Hepatitis Outbreak Linked to USPlabs Dietary Supplement Shows Limitations of FDA MedWatch Program

The hepatitis outbreak tied to OxyElite Pro has raised questions around MedWatch, FDA’s post-market surveillance program that was launched in 1993.

Josh Long, Associate editorial director, Natural Products Insider

June 20, 2016

2 Min Read
Hepatitis Outbreak Linked to USPlabs Dietary Supplement Shows Limitations of FDA MedWatch Program

On Sept. 6, 2013, a physician at The Queen’s Medical Center in Honolulu filed a report with FDA’s MedWatch adverse event reporting (AER) program.

The details were alarming. Six patients taking a dietary supplement had suffered liver injuries, and half of them needed liver transplants.

“Reporter is concerned that product is easily available in stores (such as GNC and Vitamin Shoppe) and on the Internet," noted the MedWatch report. “She thinks that the reformulated product is now associated with severe liver damage."

Half of the patients referenced in the document were first seen as early as May or June 2013, months before FDA learned of the illnesses in the early fall.

Sixty-five days later, FDA announced USPlabs LLC was recalling certain OxyElite Pro products, a weight loss supplement that was linked to an outbreak of hepatitis and liver damage that sickened consumers in Hawaii and the mainland United States.

A separate MedWatch report involving OxyElite Pro was submitted several months earlier in 2013 by a physician, FDA records show. It stated, “Patient hospitalized for acute liver failure necessitating emergent liver transplant after reported use of oxy-elite energy/weight loss supplement, and no other evidence of underlying liver disease or causes." The male patient suffered the adverse event just four days earlier than the date of the March 24, 2013 report, but the document doesn’t specify the hospital, town or city where the person experienced the liver failure.

The outbreak tied to OxyElite Pro—what the U.S. Centers for Disease Control and Prevention (CDC) described as “one of the largest reported outbreaks of liver disease associated with a dietary supplement to date"—has raised questions around MedWatch, FDA’s post-market surveillance program that was launched in 1993. In research published last year in the journal Public Health Reports, FDA officials acknowledged “a significant lag separated the occurrence and the reporting of cases."

“Although patients began to develop severe hepatitis in May 2013, the Food and Drug Administration (FDA), whose job it is to remove dangerous supplements from store shelves, did not learn of the cases until mid-September, four months later," wrote Pieter Cohen, M.D., an assistant professor of medicine at Harvard Medical School and renowned critic of dietary supplement regulations, in a 2014 article published in The New England Journal of Medicine.

Click the following text link to continue reading about the hepatitis outbreak and FDA, as well as a Digital Magazine examining the regulatory issues surrounding MedWatch and adverse event reporting.

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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