FDA: Stop Using Hydroxycut

Medical Author: Melissa Conrad Stöppler, MD
Medical Editor: William C. Shiel Jr., MD, FACP, FACR

Hydroxycut weight-loss supplements have been linked to serious medical problems, including one death, according to the United States Food and Drug Administration (FDA) warning issued on May 1, 2009. In all, 23 reports were received by the FDA of serious health problems that developed in people using Hydroxycut products, including serious liver injury, seizures, cardiovascular disorders, and rhabdomyolysis, a dangerous type of muscle damage. One death, due to liver failure, has also occurred.

Liver injury was previously listed as possible side effect of Hydroxycut. Symptoms of liver failure or liver dysfunction are jaundice, dark urine, nausea and vomiting, itching, loss of appetite, fatigue, and abdominal pain.

Hydroxycut is manufactured by Iovate Health Sciences, Inc. According to the company Web site, Iovate manufactures over 750 items that are sold in over 70 countries. The FDA warning affects only Hydroxycut products, which, according to Iovate, are taken by millions of consumers each year. Iovate has agreed to recall Hydroxycut products from the market.

Hydroxycut has raised doubt in the minds of consumers in the past. Its original formulation contained ephedra (ma huang), a substance that was banned by the FDA in April 2004 due to reported serious side effects and deaths associated with its use. Now the "new" formulation of Hydroxycut also appears to be unsafe. While the company's online information on Hydroxycut has been taken down due to the FDA warning, retailer sites indicate that the "new" (post-ephedra) formula is based upon a substance referred to as Hydroxagen, a blend of an extract from the plant Garcinia cambogia and other ingredients. The active ingredient in Garcinia cambogia, hydroxycitric acid (HCA), is claimed to have carbohydrate-blocking properties. Although a few studies have suggested a weight-loss benefit for Garcinia cambogia extract, the evidence is far from conclusive.

Weight-loss supplements, such as Hydroxycut, will remain on the market as long as there are millions of people looking for a "quick fix" or a way to "trick" their system into losing weight at an accelerated pace. But the long-term safety of these products has never been established, and their effectiveness has not been proven in independent, controlled clinical trials.

It may not be the answer everyone wants to hear, but the safest weight loss occurs by following a physician-supervised healthy eating and exercise plan. Those with significant obesity may want to discuss the use of an FDA-approved prescription weight-loss medication with their health-care professional. Meridia and Xenical are the only weight-loss drugs approved for longer-term use in significantly obese people, but even the safety and effectiveness of these products have not been established for use beyond two years. If you're taking Hydroxycut products (see the FDA advisory for the list of affected products), the FDA urges you to stop now and return them to the place of purchase. If you're taking Hydroxycut and believe you may have symptoms associated with its use, contact your health-care professional for an evaluation.

Reference: FDA news, May 1, 2009: http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html