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: www.fda.gov/MedWatch/report.htm
Regular Mail: Use FDA postage paid form 3500 found at: www.fda.gov/MedWatch/getforms.htm 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

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products.

For More Information
FDA’s Web Page on Hydroxycut Products
www.fda.gov/oc/opacom/hottopics/hydroxycut/

FDA 101: Dietary Supplements
www.fda.gov/consumer/updates/supplements080408.html

(Source: http://www.fda.gov/consumer/updates/hydroxycut050109.html)

• 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

Q. Why are these products being recalled?
A. Hydroxycut products have been associated with potential risk of severe liver injury. FDA has received 23 reports of liver problems in people who used Hydroxycut, some of whom needed liver transplants, and one death has been reported. FDA has learned of several other serious problems that some Hydroxycut users have had, including seizures; rhabdomyolysis (a type of muscle damage that can lead to other serious problems, such as kidney failure); and cardiovascular problems, ranging in severity from irregular heart beat to heart attack.

Q. What is Hydroxycut?
A. Hydroxycut products contain a variety of ingredients, including herbal extracts, chemicals and metals.

Q. How can I find out if other Hydroxycut products are being added to the recall?
A. FDA will provide additional information in future Consumer Alerts, which will be posted on the FDA web site at http://www.fda.gov/oc/opacom/hottopics/hydroxycut/

Q. Can Hydroxycut make me sick?
A. Although the serious liver problems experienced by some people after taking Hydroxycut appear to be rare, anyone taking Hydroxycut products could be at risk. For this reason, FDA recommends that all people stop using Hydroxycut weight loss products.

Q. Are some people at higher risk than others?
A. There is not sufficient medical evidence at this time to make a definitive statement on the risk of one segment of the population over another. It is, however, important to note that even people who had no pre-existing medical conditions have needed liver transplants after taking Hydroxycut.

Q. I’ve been taking Hydroxycut. Should I stop?
A. Yes. FDA recommends that all people stop using Hydroxycut weight loss products.

Q. If I just cut back my dose of Hydroxycut, will that reduce the risk that it could make me sick?
A. No. The amount of Hydroxycut that could cause illness is unknown. Liver injury occurred even when patients said they had taken the doses of Hydroxycut recommended on the bottle.

Q. What are the symptoms I should watch for if I have taken Hydroxycut?
A. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms of liver disease might include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, itching, or loss of appetite.

Q. If I were going to have symptoms, how soon would they appear?
A. Symptoms could have occurred while you were taking Hydroxycut, or they could occur up to several months after you stopped taking it.

Q. What should I do if I develop these symptoms?
A. If you have the symptoms above or develop any other new symptoms after taking Hydroxycut, see your health care provider as soon as possible.

Q. I thought ephedra was banned. Does Hydroxycut contain ephedra, and could that be what caused the illnesses linked to Hydroxycut?
A. The company that makes Hydroxycut states that the current formula does not contain ephedra and that ephedra was removed from Hydroxycut products in 2004. The serious problems that have been occurring do not appear to be due to ephedra.

Q. Are any of the ingredients in Hydroxycut known to cause illness?
A. Based on the information that is available, FDA can’t determine exactly which ingredient or blends of ingredients in Hydroxycut may be associated with liver injury, or what other factors may affect the risks associated with Hydroxycut. These other factors may include, for example, pre-existing medical conditions, length of time Hydroxycut has been used, or use of both Hydroxycut and other dietary supplements or drugs.

Q. I thought Hydroxycut contains natural ingredients. Doesn’t that make it safe?
A. No. “Natural” ingredients don’t necessarily mean that a product is safe. Many substances that come from nature can be toxic.

Q. I still have some Hydroxycut. What should I do with it?
A. You should dispose of any Hydroxycut that you have.

Q. I read that potential problems with Hydroxycut were first reported seven years ago. Why has it taken FDA so long to notify the public?
A. Because liver-related problems associated with Hydroxycut were reported infrequently, several years elapsed before a clear relationship between Hydroxycut and liver disease became discernible. Now that the relationship has been established, FDA is notifying the public and health care providers. In addition, until 2004, Hydroxycut contained ephedra, which subsequently has been removed. It was thought that ephedra may have caused the liver-related problems, but following its removal from the Hydroxycut products, reports of illness continued.

Q. How can I lose weight safely?
A. The safest way to lose weight is to develop a weight-loss plan with your health care provider. To find out more about safe weight loss, visit the following web site offered by the National Institutes of Health: http://win.niddk.nih.gov/publications/choosing.htm.

(Source: http://www.fda.gov/oc/opacom/hottopics/hydroxycut/faq.html)

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 thirdparty 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.

The recalled products are sold in multiple-count caplet and capsule boxes and bottles. The FDA advisory states that, “Consumers who have these products are urged to stop using them.” Iovate is working with the FDA and retailers to ensure that these products are quickly and effectively removed from the market. For product refunds, consumers are directed to return their product directly to the location where it was purchased. Consumers with questions about the advisory or recall can visit www.hydroxycutinformation.com for more information. Consumers can also contact the company by calling 1-877-468-2835 between 9 am and 5 pm Eastern Standard time.

The list of products being voluntarily recalled by Iovate:

HYDROXYCUT RAPID RELEASE REGULAR CAPLETS

631656893649 Hydroxycut 140ct Cap US
631656833621 Hydroxycut 60 GNC US
631656600988 Hydroxycut 300ct Caplets US
631656890129 Hydroxycut 36ct Cap US “with CARDS”
631656282245 Hydroxycut 160ct Cap US *Discontinued*
631656873214 Hydroxycut 58ct Cap US
631656813418 Hydroxycut 70ct Cap US
631656808612 Hydroxycut 70ct Caps US *Discontinued*
631656808117 Hydroxycut 100 cap US *Discontinued*
631656818642 Hydroxycut 140ct Cap US *Discontinued*
631656882414 Hydroxycut 80ct Caps US *Discontinued*
631656843262 Hydroxycut 210ct Cap US
631656828665 Hydroxycut 210 cap US *Discontinued*
631656600582 Hydroxycut 60ct + 1 Hydroxycut Sachet WB US
631656600476 Hydroxycut 72ct + Hydroxycut Sachet WB US
631656600483 Hydroxycut 100ct Caplets US
631656600506 Hydroxycut 150ct Caplets US
631656601251 Hydroxycut 170 Caplets US
631656600452 Hydroxycut 30ct Caplets US

HYDROXYCUT HARDCORE LIQUID CAPSULES

631656600650 Hydroxycut Hardcore 120ct US
631656600834 Hydroxycut Hardcore 210ct US
631656001778 Hydroxycut Hardcore 30ct US
631656601435 Hydroxycut Hardcore 252ct US
631656601848 Hydroxycut Hardcore 30ct US Trial – Bodybuilding.com
631656601749 Hydroxycut Hardcore 120ct US NEW
631656601763 Hydroxycut Hardcore 252ct US
631656601756 Hydroxycut Hardcore 210ct US NEW

HYDROXYCUT CAFFEINE-FREE CAPLETS

631656801224 Hydroxycut Caffeine Free 140ct Cap US
631656821246 Hydroxycut Caffeine Free 330ct Cap US
631656801217 Hydroxycut Caffeine Free 100ct Cap US
631656801231 Hydroxycut Caffeine Free 58ct Cap US
631656899122 Hydroxycut Caffeine Free 36ct Cap US
631656600544 Hydroxycut Caffeine Free 60ct US
631656600551 Hydroxycut Caffeine Free 72ct US
631656600568 Hydroxycut Caffeine Free 100ct US

HYDROXYCUT MAX CAPLETS

631656601466 Hydroxycut Max 120ct bonus + 1Hyd Max Sachet WB US
631656601633 Hydroxycut Max 210ct Bonus + 1 Hyd Max Sachet WB US

HYDROXYCUT REGULAR DRINK PACKET

631656860191 Hydroxycut Weight Loss Drink Mix 21pk Sachet – Wild Berry US
631656860313 Hydroxycut Weight Loss Drink Mix 21pk Sachet – Country Lemonade US

HYDROXYCUT HARDCORE DRINK PACKET (IGNITION STIX)

631656701326 Hydroxycut Hardcore Drink Mix 2.7g Sachet – Blue Raspberry US
631656701319 Hydroxycut Hardcore Drink Mix 2.6g Sachet – Fruit Punch US
631656760118 Hydroxycut Hardcore Drink Mix 40pk x 2g Sachet – Fruit Punch US
631656760125 Hydroxycut Hardcore Drink Mix 40pk x 2g Sachet – Blue Raspberry US

HYDROXYCUT CAFFEINE-FREE DRINK PACKET

631656760095 Hydroxycut Caffeine Free Drink Mix 21pk x 3.6g Sachet – Raspberry Ice US

HYDROXYCUT MAX DRINK PACKET

631656860375 Hydroxycut Max Drink Mix 40pk x 2.4g Sachet – Wild Berry US
631656860382 Hydroxycut Max Drink Mix 40pk x 2.7g Sachet – Lemonade US

HYDROXYCUT LIQUID SHOT

631656800159 Hydroxycut Weight Loss Single Shot 2oz – Wild Berry US
631656860207 Hydroxycut Weight Loss Shot 2 x 2oz Pk – Wild Berry US
631656860498 Hydroxycut Instant Weight Loss Shot 12 x 2oz – Wild berry US

HYDROXYCUT MAX AQUA SHED

631656601855 Hydroxycut Max Aqua Shed 60ct Capsules US

HYDROXYCUT HARDCORE RTD

631656860436 Hydroxycut Hardcore 4 x8oz RTD – Grape Infusion US
631656860399 Hydroxycut Hardcore 4 x 8oz RTD – Triple WildBerry US
631656860665 Hydroxycut Hardcore 12-pack RTD – Grape Infusion US
631656860467 Hydroxycut Hardcore 3 x 4-pack RTD – Grape Infusion US
631656860443 Hydroxycut Hardcore 3 x 4-pack RTD – Triple Wildberry US
631656860443 Hydroxycut Hardcore 3 x 4-pack RTD – Triple Wildberry US
631656860568 Hydroxycut Hardcore 12-pack RTD – Triple Wildberry US

HYDROXYCUT 24

631656600933 Hydroxycut 24 (96 caps/ blister pack) US

HYDROXYCUT CARB CONTROL

631656800036 Hydroxycut Carb Control 58ct Cap US
631656800029 Hydroxycut Carb Control 100ct Cap US
631656800012 Hydroxycut Carb Control 140ct Cap US

HYDROXYCUT NATURAL

631656600889 Hydroxycut Natural 100ct US

Please note that Hydroxycut Hoodia and Hydroxycut Cleanse products are not included in this recall; nor are any other Iovate products.

Source: http://www.fda.gov/oc/po/firmrecalls/iovate05_09.html

Specifically, the dangerous side effects include:

• Seizures from Hydroxycut
• Hydroxycut liver failure
• Cardiovascular disorders
• Kidney failure
• Rhabdomyolysis from Hydroxycut

Unfortunately, as serious as these side effects are, they are not the most dangerous ones associated with this product line to this point.

Those side effects include several different types of liver damage, including jaundice and raised levels of enzymes in the liver, which can lead to irreparable liver damage and ultimately the need for a liver transplant.

The FDA Responds…

As a result of these reports, the US Food and Drug Adminstration (FDA) has recently released a statement that leaves no room for doubt in regards to the severity of the problem.

In the statement, the FDA warned all consumers to stop using these products immediately, and that an investigation was beginning to attempt to determine the cause of these side effects. At this point, no central cause has been identified, but the risks are severe enough that the FDA has overtly requested the use of Hydroxycut to stop.

Dietary Supplements Linked to One Death; Pose Risk of Liver Injury

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 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.

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.

“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.

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

-Online: www.fda.gov/MedWatch/report.htm
-Regular Mail: Use FDA postage paid form 3500 found at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
-Fax: 800-FDA-0178
-Phone: 800-FDA-1088

The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.