FDA Issues Hydroxycut Recall Warning

The U.S. Food and Drug Administration (FDA) 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.

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.

Serious Health Risks

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.
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.
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.
FDA urges consumers to stop using Hydroxycut products in order to avoid any undue risk, says Linda Katz, M.D., interim chief medical officer of FDA’s Center for Food Safety and Applied Nutrition. “Adverse events are rare, but exist,” Katz says. “Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products.

Recalled Products

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 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 these products 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 FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

Online: Medwatch Reporting
Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 800-FDA-0178
Phone: 800-FDA-1088
FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects

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Potts Sadaka LLC is filing lawsuits for victims of Hydroxycut Recall

Our Hydroxycut recall liver injury lawyers are investigating cases of liver failure associated with Hydroxycut.  We are also investigating cases of muscle pain, seizures and heart attack.

On Friday, May 1, 2009, the U.S. Food and Drug Administration (FDA) released an announcement of a massive Hydroxycut recall. According to the advisory, the FDA has received 23 reports over more than seven years about consumers having experienced Hydroxycut liver failure and toxicity coinciding with the time they were taking Hydroxycut-branded products. The advisory states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.”

What is Hydroxycut?

The recalled 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. Advertised as made from natural ingredients, because Hydroxycut is a dietary supplement, its manufacturers are not required to seek FDA approval.

Hydroxycut is the brand name of a top-selling weight loss products which are taken by millions of consumers each year. Hydroxycut products are made by Iovate Health Sciences, which has over 750 items sold in more than 70 countries around the world.  Currently, Hydroxycut accounts for almost 90 percent of the market for weight loss supplements, selling around 1 million bottles a year. Accordingly, there is the potential for a larger number of Hydroxycut lawsuits alleging Hydroxycut liver damage.

The recalled Hydroxycut products manufactured by lovate Health Sciences Inc., of Oakville, Ontario. Hydroxcut is distributed in the United States by lovate Health Sciences USA Inc. of Blasdell, N.Y.

Hydroxycut Recall

The recalled Hydroxycut products contain a variety of ingredients and herbal extracts. Although the FDA has not yet determined which ingredients, dosages, or other factors may be responsible for the health risks, the Hydroxycut products currently being recalled by lovate are:

* Hydroxycut Regular Rapid Release Caplets

* Hydroxycut Caffeine-Free Rapid Release Caplets

* Hydroxycut Hardcore Liquid Capsules

* Hydroxycut Max Liquid Capsules

* 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 Side Effects

As of April 2009, the FDA has received 23 reports of serious health issues and Hydroxycut side effects, including jaundice, elevated liver enzymes and Hydroxycut liver damage. One Hydroxycut death stemming from Hydroxycut liver failure has been reported to the FDA.

Symptoms of Hydroxycut liver damage include jaundice, brown urine, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching and loss of appetite.

Additionally, the FDA has also received reports of other Hydroxycut side effects:  seizures, stroke, heart attack, and rhabdomyolysis (muscle disorder).

Legal Help for Victims of Hydroxycut associated Liver Damage

The Hydroxycut recall injury lawyers at our firm are committed to making sure that Iovate is held accountable for failing to adequately test this medication.

If you or someone you love suffered from liver toxicity, liver failure, seizure, stroke or heart attack as a result of Hydroxycut, you have valuable legal rights. Please fill out our online form or call 1 800 99 POTTS (1-800-997-6887) as soon as possible to discuss your case with one of our Liver damage injury lawyers.

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The U.S. Food and Drug Administration (FDA) recently released a consumer advisory about certain Hydroxycut-branded products. According to the advisory, the FDA has received 23 reports over more than seven years about consumers having experienced serious liver-related problems coinciding with the time they were taking Hydroxycut-branded products. The advisory states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.”

While this is a small number of reports relative to the many millions of people who have used Hydroxycut products over the years, out of an abundance of caution and because consumer safety is our top priority, we are voluntarily recalling these Hydroxycut-branded products.

The information below answers questions consumers may have about the advisory, the recall, and Hydroxycut-branded products.

What is Hydroxycut?

Hydroxycut is the brand name of some of America’s top-selling weight loss products which are taken by millions of consumers each year. Hydroxycut products are made by Iovate Health Sciences, which has over 750 items sold in more than 70 countries around the world.

What steps do you take to ensure the safety of Hydroxycut-branded products?

We conduct internal analyses of individual ingredients, and undertake extensive medical, scientific and toxicological literature reviews on the safety of the ingredients during the development stage of each product. Additionally, third-party experts from the leading independent scientific firm specializing in ingredient assessment, toxicology and product safety for the nutritional and pharmaceutical industry review the safety of Iovate’s ingredients and formulas before products are introduced in the marketplace. Only after this external review is completed does Iovate release a formula.

What is an adverse event?

The term “adverse event” refers to any unexpected or unintended event that happens while an individual is taking a dietary supplement, whether or not the supplement caused the event. Even minor events can be considered adverse if they are unexpected or unintended.

Which products are covered by this advisory?

The following products are covered by the advisory:

* Hydroxycut Regular Rapid Release Caplets
* Hydroxycut Caffeine-Free Rapid Release Caplets
* Hydroxycut Hardcore Liquid Capsules
* Hydroxycut Max Liquid Capsules
* 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

Does the advisory say I should stop taking Hydroxycut-branded products?

Yes. The FDA’s advisory states that, “Consumers who have these products are urged to stop using them.”

What if I want to return my Hydroxycut product. How do I do that?

For product refunds, consumers are directed to return their product directly to the place of purchase.

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