The Hawaii State Department of Health is alerting local retailers and requesting the voluntary removal from sale of the product OxyELITE Pro pending an ongoing investigation of cases of liver failure and acute hepatitis.
DOH Food and Drug Branch began notifying retailers and distributors Tuesday to voluntarily suspend sales and remove the product from store shelves until further notice. The public is advised to discontinue use of the product at this time.
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.
"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."
Product manufacturer USPlabs says the supplement is safe and the Hawaii problems are mysterious. The company released the following statement:
"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."
Disease Outbreak Control Division spokesman Mark Berthold says the department is giving retailers a chance to do the right thing, but there may be sanctions for noncompliance later.
DOH is working closely with the U.S. Food and Drug Administration and Centers for Disease Control and Prevention throughout the ongoing investigation.