WebMD Medical News
Louise Chang, MD
May 1, 2009 -- Fourteen Hydroxycut products, marketed as fat burners, low-cost diet aids, and energy enhancers, are being recalled voluntarily by the manufacturer after the FDA received 23 reports of serious liver injuries ranging from jaundice to death.
The FDA announced the recall today at a news conference.
The recalled products include:
At the news conference, Linda Katz, MD, interim chief medical officer of the FDA's Center for Food Safety and Applied Nutrition, said the agency urges consumers to discontinue use of the Hydroxycut products. Not affected by the recall are Hydroxycut Cleanse and Hoodia products.
The 23 reports of adverse effects include liver damage, elevated liver enzymes (which indicates potential liver damage) and liver damage requiring a transplant. A 19-year-old man died after using Hydroxycut. "The death occurred in 2007," Katz says, "and was reported to the agency at the end of March 2009."
"Hydroxycut products contain a variety of ingredients and herbal extracts," Katz said. The FDA has not yet determined which ingredients or doses are associated with the liver problems, according to Katz.
Other reported health problems include cardiovascular problems, seizures, and serious muscle damage (rhabdomyolysis) that can cause kidney failure.
A message on the toll-free number of Iovate Health Sciences USA Inc. lists the recalled products. Jamie Moss, a spokesperson for the company, says the company is issuing a statement.
The statement also says that the company conducts internal analyses of individual ingredients and medical, scientific and toxicological literature reviews on the safety of product ingredients.
On its web site, the company has posted a statement along with answers to common questions. In part, it says: “While this is a small number of reports relative to the many millions of people who have used Hydroxycut products over the years, out of an abundance of caution and because consumer safety is our top priority, we are voluntarily recalling these Hydroxycut-branded products.”
The reports of liver problems and other ill effects associated with the product use don’t prove cause and effect, says John Hathcock, PhD, vice president of scientific and international affairs for the Council for Responsible Nutrition, a Washington, D.C.-based trade association for the dietary supplement industry.
"Right now it's a simple association," he tells WebMD. Only further investigation will determine if the association is a random occurrence or not, he says.
Tod Cooperman, MD, president of ConsumerLab.com, an independent organization that evaluates dietary supplements, has been testing Hydroxycut products. He hasn't issued a report on them yet.
Cooperman agrees it's difficult to pinpoint which ingredients are to blame. "The products contain many ingredients,'' he says.
The FDA advises consumers who have any of the products involved in the recall to discontinue use immediately and return them to the place of purchase. Though not all the recalled products have been linked with serious liver-related adverse reactions, the company agreed to recall the 14 products, according to the FDA.
SOURCES:Linda Katz, MD, interim chief medical officer, FDA Center for Food Safety and Applied Nutrition.FDA news conference, May 1, 2009.Tod Cooperman, MD, president, ConsumerLab.comIovate Health Sciences USA Inc.Jamie Moss, spokesperson, Iovate Health Sciences USA Inc.John Hathcock, PhD vice president, scientific and international affairs, Council for Responsible Nutrition, Washington, D.C.News release, FDA.
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