Reports of severe liver injuries—including one fatality—associated with Hydroxycut brand dietary supplements have prompted a nationwide product recall, the Food and Drug Administration announced last month. The products are marketed as weight-loss aids, energy-enhancers, low-carbohydrate diet aids, and diuretics.
The 23 reports of hepatic injuries have been in people aged 21–51 years, with no other identifiable cause for liver diseases and who have not appeared to be related to duration of use or dose. Included are cases of asymptomatic hyperbilirubinemia, jaundice, liver damage, liver transplant, and one death—a 19-year-old previously healthy male in 2007 in the U.S. Southwest. The outcome of another patient with liver failure who was on a transplant list is not known, the FDA said in a press briefing to announce the recall. In some cases, stoppage of Hydroxycut consumption resulted in recovery of liver function.
“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,” the FDA advised in a letter to health care professionals. In most cases, people had no identifiable preexisting medical condition that would predispose them to liver injury. There also have been reports of people with nonhepatic serious side effects associated with use of the products, including seizures, cardiovascular disorders ranging from palpitations to a heart attack, and rhabdomyolysis.
The recall covers 14 different products with the Hydroxycut name, including Hydroxycut Regular Rapid-Release Capsules, Hydroxycut Hardcore Liquid Caplets, Hydroxycut Caffeine-Free Drink Packets, and Hydroxycut Carb Control. Two Hydroxycut products—Hydroxycut Cleanse and Hoodia—which have completely different ingredients, are not affected by the recall, the FDA said.
Although liver damage associated with use of these supplements “appears to be relatively rare,” the FDA is warning consumers to immediately stop using these products, which are sold widely in supermarkets, health food stores, online, and on television. Ontario-based manufacturer Iovate Health Sciences Inc. has told the FDA that 2008 sales totaled more than 9 million units of Hydroxycut products, the agency said.
The precise cause of liver damage has not been identified, because the products contain herbs, herbal extracts, chemicals and metals, and other “overlapping” ingredients, making it difficult to pinpoint the specific ingredient or combination of ingredients that cause liver damage, Dr. Linda Katz, interim chief medical officer at the FDA's Center for Food Safety and Applied Nutrition (CFSAN), said during the briefing.
While most of the other 23 reports of Hydroxycut-related liver injury were made known to the FDA before the passage of the legislation, the agency said the rule allowing the agency to inspect the company's adverse event reports directly has been helpful in its investigation. Such inspection is “something we could not do before,” said Vasilios Frankos, Ph.D., director of CSFAN's Division of Dietary Supplement Programs. For information, go to the FDA's Med Watch Web site at www.fda.gov/medwatch/safety/2009/safety09.htm#Hydroxycut