OxyElite Pro, a fat burning supplement used by people keen to lose weight as well as bodybuilders, has been found to have an apparent causal side-effect of acute non-viral hepatitis. This causal relationship had been observed in 2011, but it is the recent outbreak in hepatitis cases in Hawaii that has renewed focus on the supplement, which is produced by USPLabs LLC, a Dallas-based firm.
The initial outbreak in Hawaii involved 29 victims, of whom 11 were admitted for about a week. 2 people required liver transplants while a third person, who was ineligible for liver transplant because doctors found she had breast cancer, died in the course of treatment.
24 of these victims were found to have consumed OxyElite Pro prior to their health problems. As of last week, the number of people with hepatitis suspected to have been caused by the supplement had risen to 41 in Hawaii, following an analysis of all previous hospital admissions. There have also been such 7 cases reported outside Hawaii.
As a matter of fact, New Zealand’s Ministry of Primary Industries has recently reported that there has been a hepatitis case that could be linked to OxyElite Pro, but investigations are ongoing to confirm whether there could be other factors at play.
The supplement has since been removed from shelves nationally, but can still be purchased online, and are not legally banned. However, the manufacturer has decided to willingly remove the product until issues concerning their safety are addressed.
The main ingredient that is being suspected of causing all these incidences of liver failure is 1, 3-dimethylamylamine, often abbreviated as DMAA. This compound was first introduced to the American market in 1948, but was discontinued in the 70s after concerns were raised about its safety. Its presence in supplements has been a matter of controversy, as it was allowed ostensibly because it existed as a natural isolate in geraniums, a claim which is constantly being refuted by new research; a 2012 analysis by a University of Utah Professor, using chiral gas and high performance liquid chromatography, showed that the DMAA in supplements is synthetic, and that DMAA did not exist in geranium extracts.
USPLabs however report that their products no longer contain DMAA, following an order by America’s Food and Drugs Agency (FDA) to remove products containing it. All supplements containing DMAA were made illegal in April 2013, and USPLabs has stated that it withdrew all products containing DMAA. OxyElite Pro wasn’t the only product to have DMAA, there were about 80 such products that were affected by the FDA directive.
In 2011, US servicemen who used DMAA containing OxyElite Pro suffered heart attacks and died. A postmortem examination of the two could not found a direct cause and effect relationship between DMAA and their cardiac events, but the researchers expressed concern that it could be exerting a synergistic effect when used with other compounds. The death of these two soldiers led to the product being banned from US military installations.
Subsequent studies have shown that DMAA can work with compounds as innocuous as caffeine (in coffee and energy drinks) to constrict blood vessels, leading to increased blood pressure and heart rate.
And What of This Aegeline?
According to recent updates, DMAA is not the only possible substance of interest in OxyElite Pro. FDA investigators are also concerned about the presence of aegeline, a chemical compound that can be isolated from the leaves of bael trees. This listed compound has attracted the attention of the FDA because the firm is yet to deliver reports about its safety, and the supplement introduced into the market without passing through the FDA, where it should have as this compound has never been previously used as a supplement.
The FDA thus needs to confirm that the aegeline (formally N-[2-hydroxy-2-(4-methoxyphenol) ethyl] 3-phenol-2-propenamide) present in OxyElite Pro is actually a natural product or a chemically altered compound.
OxyElite Pro isn’t the only USPLabs product being investigated by the FDA. The firm’s VERSA-1, used by bodybuilders, has been reportedly found with traces of aegeline, which should reviewed first before being introduced into the market. FDA investigations in the past revealed that some VERSA-1 had traces of an anabolic steroid, methylclostebol. Tests conducted by labs hired by USPLabs turned up negative for the steroid.
Use Supplements Cautiously
While we wait for the FDA to clarify whether the tragedy in Hawaii was caused by a contaminated batch, or if all OxyElite Pro supplement are tainted with a harmful compound, it is best to avoid consuming the supplement.
As usual, consult with your physician before taking any supplements.