Personal Injury Law

FDA Warning: Recall of Hydroxycut Products

By Jane Akre

Recall of Hydroxycut Products

They are marketed as products for weight loss, enhanced energy, and fat-burning. Now they should be quickly taken off the shelves.

On Friday, the Food and Drug Administration (FDA) issued a warning for consumers to stop using Hydroxycut Weight Loss Products because of their link to one death and the possibility of liver injury. The company has agreed to a recall of 14 products including Max Drink Packets, Caffeine-Free Rapid Release Caplets, and Max Aqua Shed.

There have been 23 reports of liver injury reported to the FDA, including jaundice and elevated liver enzymes. Other adverse rerports include heart problems, seizures and rhabdomyolysis, another type of muscle damage.

Consumers who feel ill are urged to seek medical attention. Liver problems can show up as symptoms such as jaundice, nausea, vomiting, light-colored stools, tiredness, abdomonal pain, itchiing and loss of appetite.

Deaths Reported 

One 17-year-old boy taking the Hydroxycut products died in 2007, and his death was reported to the FDA in March.

The National Post, an Ontario, Canada newspaper, reports in this reprinted story, on the case of a healthy 26-year-old mother of two who was taking the herb ephedra, once an ingredient in Hydroxycut, when she died in her Detroit office of a heart arrhythmia.

Muscletech Research and Development, a Toronto-area firm and its founder, 33-year-old multi-millionaire, Paul Gardiner, were later sued by her widower. The paper reports that Gardiner, with a high school education, grossed $350-million a year through his weight loss products and false advertising, using a pregnant fitness model for the "before" and after giving birth for the "after" photos. The company later filed for bankruptcy protection under a slew of lawsuits. 

The company then moved its assets into a new firm, Iovate Health Sciences which says it makes 750 items that are sold in more than 70 countries.  That company too is facing a long list of personal injury and patent, trademark lawsuits.

Iovate Products

Iovate Health Sciences Inc. of Oakville, Ontario has agreed to recall Hydroxycut products from the market, "in an abundance of caution". The 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

Iovate says consumers should return the products to the place of purchase for a refund.

Ephedra

Ephedra was banned by the government in 2004 after a host of heart attacks, strokes, and multiple district litigation.

Since the Hydroxycut formula has changed over the years, its difficult to know which one is causing the liver problems but the Huffington Post reports the Consumer Reports has found an ingredient called hydroxycitric acid, which comes from tropical fruit, has been linked to liver problems in a medical journal study. 

In a statement issued today, the trade group for the supplement industry, Council for Responsible Nutrition says it supports the FDA's decision.  

 The statement by Steve Mister, president and CEO of CRN says:  "The potential safety problem was discovered by an adverse event reporting (AER) system that gives FDA the ability to monitor for signals or patterns of adverse events that could identify potential safety problems.  It should be noted that adverse events do not establish causality, nor is enough known at this point to determine whether the adverse events associated with these products were idiosyncratic, dose-related, ingredient-related or simply random.  CRN believes FDA took appropriate action to protect consumers, while not drawing speculative conclusions until further investigation is completed."  #

Full post as published by InjuryBoard on May 04, 2009 (boomark / email).