FDA Warns Consumers Not to Use Dietary Supplements Labeled Hydroxycut because of the Potential Risk of Severe Liver Injury
The Food and Drug Administration (FDA) is advising consumers of the potential risk of severe liver injury associated with the use of Hydroxycut dietary supplements distributed by Iovate Health Sciences Inc., Oakville, Ontario Canada and distributed by Iovate Health Sciences U.S.A., Inc. of Blasdell, NY. The FDA is warning consumers to immediately stop use of the product. Consumers who use a Hydroxycut dietary supplement and who experience signs of illness associated with liver disease should immediately consult their health care provider. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Non-specific symptoms of liver disease can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, itching, and loss of appetite.
FDA has also identified several other serious adverse events associated with Hydroxycut, including cases of seizures, rhabdomyolysis (a type of muscle damage that can lead to other dangerous problems, such as kidney failure), and cardiovascular problems, ranging in severity from irregular heart beat to a heart attack.
Hydroxycut products bear the Iovate or Muscletech Brand name and are multi-ingredient dietary supplements marketed for weight loss, as fat burners, as energy enhancers, as low carb diet aids, and to promote water loss. The following products have been recalled by the company:
- 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 and;
- Hydroxycut Carb Control;
- Hydroxycut Natural.
Consumers who have these products are urged to stop using them.
FDA has received 23 reports of adverse liver effects in users of Hydroxycut products, ranging from asymptomatic blood liver enzyme changes, jaundice, liver damage, liver transplant, and death. In addition, we are aware of four case reports in the medical literature involving six patients who were diagnosed with serious liver disease and who had consumed Hydroxycut. Based on the information available to FDA, we cannot determine exactly which ingredient(s) or proprietary blends in Hydroxycut may be associated with liver injury, or what other factors, such as health condition, length of use, dosage, or use along with other dietary supplements or drugs, may affect the risk of using Hydroxycut.
Furthermore, FDA has not been notified that any of the marketed Hydroxycut products contain New Dietary Ingredients which would require FDA notification. Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.
FDA urges consumers and their health care professionals to report any cases of liver and other injuries that may be related to the use of Hydroxycut or any other dietary supplements. Adverse events associated with the use of dietary supplements should be reported as soon as possible to FDA’s MedWatch program by calling their toll-free number (1-800-332-1088) or through the Internet (FDA MedWatch).
FDA will continue to investigate the relationship between the use of Hydroxycut dietary supplements and liver injury. The Agency’s investigation includes attempting to determine a biological explanation for the relationship. The Agency will alert consumers, and if warranted, take additional action as more information becomes available.
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