The Hawaii Department of Health (DOH) is currently investigating 29 cases of acute hepatitis and liver failure that have occurred in the state from May through October 2013 and may be related to the use of diet supplements for weight loss and/or muscle building.
The cases under investigation include two individuals that have undergone liver transplants and one death.
USPlabs says they have no knowledge of any link between their supplements and liver failure, but are doing this voluntarily until the U.S. Food and Drug Administration, Centers for Disease Control and Prevention and the DOH can figure out the cause.
DOH on Tuesday alerted Hawaii retailers and requested a voluntary removal of the product OxyElite Pro pending the investigation.
The public is advised to discontinue use of the product at this time.
"Twenty-four cases reported using OxyElite Pro before their illness," said Dr. Sarah Park, State Epidemiologist. "No other supplement or medication has been identified in common among more than two patients."
"The department continues to urge people who use dietary or nutritional supplements for weight loss and/or muscle gain to talk with their doctor or health care provider," said Health Director Loretta Fuddy. "Anyone who develops symptoms such as abdominal pain or discomfort, fatigue, loss of appetite, nausea and /or vomiting, and yellow skin or eyes, should consult their doctor immediately."
DOH is working closely with the U.S. Food and Drug Administration and Centers for Disease Control and Prevention throughout the ongoing investigation.
Here is the press release from USPlabs:
"The company stands by the safety of all of its products. The company is cooperating with FDA on reports coming out of Hawaii. The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro in all of the years our products have been in the market. We know of no credible evidence linking OxyELITE Pro to liver issues. The ingredients have been studied for safety, are consumed in the food supply and widely used in dietary supplements. The studies and consumption history show no negative liver issues. Due to multiple products within the OxyELITE Pro brand, it may be confusing as to which products are being looked at.
The specific products are the original OxyELITE Pro with DMAA, OxyELITE Pro with the "Purple Top" and OxyELITE Pro Super Thermo Powder. The original version with DMAA has not been manufactured or distributed since early 2013. Out of an abundance of caution, the company has ceased domestic distribution of OxyElite Pro with the Purple Top and OxyElite Pro Super Thermo Powder until the investigation has been completed. The company continues to believe these versions are safe and are not the cause of the cluster of liver toxicity that has occurred in Hawaii."
The FDA released the following recommendations:
The FDA advises consumers to stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues. Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178