Hydroxycut® Recalled

The U.S. Food and Drug Administration (FDA) announced the recall of 14 Hydroxycut® supplements due to reports of serious liver damage in patients who took the recommended dosages. Liver damage linked to Hydroxycut® use has resulted in at least one death and one liver transplant.

The recalled products are marketed as weight-loss supplements under the Iovate and MuscleTech brand names.

So far, the FDA has received more than 20 reports of serious health problems ranging from jaundice to liver failure. Symptoms of liver damage may include nausea, vomiting, light-colored stools, fatigue, weakness, abdominal pain, itching and loss of appetite. Other adverse effects that have been reported include seizures; heart problems and rhabdomyolysis, a type of muscle damage that may lead to kidney failure.

The FDA has not determined which ingredients or other factors may be associated with the reported health risks.

 

The recalled products include:

• 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®

 

Hydroxycut Cleanse® and Hoodia® products, two other products marketed under the Iovate or MuscleTech brands, are not affected by the recall.

 

For more information about dietary supplements for weight loss, please visit Natural Standard’s Foods, Herbs & Supplements database.

Comments

[Deb T.]

I read about this on the web in a report that stated the fatality involved a young man who died in 2007, but his death was not reported to the FDA until 2009. Why the time lag?

And given the large number of ingredients in these products, how will it be determined exactly what ingredients are to blame? I wonder if that is up to the company, or does the FDA do that investigation? Enlighten me, please!

[Theodore Thermopolis]

When will people realize that when it comes to physical fitness and well-being, there is no pop-a-pill answer? In fact, there aren't many pop-a-pill answers, and this is coming from a pharmacist-to-be. We always seem to be searching for that short-cut to perfect health, but how many pitfalls have we and will we continue to fall down? It's about time this product gets yanked off the market, it has been causing health issues and concerns for years. Nothing like a bottle full of false hope with the potential to do more harm than good.

[Bobby]

Deb, I think there is a delay in reporting the young man's death because they had to probably go through litigation to prove it was related to Hydroxycut use. I am pretty sure the Hydroxycut company doesn't have to do any real investigation as to which ingredient is to blame, and then it falls on the FDA to investigate what ingredient is the culprit. It is scary that the company doesn’t have to do anything but say, “So our product caused harm to someone and we're sorry, but now you tell us which ingredient did the harm and…” Does anyone else feel this way?

[Nick M]

Hydroxycut contains ingredients that are commonly found in other over-the-counter weight loss supplements, such as green tea, caffeine, chromium, and garcinia cambogia. Even though these ingredients are common and I would not suspect something like caffeine to cause hepatotoxicity, these supplements are not regulated by the FDA and may contain contaminants and which might be a possible cause of the toxicities as well. I wonder if the FDA will be pro-active in recalling other supplements with similar ingredients as Hydroxycut, or if it will wait for more reports to come in. This is yet another example of why the FDA must start regulating these supplements, as they can have some very significant and dangerous health consequences.

[WC]

Will the voluntary recall of Hydroxycut® have an effect on other products with similar ingredients?
This reminds me of the FDA ban of ephedra-containing supplements in April 2004. That ban resulted in the sale of "ephedrine-free" ephedra. Perhaps both Iovate and MuscleTech will re-formulate Hydroxycut to try to bring it back to the market.

[David Goldberg]

Another striking example of the FDA's double standard in action: destroy a natural product containing safe ingredients but unwarranted health claims that MAY have harmed one individual while continue to promote the use of documented deadly, FDA-approved Rx medications. The cash-lined pockets of big pharma continue to grease the wheels of the FDA; pharma aiming the FDA's guns at any natural products producer unwilling to jump through their expensive hoops of drug development.

[linda]

I completely understand the concern and the need to investigate, but i find it rather hypocritical of the FDA to "go the mile" so to speak over this, and yet allow the plethora of pharmaceutical drugs that give you five pages of microprint describing everything that can go wrong to be prescribed.

The FDA as far, as i am concerned (and I am making a generalized statement, as I am sure there are individuals who are very dedicated to the well being of man), has become a lackey of the pharmaceutical industry meant to give legitimacy to the industry.

[Kara]

TT, I agree that there is no magic pill to melt the fat away. We need to continue to encourage good nutrition and exercise from an early age. However, it is frustrating for folks whose weight issues have become overwhelming, and it is embarrassing as well. Of course a magic pill would be wonderful. They just do not exist.

And Nick, the real challenge for regulatory bodies like the FDA is to be able to ban substances that cause problems in a significant amount of people, and that requires studies. I think conscientious supplement makers welcome study and regulation.

[Ajlouny]

Since this is being announced as a "recall," what do consumers need to do to get full refunds from the company if they bought the product?

[Eugene]

There needs to be a switch in the way we regulate OTC medications, especially the herbs/supplements. This article helps raise awareness, but I want to know how old the 14 patients who suffered from liver damage were. If they were the typical college student ages, then maybe the reason for the liver damage wasn’t completely Hydroxycut's fault -- alcohol can lower the toxicity threshold of many drugs. An example of alcohol lowering the toxicity threshold of a drug is acetaminophen; toxicity usually occurs at doses over four grams/day, but if a person has two drinks per day, then the toxicity can be seen at three grams/day.

Most people don’t use Hydroxcut for its intended use for weight control; instead they use it as a stimulant to get through their college finals. I think we should, as a nation, support a regulatory agency that we’ll call the HSA (Herbal & Supplement Administration), and its job would be to start requiring herbs/supplements to conduct clinical studies to show efficacy.

[Mike D]

Kara, I am also curious about the recall procedure now that the recall has been announced. Even though this article states that Hydroxycut from the brand name MuscleTech is being recalled, if you go to the MuscleTech Web site, you can still purchase Hydroxycut! I didn’t actually go through with the order, but there was nothing to indicate that the product had safety concerns associated with it or that it was off the market. The Web site allows users to enter all of their credit card information and everything, which I find to be a little bit appalling and unethical.

[Edward B]

The FDA cannot just order a recall though, it has to be voluntary. So the FDA has asked MuscleTech to withdraw Hydroxycut from the market, and they voluntarily agreed. At that point, MuscleTech is responsible for the recall and must follow-up with the FDA to ensure that the recall is successful. The FDA seems to be telling consumers that they should "get rid of" any Hydroxycut (throw out?) they have. One manufacturer, Iovate, recommends that they return the product to the place of sale. Are health stores that sell Hydroxycut responsible for giving consumers refunds? Shouldn’t the manufacturer be refunding people?

[Vegan Girl]

I feel that we have lost focus of what is really important. We seem to correlate being thin or muscular with being healthy. Being truly healthy has absolutely nothing to do with how you look in the mirror. Proper nutrition, proper exercise regiments and healthy vitamin supplementation should be taught in our schools and healthcare facilities around the country. And I agree, every supplement on the market should be investigated and regulated by the FDA. It wouldn’t hurt for the FDA to show that it actually cared about the health of the American people.

[Nadja Zuton]

I agree with Vegan girl, although I don’t know if FDA regulation of vitamins and supplements is anywhere in our near future due to issues like lack of FDA funding, drug company lobbyists, etc. The Hydroxycut recall is an issue that highlights this lack of management by the FDA, but the issue already seems to have fallen into oblivion and out of the news. Instead of causing heated debates and forcing the FDA to improve upon itself and its practices, these issues just seem to disappear and be forgotten. I am happy that Natural Standard highlights them, as I think that this is a really important issue for the vitamin industry (even if they don’t think so).

[angel]

I would not recommend hydroxycut for someone who wants to try to loose weight. Exercise and diet are the best options for those people who want to loose weight. There are a lot of free exercise programs that people can join. For example, Nike has a running session every Wednesday evening in front of Nike store on Newburry street, which is pretty fun.

[Ken]

This Hydroxycut recall just goes to show that although an agent is natural, it does not mean that it is safe. A few comments above suggested that pharmaceutical drugs are still on the market and yet have many serious side effects. However, all that information on the drug's adverse effects is due to much study, investigation and regulation. When a lot of regulations are made regarding an agent (herb, supplement, or drug), then healthcare providers will be able to make the appropriate recommendations, and patients will be able to take these agents knowing that the benefit outweighs any risks.