Letter to Healthcare Professionals on the Potential Risk of Severe Liver Injury from the Use of Hydroxycut Dietary Supplements

Dear Health Care Professional Colleague:

We are alerting you about a dietary supplement product that we believe presents a serious public health risk. Hydroxycut products are distributed by Iovate Health Sciences Inc., Oakville, Ontario Canada and distributed by Iovate Health Sciences U.S.A., Inc. of Blasdell, NY, and have been implicated in several cases of serious liver injury. The Food and Drug Administration (FDA) has received 23 reports of adverse liver effects in users of Hydroxycut products, ranging from asymptomatic hyperbilirubinemia, jaundice, liver damage, liver transplant, and death. The injuries reported to FDA occurred in persons between 21 and 51 years of age. No other cause for liver disease was identified. In the majority of cases, no preexisting medical condition that would predispose the consumer to liver injury was identified. In some cases, discontinuation of Hydroxycut usage resulted in recovery of liver function. Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk. FDA has also identified several other serious adverse events associated with Hydroxycut, including cases of seizures, rhabdomyolysis, and cardiovascular disorders ranging in severity from palpitations 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, 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;
• Hydroxycut Carb Control; and
• Hydroxycut Natural.

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.

FDA is warning consumers to immediately stop use of these products. FDA has issued a consumer warning advising of the potential risks associated with the use of these products and advising consumers to consult their health care provider if they are experiencing symptoms possibly associated with this product, particularly nausea, weakness or fatigue, fever, abdominal pain, or any change in skin color.

We urge you to review your cases of hepatitis in order to determine if any may be related to the use of dietary supplements in these patients. Adverse events associated with the use of dietary supplements should be reported as soon as possible to FDA's MedWatch program by telephone (1-800-332-1088) or Internet (FDA Medwatch).

Thank you for your efforts and cooperation in addressing this potentially serious public health issue. For additional information, contact the FDA Center for Food Safety and Applied Nutrition.