Two class action lawsuits have been filed in the wake of the recall of Hydroxycut, a popular weight-loss supplement that has been linked to liver damage and other life-threatening side effects.

The suits, filed in Canada and Tennessee, accuse Iovate Health Sciences, which manufactures Hydroxycut, of failing to warn of the drug's dangers or take proper precautions to protect its users.

Hydroxycut was voluntarily recalled on May 1 after the Food and Drug Administration (FDA) identified numerous health risks posed by the drug. The Administration received 23 complaints of liver damage resulting from use of the product, ranging from jaundice to the need for a transplant. A 19-year-old man died in March 2007 from liver failure apparently caused by Hydroxycut; amazingly, the death was not reported to the FDA until March of this year.

The drug poses other serious risks, including heart failure, seizures, and rhabdomyolysis, a muscle condition where muscle fibers break down to the point that they are released into the bloodstream. In some serious cases, this condition can lead to kidney failure.

The Canadian suit, filed on May 4, defines a class of any Canadian who purchased Hydroxycut after May 1, 2003. The suit alleges that Iovate failed to warn on the label of Hydroxycut's possibly serious side effects. The suit seeks $20 million plus punitive damages.

The Tennessee suit, filed on May 20 in the United States District Court for the Middle District of Tennessee, defines a class of anyone who purchased a Hydroxycut product. The lead plaintiffs, all from Tennessee, spent varying amounts of money on Hydroxycut products before the recall was announced. The suit alleges counts under negligence, breach of express and implied warranties, fraud, failure to warn, unjust enrichment and violations of the Tennessee Food, Drug and Cosmetic Act, among others.

The plaintiffs in the Tennessee action experienced a number of symptoms as a result of taking the drug, including nausea, vomiting, abdominal pain, headaches, and extreme fatigue.

Very popular

The extremely popular drug currently accounts for 90% of weight-loss supplement sales. In 2008, Iovate sold more than 9 million units of the drug.

The FDA's advisory states that, Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk. Shortly after the statement was released, Iovate voluntarily recalled the drug from the market.

The FDA said that, while liver damage is rare, those affected did not exceed the recommended dosage of the drug. The Administration has yet to determine why the drug causes such damage.

The Los Angeles Times reported this week that an Army radio operator had to be medically discharged after suffering from a serious case of rhabdomyolysis, most likely as a result of using Hydroxycut during a three-month period in 2007. Robert Tropea suffered from serious muscle aches and had black urine. Moreover, tests showed extremely serious organ and muscle damage.

Tropea conceded to the Times that he didn't recognize a lot of the ingredients listed on the supplement's label. But they were selling it as something safe, and I took what they said and ran with it, he said.

The recall points to the serious problems with oversight of over-the-counter dietary supplements. Under the Dietary Supplement Health and Education Act (DSHEA), which took effect in 1994, it is the manufacturer's responsibility to ensure that a given drug is safe for consumer consumption. While the company is technically required to rely on adequate evidence in reaching this conclusion, they do not have to provide this evidence to the FDA unless the drug contains an entirely new dietary ingredient. Whether the Hydroxycut controversy will change this shoddy procedure remains to be seen.

A statement on the website explains that, 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.

Recalled products

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

The FDA 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.