Questions and Answers: Hydroxycut

Q.  Which Hydroxycut products are being recalled?

A.  Hydroxycut products are dietary supplements, marketed for weight loss and as fat burners, that bear the Iovate or Muscletech brand name.  The 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.

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 on the Hydroxycut Products page.

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?

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 Choosing a Safe and Successful Weight-loss Program web site offered by the National Institutes of Health.