Hepatitis Cases Tied to Diet Supplement

Non viral hepatitis cases linked to OxyElite Pro dietary supplement in Hawaii

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Hepatitis, or inflammation of the liver, is often caused by infection with one of the hepatitis viruses. But reports are surfacing of a non-viral form of the disease with connections to a dietary supplement.

According to the US Food and Drug Administration (FDA), 29 reports of non-viral hepatitis have been discovered in Hawaii, and 24 of the cases share a link to a product called OxyElite Pro.

The FDA has issued a safety alert and recommended that the public halt use of products with this label while the investigation is underway. 

"Ask your doctor which supplements are best for you."

Symptoms of hepatitis can include dark urine, nausea, vomiting, fever, fatigue, joint pain, clay or gray-colored bowel movements and jaundice (a yellowing of the skin and eyes).

Hepatitis can lead to serious health issues such as liver failure, as seen in newly reported cases.

According to the FDA, 11 of the 29 Hawaiian cases have resulted in hospitalization. Two cases have resulted in liver transplants and one death has occurred.

The FDA reported that the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health are also involved in the investigation, which is ongoing. CDC is looking into other cases of liver issues around the US to determine if more illnesses are related.

"OxyElite Pro is distributed by USPlabs LLC of Dallas, Texas, and is sold nationwide through a wide range of distribution channels, including the internet and retail stores that sell dietary supplements," the FDA reported.

The FDA noted that it is analyzing product samples from patients and inspecting facilities involved with manufacturing OxyElite Pro, which is marketed as a weight loss and muscle building supplement.

"Because USPlabs LLC has informed FDA that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been in the US market for some time, FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis," the FDA explained.

"The FDA advises consumers to stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues," the FDA recommended. "Consumers who believe they have been harmed by using a dietary supplement should contact their healthcare practitioner."

Both patients and healthcare professionals can report side effects or adverse effects of products like supplements to the FDA.

Review Date: 
October 10, 2013
Last Updated:
October 11, 2013