FDA Warns Hydroxycut Associated with Liver Injury; Manufacturer Recalls Hydroxycut Products from the Market

The FDA Issued a warning this morning to advise consumers of Hydroxycut products to stop using the products IMMEDIATELY as there is indication some of the Hydroxycut products are associated with a number of serious liver injuries. The Wall Street Journal reports that the FDA has received 23 serious reports of health problems with Hydroxycut products, such as jaundice and elevated liver enzymes, to liver damage requiring a liver transplant, as well as one death of a 19 year old male due to liver failure. Other health issues reported while taking the supplements include seizures, heart problems, and rhabdomyolysis, a muscle damage condition that can cause kidney failure. Symptoms of liver damage as reported by the FDA include jaundice, brown urine, nausea, vomiting, light-colored stools, excessive fatigue, weakness, itching and loss of appetite. The products are generally marketed as “fat burners” and “energy enhancers”.
Apparently as a result of the issuance of this warning by the FDA, the manufacturer of Hydroxycut products has agreed to voluntarily recall 14 of its products including Hydroxycut Regular Rapid Release Caplets, Caffeine-Free Rapid Release Caplets, Hardcore Liquid Caplets, Max Liquid Caplets, Regular Drink Packets and Max Drink Packets. For a complete listing of all Hydroxycut products being recalled, see the FDA’s website. The Hydroxycut Cleanse and Hoodia products are not being recalled because they do not contain the same type of ingredients as the products which have been shown to be problematic.
It is important to understand that unlike pharmaceutical drugs, dietary supplements such as the Hydroxycut products do not need to prove to the FDA that the products are safe and effective before they are marketed. The FDA can only look at the effects of the product once it is being sold and relies on voluntary reports of problems. The manufacturer is not required to advise of potential problems they have been told about with the supplement.
At this point it is still unclear what substance in the Hydroxycut products being recalled is associated with causing the liver damage. The L.A. Times reports that a medical journal last month raised questions about an ingredient in the products called hydroxycitric acid, which is derived from tropical fruit. The article indicated that this ingredient could damage the liver.
Over the past 10-15 years, as I have focused more on my own fitness and health, I have from time to time tried various supplements. Although I have never used any Hydroxycut products, I have used others and there are two things I learned; yes they do work sometimes, and just because they are referred to as “dietary supplements”, does not mean they are safe. As indicated above, the safety testing the FDA requires before marketing for pharmaceutical drugs is not required, thus leaving open the real risk that a supplement can cause a serious adverse effect such as being described with Hydroxycut. Bottom line when considering whether to take a supplement, do all your homework, including investigating what information may be available online, before you take the plunge.
If you have any thoughts or concerns regarding this recall, including issues of potential injury from taking one of the recalled Hydroxycut products, please contact me.