Hydroxycut^® Recall Due to Serious Health Risks

Consumers Warned by FDA to Stop Using Hydroxycut^® Products

May 13, 2009 — On the same day that the Food and Drug Administration issued a warning to consumers to stop taking Hydroxycut^® products, the dietary supplement’s manufacturer, Iovate Health Sciences Inc., voluntarily recalled 14 products in its Hydroxycut^® line. The 14 Hydroxycut^® products distributed in the U.S. by Iovate’s distributor, Iovate Health Sciences U.S.A. Inc., based in Blasdell, NY, 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

The FDA is recommending that those taking Hydroxycut^® stop using the dietary supplement and return the unused portion to where it was purchased.

Hydroxycut^® Side Effects May Cause Serious Health Problems Including Liver Damage

Marketed for weight–loss and bodybuilding, unwary consumers of Hydroxycut^® products may find themselves experiencing side effects that may ultimately result in serious liver damage. The FDA’s warning came after the agency received 23 reports of serious health problems including one death. Health problems reported included:

Jaundice—indicated by yellowing of skin and/or whites of eyes, brown urine
Elevated liver enzymes—an indicator of potential liver injury
Liver damage requiring transplant—one Hydroxycut^® user has received a transplant with another on a waiting list for a new liver

Although the recall is centered on the possibility of liver damage, other side effects creating possible health issues for Hydroxycut^® consumers may include:

Seizures
Cardiovascular disorders
Rhabdomyolysis—muscle damage that may lead to possible kidney failure
Nausea and vomiting
Light–colored stools
Excessive fatigue or weakness
Stomach or abdominal pain
Itching
Loss of appetite

Those who reported side effects were taking the dietary supplement according to the dosage listed on the packaging and until they started using Hydroxycut^® products, were relatively healthy. The exact ingredient or ingredients in the dietary supplement responsible for causing the side effects is not known at this time. The FDA is continuing to investigate. Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition said, “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.”

If you have used or are using Hydroxycut^® products and experience serious side effects, you or your healthcare provider are encouraged to report those side effects (adverse events) to the FDA’s MedWatch Adverse Event Reporting program. You may report through:

The MedWatch toll–free number at 800–FDA–1088 (800–332–1088)
Their mailing address at MedWatch, HF–2, FDA, 5600 Fishers Lane, Rockville, MD 20852–9787
Their online form, the MedWatch Online Voluntary Reporting Form.

For more information on the Hydroxycut^® recall please see FDA Warns Consumers to Stop Using Hydroxycut Products and Iovate Health Sciences U.S.A. Voluntarily Recalls Hydroxycut–Branded Products, both available on the FDA’s web site.

Dietary Supplements Do Not Come Under the Same Regulations as Medical Drugs

Prescription and over–the–counter drugs, unlike dietary supplements, need to be registered with or get approval from the FDA before being manufactured and sold to the public. Dietary supplement manufacturers are responsible for ensuring their products are safe under the requirements of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Once the products are on the market, the FDA monitors dietary supplements through voluntary aftermarket reports such as those they receive through MedWatch. Over the last few years, the FDA has attempted to impose stricter requirements when problems related to health and/or quality control issues arise. In 2004, dietary supplements containing ehpedra were banned after ephedra use was linked to heart attacks and strokes. In December 2008, the FDA tested and issued a warning against 69 weight–loss supplements that contained undeclared ingredients including the controlled substance sibutramine. Venom Hyperdive 3.0, a dietary supplement found to contain subtramine, was voluntarily recalled by its manufacturer, Applied Lifescience Research Industries, Inc. (ALR Industries), in late January 2009.

Legal Help If You or Someone You Know Has Experienced Side Effects After Taking Hydroxycut^® or Other Dietary Supplements

The attorneys at Brayton Purcell are currently evaluating personal injury cases stemming from health issues caused by the use of Hydroxycut^® and other dietary supplements. If Hydroxycut^® or another dietary supplement has harmed you or someone close to you, please contact our attorneys. We will evaluate your potential case free of charge and explore your legal options with you.