Acute Hepatitis Health Advisory Linked to OxyElite Pro SupplementOct 9, 2013
The U.S. Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH) are investigating growing reports of acute, non-viral hepatitis in Hawaii that may be tied to the supplement, OxyElite Pro, the FDA just announced.
The Hawaii DOH reports that 24 reported illnesses are linked to OxyElite Pro, a supplement distributed by USPlabs LLC of Dallas, Texas, and sold nationwide through a number of distribution channels, including the Internet and retail stores specializing in dietary supplements.
In all, there have been 29 cases of acute, non-viral hepatitis with an unknown cause that have been identified in Hawaii. Of these, 11 have required hospitalization for acute hepatitis, two people had to have liver transplants, and one person died. The CDC is reviewing other cases of liver injury nationwide that may be related.
Hepatitis symptoms, regardless of the type, can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice.
An epidemiological investigation is under way and being conducted by the Hawaii DOH and the CDC. As part of its related probe, the FDA is reviewing the medical records and histories of patients identified by the Hawaii DOH, product samples collected from some of these patients, the facilities involved in manufacturing the product, and production and product distribution records. Because USPlabs LLC has informed the FDA that it believes counterfeit versions of OxyElite Pro are being marketed in the U.S. and have been on the U.S. market for some time, the agency is also investigating if counterfeit products are tied to any of the acute hepatitis cases.
As of her last report, state epidemiologist Dr. Sarah Park said that all of the cases have involved young to middle-aged adults who felt suddenly ill and needed to be hospitalized for some stage of liver failure. Also, they “have nothing in common among them except for the fact that they all took a dietary supplement, a nutritional supplement, for the purpose of weight loss or muscle-building,” she told KHON.com.
All of the patients took the supplements in the past six months, with cases reported in just about every Hawaiian county. The cases so far have involved patients with no infectious causes, no history of high-risk social activities, and no identified commonly expected risk factors that would point to liver failure, the Star Advisor reported.
“OxyElite Pro” is described on the firm’s website as an update to the prior “OxyElite Pro Super Thermogenic.” The website also indicates that the new, re-named product has a purple top and may be referred to as the “Purple Top OxyElite Pro.” The ingredients, according to the product label, are: Bauhinia Purpurea L. (Leaf and Pod) Extract, Aegeline, Norcolaurine HCI, Hemerocallis Fulva (Flower) Concentrated Extract, and Yohimbe (Pausinystalia Hohimbe) (Bark) Extract (AlphaShred™). The original version contained Dimethylamylamine HCl (DMAA), which has since been removed. The new version now includes additional caffeine and Noroclaurine HCl, which the website describes as a higenamine that goes under the trade name Norcoline™. According to the website this ingredient is described as “a very safe, yet effective, fat targeting agent. Great for focus too!”
The FDA advises consumers to stop using any dietary supplement product labeled as OxyElite Pro while the investigation is ongoing and recommends that any consumers who believe they have been harmed by using a dietary supplement contact their health care practitioner.