Department of Health Requests Voluntary Removal of Oxyelite Pro Supplement from Sale

News Release from DoH October 8, 2013

HONOLULU -- The Hawaii State Department of Health (DOH) 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 today began notifying retailers and distributors 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.”

DOH is working closely with the U.S. Food and Drug Administration and Centers for Disease Control and Prevention throughout the ongoing investigation.

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DVIDSHub: OxyELITE, not so elite: MCCS bans sale of dangerous supplement

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News 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."

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FDA 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