Hydroxycut Weight Loss Lawyer Blog

Absolutely not.  The medical literature is replete with case studies involving young relatively healthy individuals experiencing kidney and liver failure while taking doses recommended by the manufacturer.

While it is certainly possible that some individuals may have overdosed and such could have caused problems, the FDA has acted based upon medical and scientific research and case studies involving individuals who have had serious health problems while taking the dose recommended by the manufacturer.

At the Onder Law Firm, our experience has been consistent with that of the United States Food & Drug Administration.  Our clients have generally taken the Hydroxycut product within the dosage recommendation of the manufacturer.

FOR IMMEDIATE RELEASE — (May 7, 2009) — Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is adding Universal Product Codes (UPCs) with respect to the Hydroxycut-branded products sold in the United States and subject to the voluntary recall.  These additions all involve additional packages and sizes of products previously referenced.  

The UPC numbers being added to the May 1 list are as follows:

-631656800265 Hydroxycut Hardcore 8 fl. oz. Grape Explosion
-631656800210 Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
-631656001501 Hydroxycut 280ct-3 Pak Kit *Discontinued*   
-631656001563 Hydroxycut 280ct-6 Pak Kit *Discontinued*   
-631656000658 Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit   
-631656600896 Hydroxycut 2×60ct Club Pack US Kit  
-631656000672 Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit *Discontinued*   
-631656874693 Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
-631656000665 Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit *Discontinued*
-631656002362 Hydroxycut Sachet Twin Pack US Kit   
-631656860498 Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit   
-631656660623 Hydroxycut Hardcore Shredded Stack Kit120ct
-631656500585 Hydroxycut 60 Rapid Release Caplets

Iovate initiated a voluntary recall when it became aware that the U.S. Food and Drug Administration’s assessment of 23 reports about consumers having experienced liver-related problems, as well as a small number of published case reports, was different from Iovate’s analysis.  On May 1, 2009, the FDA issued an advisory which states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.”  The number of adverse event reports described by the FDA is small relative to the many millions of people who have used Hydroxycut products over the 7 years referenced by the FDA.  Iovate’s own assessment of the potential risk associated with the use of these products differs from that expressed by the Agency.  Every product marketed by Iovate is evaluated during its development for the safety of its individual ingredients.  Additionally, independent 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.

However, out of an abundance of caution and because consumer safety is Iovate’s top priority, Iovate is voluntarily recalling these Hydroxycut-branded products.

Consumers with questions about the recall can visit www.hydroxycutinformation.com for more information.  Consumers can also contact the company by calling 1-877-468-2835 Monday through Friday between 9 am and 5 pm Eastern Daylight Time.

Unfortunately, the previous blog posting wasn’t the only incident of individuals being harmed by Hydroxycut.  Our medical research has been ongoing, and we know of many additional instances of individuals harmed by Hydroxycut.  The scary part is that these are otherwise healthy, young people, even people that participate in body-building competitions!   And what’s worse is that they suffered injuries while taking the dose recommended by Hydroxycut.  This isn’t a situation where out of shape people were overdosing on the product.   These are healthy people that took the recommended dose and suffered catastrophic injuries.

The injuries people have suffered from Hydroxycut range from liver damage to kidney damage to muscle damage (rhabdomyolysis) to seizures.  This is not limited just to liver injury.  Below we summarized some of the medical research and literature to give you a better idea of the serious injuries caused by Hydroxycut. 

Acute Liver Injury Associated with the Herbal Supplement Hydroxycut in a Soldier Deployed to Iraq

This report was issued in 2007 following an acute liver injury suffered by a U.S. Army soldier in Iraq.  The 19 year old male soldier reported to the troop medical clinic with complaints of six days of nausea and vomiting.  He did not have pre-existing medical problems, did not use prescription medications, did not have a personal or family history of hepatitis, jaundice or other liver problems, had not consumed alcohol for six months, and had not undergone a blood transfusion.  However, he had been using Hydroxycut for weight loss for approximately four months prior to reporting to the medical clinic.

Tests revealed that the soldier was jaundiced and that he was suffering from acute liver injury (hepatoxicity).  The doctors with the Eisenhower Army Medical Center concluded that the soldier developed acute liver injury from Hydroxycut.  They reported that green tea extract (Camellia sinensis), one of the ingredients in Hydroxycut, had been associated with acute liver injury in other weight loss supplements and tonics.  Due to the fact that herbal weight loss supplements that contain green tea leaf extract, such as Hydroxycut, had been associated with acute liver damage, the doctors urged caution in the use of those products.

The American Journal of Gastroenterology (2007) 102, 2357-2358.

Hydroxycut Hepatotoxicity: A case series and review of liver toxicity from herbal weight loss supplements

This article discusses two individuals that reported to an emergency room with similar problems.  A 40 year old female went to the emergency room with crampy abdominal pain and diarrhea.  She also complained of nausea and vomiting, profound fatigue and fevers and chills.  One week prior to going to the ER, she began using six pills per day of Hydroxycut in preparation for a body building competition.  She took no other medications or dietary supplements and did not have previous liver problems.  A 33 year old female presented to the emergency room complaining of jaundice, nausea, crampy abdominal pain and profound fatigue.  She did not drink alcohol and was on no other relevant medications. She also had no previous liver problems.  However, she had been taking Hydroxycut for two weeks to help her achieve weight loss, but stopped taking it after onset of the symptoms.  In both cases, the tests revealed that these women were suffering from acute chemical liver damage.

The doctors writing the article noted that Hydroxycut contains several different herbs, including Garcinia Cambogia extract, chromium polynicotinate, Gymnema Sylvestre extract and Camellia Sinenesis (green tea leaf extract).  The doctors concluded that the close time relationship between the ingestion of the Hydroxycut and the liver toxicity suggested that Hydroxycut was the cause of the liver damage.

Interestingly, the doctors noted that chromium, an ingredient in Hydroxycut, is an essential trace element and cofactor to insulin most commonly occurring in hexavalent (VI) and trivalent (III) state.  It noted that the hexavalent form is found in the dye and leather industry and is responsible for occupational toxicity ranging from dermatitis to lung cancer.  It further noted that the National Academy of Sciences (NAS) had established that the safe adequate and daily dietary intake range for chromium was 50-200 mg per day.  However, each Hydroxycut serving contains 133 mg of chromium, which if taken three times daily as recommended, results in a cumulative daily consumption greater than twice the NAS safe maximum dose. 

The doctors further noted that another ingredient in Hydroxycut, Camellia Sinenesis, is commonly known as green tea leaf extract and is regarded as safe by the public.  However the doctors note that this Hydroxycut ingredient is well described as a cause of acute hepatitis and acute liver failure.  It should be noted that this Hydroxycut has been banned in France and Spain, although it remains unregulated in weight loss supplements commercially available in the U.S.

The doctors  noted the potential for acute liver injury caused by herbal supplements including Hydroxycut.

Dara, L., et al. World J. Gastroenterol 2008 December 7; 14 (45): 6999-7004

Severe hepatoxicity due to Hydroxycut: A case report

In this report, a 28 year old male was transferred to the UCLA emergency room complaining of three weeks of fatigue, jaundice and dark urine.  In an effort to lose weight, he had been taking two tablets of Hydroxycut 2-3 times per day, which is within Hydroxycut=s suggested dosing.  The 28 year old had no history of liver disease and rarely drank alcohol.  Upon testing, it was noted that he was suffering from acute liver damage.  The physicians concluded that his acute liver injury was consistent with hepatoxicity associated with Hydroxycut.  As a result, the physician stated that caution should be exercised by consumers using Hydroxycut, since there was evidence that extracts of Garcinia Cambogia, Gymnema Sylvestre and Camellia Sinensis contained in Hydroxycut may be associated with severe and even fatal acute liver injury.

Shim, M. Dig Dis Sci (2009) 54: 406-408

Rhabdomyolysis associated with the nutritional supplement Hydroxycut

An 18 year old man arrived at an Urgent Care Center complaining of leg pain and weakness.  He was diagnosed with rhabdomyolysis and instructed to go to the emergency room.  Rhabdomyolysis is a syndrome characterized by muscle necrosis, whose severity can range from muscle aches to life threatening situations.  It is commonly caused by trauma, drugs or toxins, infections, or metabolic etiologies.  It can become life threatening, causing hepatic inflammation, cardiac arrhythmia and arrest, acute renal failure, and other serious medical conditions.

The patient had no significant past medical history.  Before his symptoms started, he had been taking four caplets of Hydroxycut daily.  The physicians concluded that due to the fact that he had no significant medical history, it was likely that the rhabdomyolysis was associated with taking the Hydroxycut in addition to his increased exercise regimen.

Dehoney, S. et al. Am J Health B Syst Pharm B Vol. 66 January 15, 2009 142-148

There have been individuals harmed by the dangerous chemicals in Hydroxycut since at least 2005.  The medical literature reveals some eye-opening research regarding the injuries caused by Hydroxycut.  For instance, there is a report of a 27 year old man and a 30 year old man who went to an emergency room complaining of eight days’ worth of fatigue, jaundice, fever, and vomiting.  These people were previously healthy, had not been out of the country, were not around other sick individuals, and had no risk factors for liver disease.  Except for Hydroxycut, they had not recently taken any herbal or prescription medications.

After extensive testing, it was discovered that both of the individuals were suffering from Hepatotoxicity, which chemically caused their acute liver failure.  The doctors with the Cleveland Clinic Foundation determined Hydroxycut ingestion caused the liver damage.  The doctors concluded that the evidence for the usefulness of Garcinia Cambogia, one of the ingredients in Hydroxycut, in promoting weight loss was not compelling and urged caution in use of Hydroxycut.  This was in 2005, yet Hydroxycut is only now being recalled and pulled from the market.

This probably comes as a surprise to many people that injuries were being caused by Hydroxycut as many as four years ago.  It is appalling that these results weren’t made public, people could have been saved from liver or kidney damage.  The most disturbing problem is that Hydroxycut itself didn’t warn its customers about the possibility of injuries resulting from the use of its product.  Instead, it continued to tell customers to put their Trust in Hydroxycut because of its fine, quality ingredients.  Ingredients that cause liver and kidney damage don’t sound like fine quality to us!

Unfortunately, those trying to improve their health by losing weight and/or exercising may have been at risk the most, as this group makes up the majority of Hydroxycut customers.

The U.S. Food and Drug Administration warned dieters and body builders against using Hydroxycut dietary supplements after it received reports linking some of the widely sold Canadian-made products to cases of serious liver damage and at least one death.

Hydroxycut is used by people trying to shed pounds and by body builders to sharpen their muscles.

At least nine million packages were sold last year, the FDA said.

Hydroxycut accounts for about 90 percent of the market for weight loss supplements.

The following is a list of supplements currently sited in recall of Hydroxycut due to it causing liver damage and other serious injuries:

• 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

Resource: www.hydroxycutliverfailure.com

Hydroxycut is used to remove fluid from the body. With less hydration, fat will decrease visibly in size because there is no water in it.  The fat does, however, remain…it just appears like less fat. With less hydration the skin will cling more closely to the muscle beneath it.

It is not good for daily use, when the body is deprived of hydration the liver can not flush itself properly and a series of problems can begin. Over time, common toxins like uric acid can attack the liver because it can not be moved to the bladder.  This then leads to liver damage. 

If you’ve used Hydroxycut daily, and experience any symptoms of liver damage, consult your physician immediately.

Weight loss is never easy; it takes a lot of determination and hard work in order to reach your goals the right and healthy way.  It’s a struggle for many, and unfortunately Lovate Health Sciences has taken advantage of the public, but at a large price for what is represented as such a small magical pill. 

Life threatening liver problems have been reported and linked to even the mere recommended dose for the many forms of Lovate’s weight loss supplements, Hydroxycut.  Several cases have been reported, at least one being fatal and several requiring liver transplants.  But the problems don’t end there; other reported health problems include seizures, cardiovascular disorders, kidney failure, and organ deteriorating muscle damage.

Unfortunately, advertising for Hydroxycut is very convincing; making consumers believe that all you need is their product to help you in weight loss success.  Just take Hydroxycut and the pounds will just melt off!  But have you ever noticed the fine print, the small words at the bottom of the screen that says “results not typical?”  This should be the first sign that the supplement cannot be trusted.

Lovate Health Sciences has been deceivingly making money off of the Hydroxycut for YEARS, and at the expense of the health of consumers.  And until now they have been legally able to do so!  This industry is unregulated, allowing companies like Loveate to put anything into their “magical” products, allowing them to immorally market these dangerous products, and keep their products on shelves nationwide.  Only when people die is something done to stop these companies from hurting more people.

Hydroxycut is one of the most popular weight-loss supplements available. However, even though Hydroxycut is very popular, there is a lack of reliable scientific evidence to support the claim that the supplement is effective for weight loss.  Now, as reports of Hydroxycut causing liver damage come into light, the lack of scientific evidence surrounding this product raises even more concern.

Although a few studies support the effectiveness of Hydroxycut, it is important to note that these studies are small and evaluate only some of the ingredients in Hydroxycut (not all of the active ingredients in the current formulation). With studies of such small size, it is possible that the results could be caused by mere chance.

As this new announcement about Hydroxycut causing liver damage unfolds, more scientific studies should shed light on both the effectiveness AND harm of this drug.

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 Hydroxycut 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.

Hydroxycut Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of Hydroxycut 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.

www.hydroxycutrecallinformation.com