Hydroxycut Weight Loss Lawyer Blog

The medical studies, literature and the experience of our office indicate that one can be on Hydroxycut for a relatively short period of time before the onset of symptoms.

At the Onder Law Firm, we have found that our clients fall into both the long and short term use categories.  While many of our clients have been using Hydroxycut on a more long term basis, others have taken the Hydroxycut product for but a few days before experiencing an onset of problems.

Although dietary and herbal supplements are governed under the DSHEA Act of 1994, they are not presently regulated by the United States Food & Drug Administration, and the safety of many such supplements are unknown.

Unfortunately, absent FDA approval, the dietary and herbal supplement industry is largely unregulated, and Hydroxycut and many other supplements have been increasingly associated with liver and kidney failure.

There is definitely a need for greater regulation of this medical sector.  Through political actions and the legal system, the Onder Law Firm is working with other leaders in pursuit of more stringent regulations upon the dietary and herbal supplement industry.  While most herbal supplements are good, we must have adequate regulation to ensure that the public is not harmed by unsafe products.

This question has not been fully answered by medical research and the medical community.  However, there are three elements contained in some Hydroxycut products which have been known to cause problems.

There have been a growing number of case reports of liver toxicity associated with the weight-loss supplement Hydroxycut, so named because it contains hydroxycitic acid from the tropical fruit Garcinia Cambogia, which is potentially toxic to the liver.

Other medical studies have suggested that the green tea extract Camellia Sinensis is the cause of acute liver injury in the weight-loss supplement Hydroxycut.  Indeed, Camellia Sinesis, contained in the weight-loss supplement Exolise (Arkophama, Carros, France) was implicated in liver toxicity in numerous European case reports leading to the product’s withdrawal from the market.  Camellia Sinensis has also been associated with acute liver injury in another herbal supplement marketed as The Right Approach (Pharmanex, Provo, Utah).

Still other physicians implicate chromium as the potential cause of problems.  Chromium is an essential trace element and co-factor to insulin most commonly occurring in Hexavent (IV) and Trivalent (III) states.  The Hexavent form of chromium is found in the dye and leather industry and has been linked to occupational toxicity ranging from Dermatitis to lung cancer.

In 1989, the National Academy of Sciences established an “estimated safe and adequate daily dietary intake” range for chromium of 50-200 mg.  In 2001, the Institute of Medicine and the National Academy of Sciences established Dietary Reference Intakes for chromium, ranging from 0.2 mg for infants to a maximum of 45 mg for lactating mothers.  There have been case reports of chromium toxicity causing acute hepatitis, thrombocytopenia and renal failure due to both environmental and dietary supplements.  Each Hydroxycut serving contains 133 mg of chromium, which is taken three times daily, resulting in accumulative daily consumption greater than twice the National Academy of Science’s maximum safe dose.

In summary, three of the ingredients contained in many Hydroxycut products have been associated with significant medical problems.  At the Onder Law Firm, we take pride in the depth of our available medical resources and look forward to evaluating the particulars of your claim to determine the root cause of the problem in your particular situation.

Reports of individuals being harmed by the dangerous chemicals in Hydroxycut date back to 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.

 
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 (in May 2009) 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 publicC people could have been saved from liver or kidney damage.  The most disturbing problem is that Hydroxycut 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!

At the Onder Law Firm, we stand committed to righting the wrongs caused by such false representations by the manufacturer of Hydroxycut.  We welcome the opportunity to review the particulars of your claim in an attempt to seek adequate compensation for the wrong that has been done to you.

The damage associated with Hydroxycut induced kidney and liver failure can vary dramatically.

Hydroxycut induced medical conditions will often cause permanent scarring in the liver and kidneys.  While blood tests and blood enzymes levels may return to normal, the individual is generally at risk for long term problems, including both kidney and liver failure.

However, the long term risk of each patient can vary.  In order to assess your particular risk, we would suggest that you consult with your treating physicians.  In addition, our medical team at the Onder Law Firm stands ready and able to discuss with you the particulars of your situation.

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.

“Proprietary Blend” is what companies do to mask the amount of each ingredient that is included in the product.  While drugs like Hydroxycut do reveal the ingredients themselves, they DO NOT show how much of each ingredient is used.

This is where the problem lies.

Companies often include a list of well rounded ingredients to appear more legitimate or “healthier”.  However, in reality they often include these ingredients in small amounts.  Ingredients that can be harmful in large amounts, such as caffeine, can make up the majority of the drug.

If you have been injured from taking Hydroxycut, visit www.hydroxycutinjury.com for more information.

While the FDA monitors drug safety, surprisingly (and sadly), the voice of the consumer may be the only real regulatory system for dietary supplements.  This means if you’ve been injured by Hydroxycut, you MUST speak up!

Federal law requires supplement manufacturers to report serious adverse effects to the Food and Drug Administration, but it depends on consumers to call in reactions. Experts say most consumers are unlikely to relate health problems to a supplement they assume to be safe, and even if they do, they may be reluctant to report an adverse effect from a self-medicated substance.

In 2008, the New York Times reported “No one knows how many such adverse effects befall supplement users, because there has been no reliable reporting system.”

A National Institutes of Health panel in May 2006 noted: ”The F.D.A. has insufficient resources and legislative authority to require specific safety data from dietary supplement manufacturers or distributors before or after their products are made available to the public. The constraints imposed on F.D.A. make it difficult for the health of the American public to be adequately protected.”

If you’ve been injured from using Hydroxycut, your voice needs to be heard.  After all, you’re the regulatory system!

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