FDA Warns Consumers to Stop Using Hydroxycut Products

[NicNak]

FDA Warns Consumers to Stop Using Hydroxycut Products
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury
FDA News

The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:

• 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

Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.

Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

Online: MedWatch Online Adverse Event Reporting
Regular Mail: Use FDA postage paid form 3500 found at: MedWatch - Download reporting forms and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 800-FDA-0178
Phone: 800-FDA-1088​

The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

For more information:

• Hydroxycut Products
  
• Dietary Supplements -- Overview
  
• FDA 101: Dietary Supplements
  
• NIH Office of Dietary Supplements

 

[Budoaiki]

I found this article from the Globe and Mail while perusing the World News site's health section:

Health Canada reviewing supplement deemed dangerous by U.S. officials
Globe and Mail
May 1, 2009

TORONTO (Associated Press) — Health Canada revealed Friday it has received some adverse reports about Hydroxycut dietary supplements, as U.S. health officials warned people to immediately stop using the products.

The U.S. Food and Drug Administration warned dieters and body builders against using Hydroxycut dietary supplements after it received reports linking some of the widely sold Canadian-made products to cases of serious liver damage and at least one death.

The Canadian maker of the dietary supplement has agreed to recall 14 Hydroxycut products in the U.S.

But while Hydroxycut products are not authorized for sale in Canada, Health Canada said it has received 17 adverse reaction reports associated with Hydroxycut products in Canada.

The reports relate to the cardiovascular, respiratory, gastrointestinal and neurological systems, a Health Canada statement said. It has not received reports of liver injury, as officials in the United States have.

“Health Canada is reviewing the situation in Canada and has been in contact with the FDA regarding this matter,” the department said in an emailed statement.

“Health Canada will provide Canadians with any new safety information when the review is completed.”

Available in grocery stores and pharmacies in the U.S., Hydroxycut is advertised as being made from natural ingredients. At least nine million packages were sold last year, the FDA said.

Dr. Linda Katz of the FDA's food and nutrition division said the agency has received 23 reports of liver problems, including the death of a 19-year-old boy. The teenager died in 2007 and the death was reported to the FDA this March.

Other patients experienced symptoms ranging from jaundice, or yellowing of the skin, to liver failure. One received a transplant and another was placed on a list to await a new liver. The patients were otherwise healthy and their symptoms began after they started using Hydroxycut, regulators said.

Iovate Health Sciences, the Oakville, Ont., company that makes the diet pills, said in a statement that the 2007 death of the teenager was not caused by Hydroxycut. The statement gave no details.

A statement posted on the Hydroxycut website Friday said Iovate analyzes individual ingredients and undertakes medical, scientific and toxicological literature reviews on the safety of the ingredients.

“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 statement says.

Hydroxycut is used by people trying to shed pounds and by body builders to sharpen their muscles.

Hydroxycut Cleanse and Hoodia products are not affected by the recall.

In the U.S. dietary supplements aren't as tightly regulated by the government as medications.

Manufacturers don't need to prove to the FDA that their products are safe and effective before they can sell them to consumers. But regulators monitor aftermarket reports for signs of trouble, and in recent years companies have been put under stricter requirements to alert the FDA when they learn of problems.

Health Canada said consumers should not use unauthorized health products “as they may pose a risk to health.” Authorized health products bear either an eight-digit drug identification number, a natural product number or a homeopathic medicine number on the label.

Katz said it has taken so long to get a handle on the Hydroxycut problem because the cases of liver damage were rare and the FDA has no authority to review supplements before they're marketed.

“Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow,” she said.

The FDA relies on voluntary reports to detect such problems, and many cases are never reported, officials acknowledge.

Health officials said they have been unable to determine which Hydroxycut ingredients are potentially toxic, partially because the formulation of the products has changed several times. A medical journal report last month raised questions about one ingredient, hydroxycitric acid, derived from a tropical fruit. The article said it could potentially damage the liver.

 

[suewatters1]

I went to Shopper Drug Mart this morning and they still had the Hydroxycut products on their shelf. I told one person in in the pharmacy who works the cash that they were talking about this on the news last night about taking it off the shelves.
But I guess it's still allowed on the shelves in Canada.

Sue

 

[NicNak]

I went to Shopper Drug Mart this morning and they still had the Hydroxycut products on their shelf. I told one person in in the pharmacy who works the cash that they were talking about this on the news last night about taking it off the shelves.
But I guess it's still allowed on the shelves in Canada.

Sue

Is it possable it was this you saw?

Hydroxycut Cleanse and Hoodia products are not affected by the recall.

 

[suewatters1]

I don't think so but I am going back tomorrow to buy stuff on sale so I will double check. Because there was more then 1 Hydoxycut product on their shelf.

Sue

 

[Retired]

Health Canada reports that it is currently evaluating the FDA's recall of this product HERE as of May 1, 2009.

Considering the seriousness of the reported adverse reactions, users of this product would be well advised to at least discuss continuing using it with their doctor, and consider not using it until the situation is clarified.

It would seem that as of today, Health Canada has not issued a recall advisory, so Canadian stores would not be required to remove it from their shelves at this time.