is merely speculation on the part of the FDA.

Liver enzymes are sometimes elevated in normal people for no apparent reason, and a high reading is not proof of any type of damage ... "Elevated liver enzymes may be detected during liver function tests. In most cases, liver enzyme levels are elevated mildly and temporarily. Most of the time, elevated liver enzymes don't signal a chronic, serious liver problem." (source)

How many of these 23 cases were truly serious? How many are unrelated to the supplement? We know that if millions of people were taking some placebo (something that doesn't cause liver disease), some people in that group would develop liver disease just by chance each year ... a placebo controlled trial would allow us to filter out the natural rate of liver disease. But we don't have such a study - only a group of correlational observations that is somewhat interesting and may merit further study in the future.

...In all seriousness, if someone I knew were taking that product, I would advise them to stop until more is known. The above post was intended to point out the limits of the so called "evidence-based" approach that eric uses to smash discussion of herbs (and which he conveniently abandoned in this post when he saw a chance to further scare people about supplements). At this point, we don't really know if there is a risk (according to eric's terminology, we should say that concerns regarding the product are currently 'unproven') ... but EBM is not a universal methodology that is applicable to every situation ... my operating assumption is that we don't always need 100% certainty to make a reasonable decision; in this case I think caution is in order.

    Bookmark   May 7, 2009 at 6:05PM
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rusty_blackhaw(6a)

Your points are addressed in the separate thread you found it necessary to start on this subject.

    Bookmark   May 7, 2009 at 6:47PM
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