Hydroxycut Recalled by FDA

I heard this on the radio a little bit ago and verified it on the FDA website.  Fourteen different hydroxycut products have been pulled for serious liver problems ranging from enzyme elevation to death. 

I thought this was really important to get out in the milblogosphere because of the sheer number of soldiers I know who use hydroxycut products.  I know people use these products for weight loss, “cutting up”, staying awake on patrol, and a wide variety of other uses – recommended and otherwise.  I have even used the product in the past, although I can’t now because of flight status.  I have said it before, and now more than ever it holds true,  we don’t know what the long range effects of these “natural supplements” is.  They are not regulated by the FDA, no long term studies have been done, and the individual dosing varies based on several factors. They are rough on the kidneys and liver, as well as shifting the homeostasis of the body in order to increase metabolism, etc.  I don’t care if its Hydroxycut, NitRX, or any of the other slew of body building, weight loss, or metabolic supplements, you just can’t be 100% sure of their safety so use them with caution.  Being on dialysis at 45 or 50 because your kidneys shut down is not fun.  Hydroxcut was considered “perfectly safe” until today.

I don’t often do this, but since I have a small readership, Please pass this on to the blogs, twitter streams, etc of soldiers and people you know.

Anyway, off my soap box and onto the quotes:

FOR IMMEDIATE RELEASE
May 1, 2009

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

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:  www.fda.gov/MedWatch/report.htm
–Regular Mail: Use FDA postage paid form 3500 found at:  www.fda.gov/MedWatch/getforms.htm 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.
—The Food and Drug Administration