A breakout of acute non-viral hepatitis in Hawaii has prompted the Food and Drug Administration to issue a safety alert for the dietary supplement OxyElite Pro — the only common thread in 24 cases, including one fatality.
Since May, the state of Hawaii has seen 29 cases of acute hepatitis without any known cause. According to the Hawaii Department of Health, 24 of those who fell ill had taken or been taking OxyElite Pro, a popular “fat-burner” supplement touted as a metabolism booster and weight loss aid.
According to the FDA, at least 11 people from the 29 cases were hospitalized, two have required liver transplants, and one died. The agency is in the process of analyzing the patients’ product samples to determine whether they were tainted or possibly are counterfeit.
USPlabs, distributor of OxyElite Pro, has told the FDA it believes fake versions of the product are being sold in the U.S. and “have been on the market for a while.”
In April, USPlabs tweaked the formula for OxyElite Pro, removing a controversial ingredient, 1,3-dimethlyamylamine, or DMAA, from the best-seller. The change upset many fans of the popular product, prompting them to buy back stocks on the Internet and elsewhere.
DMAA has been associated with elevating blood pressure and causing health problems ranging from heart attacks to shortness of breath, according to the FDA. It also has been linked with kidney and liver failure.
The Centers for Disease Control and Prevention is investigating whether other cases have occurred nationwide.
Symptoms of hepatitis include fever, fatigue, loss of appetite, nausea, vomiting, joint or abdominal pain, dark urine, yellow eyes and jaundice.
The FDA is advising consumers to stop using anything labeled as OxyElite Pro while officials investigate. It also is advising those who think they have become ill as a result of taking a dietary supplement to notify their doctor.