Posted on 05/03/2009 12:10:36 PM PDT by Maelstorm
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:
* 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 * Hydroxycut Natural
Hydroxycut and Liver Problems
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. Hydroxycut Recall: Industry Response
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.
The best otc supplement that has been shown to help prevent liver disease is ALA.
http://www.townsendletter.com/Dec2007/alphalipo1207.htm
Here is the link to the ALA info if anyone is interested.
http://www.townsendletter.com/Dec2007/alphalipo1207.htm
more scare mongering from the FDA. i never used the stuff, but apparently (based off of sales) millions have and only 23 reports of liver injury and one death. The numbers don’t add up to a wholesale recall/ban. Why not just warn people about the potential dangers?
There may be individuals unusually sensitive to the product. More likely somebody ODed or took this with something else and had a bad interaction. This is like ephedra.
you are correct...this is another attempt to take over the supplement industry ....many of the OTC supplements are more effective then the sh*t the government dishes out..hence they have to ban it..or take it over to tax it....
over 20 million bottles have been sold...and only 15 cases of adverse reactions??? I would love the self righteous ass-clowns in the FDA show any of big pharma’s drugs that have anywhere NEAR comparable ratios...
they did the same thing with fen-fen in the 90s.
Why the delay?
Depends how recent the cases are. If the product was around for years with no reports of problems, and all of a sudden there are a couple of dozen reports of serious liver damage and/or kidney failure, it could be that a contaminant has been introduced into recent batches (think Chinese ingredients).
the one fatality is from 2007...with prior health problems
But what about all the non-fatal severe injuries?
most were women with priors...again this is 15 cases out of over 20million sold....more die and receive friendly gifts to the liver from asprin and tylenol in 4 months then Hydroxycut like supplements have in 11 years...fact...this is another control grab by the asshats in government to tax...
as far as i’ve learned from the news reports, most of these cases were spread out over a period of a few years. the one death was from 2007.
Ted Kennedy swears by it. ;’)
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