Weight-loss Supplement Linked to Nearly 100 cases of Hepatitis
The supplement industry has always been a buyer-beware market due to a lack of manufacturer oversight and regulation before products reach the marketplace. The weight-loss supplement, OxyElite Pro, manufactured by USPLabs, illustrates a recent example of this risk. The product claims to be a thermogenic fat-burner to aid in weight loss, but it seems to have the potential to negatively impact organ cells outside of adipose tissue. It has been directly linked to 97 cases of hepatitis; nearly half of which required hospitalization, three created the need for liver transplantations and one resulted in death. These findings were presented in a paper authored by Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School and a general internist at Cambridge Health Alliance in the New England Journal of Medicine (April 2014). Hepatitis is a serious medical condition defined by inflammation of the liver caused by a range of viruses; or less commonly, bacteria, funguses or parasites. Non-pathogenic causes include tainted drug/supplement intake, excessive alcohol consumption, fatty liver disease as well as autoimmune or metabolic disorders.
Isolated claims of user-illness began in May of 2013, but the Food and Drug Administration (FDA) was not made fully aware until four months later, when physicians reported a cluster of liver illnesses in Hawaii. USPLabs stopped selling the product in October 2013. Health officials suspect that the compound aegeline added to the supplement caused the illnesses, Cohen said. Because the FDA only regulates supplements after they reach the market, companies are not required to prove that their products are safe and effective before marketing them. "This really points to the fact that there's no safety testing … before a new ingredient shows up in a supplement in the United States," Cohen said. "Guess who's the experimental animal — the consumer."
Cohen explains that dangerous products should be identified and removed quickly, but this is often not the case if the FDA does not receive the associated reports. Cases might be reported to a poison control center, which does not communicate with the FDA, or they might not get reported at all. "Dangerous supplements remain on store shelves for weeks, months or years because the FDA has a fractured system for monitoring supplements”, Cohen said. He proposes that all dietary supplements should be registered, and information about their ingredients should be incorporated into a database maintained by the FDA and poison centers. Under this organization, if a person has an adverse reaction to a supplement, it would be reported to a response team made of up doctors, toxicologists, pharmacologists and chemists. "In the situation where we know that some supplements out there may be dangerous, we'd better have a really good system" to detect them, Cohen concludes.
The following products were recalled:
- OxyElite Pro Super Thermo capsules
- OxyElite Pro Ultra-Intense Thermo capsules
- OxyElite Pro Super Thermo Powder (all flavors)