rhabdomyolysis

Safe Vs. Unsafe Weight-loss Products – FDA Warns Consumers to Stop Using Hydroxycut®

WASHINGTON, D.C. – The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc. According to the FDA advisory, some Hydroxycut products are associated with 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.

“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.

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.

There is always some inherent danger in relying on pills to lose weight. A good alternative may be a program like the Slimvia Revolutionary Weight Loss System, which is free of drugs and stimulants.

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FDA recently provided health care practitioners and patients with updated information about the risks and benefits of Crestor (rosuvastatin calcium), a cholesterol-lowering drug made by Astra-Zeneca Pharmaceuticals. Crestor, like all other statins, has been associated with rhabdomyolysis. The incidence of this effect is low, and the risk of serious muscle damage doesn’t appear to be greater for Crestor than for other statins. But as with all statins, the risk of myopathy increases with higher drug levels. So Crestor’s labeling has been changed to re-emphasize the risk of myopathy, particularly at the highest approved dose of 40 mg. The labeling also stresses the need to consider using lower starting doses in some patients. This may be particularly important when treating Asian Americans, since a large pharmacokinetic study found that this group of patients had drug levels about twice as high as a Caucasian control group, and that could increase their risk for myopathy. The revised labeling now recommends that the 5 mg dose of Crestor be considered as the starting dose for Asian-Americans, and also for others with predisposing factors for myopathy, including patients on cyclosporine and those with severe renal insufficiency.

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