The FDA along with the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH) are investigating a growing number of reports of acute non-viral hepatitis in Hawaii linked to products labeled OxyElite Pro. A number of previously healthy individuals developed acute hepatitis and sudden liver failure of unknown cause after using the dietary supplement for weight loss or muscle building. Symptoms of all types of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay colored bowel movements, joint pain, yellow eyes, and jaundice.
Thus far, clinicians have reported 45 patients to the Hawaii DOH in response to a public health alert. Of those, 29 patients, including the original seven, were confirmed to have acute hepatitis after using OxyElite Pro and VERSA-1. The median age of the 29 patients is 33 years; 14 (48%) are male. Two cases have received liver transplants and one person has died. The CDC is also looking at other cases of liver injury nationwide that may be related.
The FDA advises consumers to discontinue using any dietary supplement products labeled as Oxy Elite Pro and VERSA-1 while the investigation continues. OxyElite Pro and VERSA-1 are distributed by USP Labs LLC of Dallas, Texas, and are sold nationwide through a wide range of distribution channels, including the internet and retail stores that sell dietary supplements. In a warning letter issued to USP Labs LLC of Dallas, Texas, on October 11, 2013, the FDA informed the company that the dietary supplements OxyElite Pro and VERSA-1 are deemed to be adulterated, and that failure to immediately cease distribution of these products may result in enforcement action by the FDA. Specifically, USP Labs failed to provide the FDA with evidence, as required by law, that aegeline was safe for use in its dietary supplements.
The FDA is inspecting the facilities involved in manufacturing the product and reviewing production and product distribution records. Because USP Labs LLC has informed FDA that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been on the US market for some time, FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis.
See the FDA Outbreak Report
Also see the CDC Health Advisory
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, April 2013 Report: Complementary and Alternative Medicine: Practitioner Liability