April 7, 2014 — Nearly 100 people in 16 states have developed acute hepatitis (non-contagious liver inflammation) after using OxyElite Pro, according to a paper published in the New England Journal of Medicine.
Dr. Pieter Cohen, assistant professor of medicine at Harvard Medical School and a general internist at Cambridge Health Alliance, is calling on the U.S. Food and Drug Administration (FDA) to improve a “woefully inadequate system for monitoring supplement safety.”
OxyElite Pro has been associated with 97 cases of hepatitis, resulting in 47 hospitalizations, three liver transplantations, and one death. Although the first cases appeared in May 2013, the FDA did not learn of the cases until mid-September.
The original formula for OxyElite Pro contained 1,3-dimethylamylamine (DMAA). In 2011, the Department of Defense removed supplements containing DMAA after finding it in the bloodstream of several soldiers who had cardiovascular events during training. It took the FDA another 16 months to gather sufficient data to alert consumers about the health risks of DMAA.
The biggest manufacturer fought the FDA for another year before finally agreeing to re-formulate OxyElite Pro — then the re-formulated product was linked to a massive outbreak of hepatitis. Despite the FDA efforts, DMAA remains in many supplements. Three Olympians were banned for using DMAA at the 2014 Winter Olympics, and all three said they were inadvertently consuming it in supplements.
Dr. Cohen argues that the MedWatch surveillance system, which relies on voluntary adverse event reports, rarely provides sufficient data to detect serious adverse events from dietary supplements. Instead, outbreaks have been discovered by local public health departments, the Centers for Disease Control (CDC), or the Department of Defense. An appropriate public health response might be expedited if these organizations could share adverse event data in real time.
Dr. Cohen and colleagues also discovered an amphetamine-analogue (N,α-DEPEA) in Craze, a workout supplement that was widely available in retail stores like Walmart until late last year. FDA scientists discovered another amphetamine-analogue (β-MePEA) in nine other supplements.
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