Liver Failure Associated with the Dietary Supplement LipoKinetix

What is the problem and what is known about it so far?

Dietary supplements, unlike drugs, are not evaluated by the U.S. Food and Drug Administration (FDA) before they are released for sale. In general, as long as manufacturers do not claim that their product cures or controls a particular disease, that product can be marketed as a dietary supplement. Adverse effects sometimes occur with use of dietary supplements, and manufacturers are not required to collect data about adverse effects or to report this information to the FDA. Information about adverse effects becomes public knowledge only when a physician or patient reports an association between the product and an adverse reaction to the FDA or to a medical journal.

LipoKinetix is sold as a dietary supplement. The manufacturers assert that LipoKinetix promotes weight loss by “mimicking exercise.”

Why did the researchers do this particular study?

To report a possible connection between LipoKinetix and acute liver failure.

Who was studied?

Seven previously healthy people who developed liver failure while taking LipoKinetix.

How was the study done?

All seven patients were evaluated for other causes of liver failure, including viral hepatitis and other viral infections, autoimmune disease (a type of disease in which the immune system attacks other parts of the body), and ingestion of potentially hepatotoxic drugs.

What did the researchers find?

All seven patients developed severe liver injury within 3 months of starting LipoKinetix use. Symptoms included fatigue and abdominal pain; blood test results were abnormal. None of the patients had evidence of viral hepatitis or other viral infections or autoimmune disease. Three patients were not taking any other drugs before symptoms of liver disease started. Two of four patients (who were using other dietary supplements) stopped taking all supplements when they developed liver disease and were able to take them again (excluding LipoKinetix) without difficulty after liver failure resolved. All patients recovered once they stopped taking LipoKinetix.

What were the limitations of the study?

Five of the seven patients purchased LipoKinetix from the same health food store. The two other patients were acquaintances who had purchased the product through the Internet.

What are the implications of the study?

These observations highlight the dangers of our current system of allowing products to be marketed as dietary supplements without proof of safety and in combinations of ingredients not previously used. After a possible association between LipoKinetix and liver damage was reported, the FDA wrote to the manufacturer urging withdrawal of the product. It also wrote warning letters to health care professionals and consumers about the potential adverse health effects of LipoKinetix.