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OxyElite Pro Linked to Nearly 100 Hepatitis Liver Injuries

OxyElite Pro Linked to Nearly 100 Hepatitis Liver Injuries

April 7, 2014 — The New England Journal of Medicine has published a critique of the U.S. Food and Drug Administration (FDA) oversight of dietary supplements, citing a recent outbreak of hepatitis linked to OxyElite Pro as an example.

According to CDC data in February 2014, OxyElite Pro has been linked to 97 cases of non-viral hepatitis (non-contagious liver inflammation) in at 16 states, resulting in 47 hospitalizations, three liver transplantations, and one death.

The outbreak of liver inflammation occurred soon after OxyElite Pro was re-formulated. The original formula contained 1,3-dimethylamylamine (DMAA), a synthetic stimulant drug linked to cardiovascular events. DMAA was banned by the Department of Defense in 2011, but it took the FDA another 16 months to gather enough evidence to issue a safety warning. It took an additional year for the manufacturer of OxyElite Pro to agree to re-formulate the product.

The author of the critique, Dr. Pieter Cohen, is general internist at Cambridge Health Alliance and assistant professor of medicine at Harvard Medical School. He says the FDA must improve a “woefully inadequate system for monitoring supplement safety.” Hundreds of supplements have been found to contain pharmaceutical drugs, including new stimulants, banned weight-loss medications, analogues of illegal drugs, and more.

The FDA currently relies on MedWatch, a surveillance system that relies on voluntary adverse event reports. Dr. Cohen believes an appropriate public health response would be expedited if more public health organizations — local health departments, poison control centers, the CDC, the Department of Defense, and others — could share adverse event data in real time.

Dr. Cohen and colleagues discovered a new analogue of methamphetamine (N,α-DEPEA), which was an ingredient in Craze workout supplements until late last year. FDA scientists discovered another analogue of amphetamine (β-MePEA) in nine workout supplements. These drugs have never been studied in humans, but they are sold as “natural” products. While most N,α-DEPEA has been taken off the market, β-MePEA remains widely available.

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