FDA Investigates Hepatitis Cases Linked to OxyElite Pro, VERSA-1 SupplementsOct 29, 2013
The U.S. Food and Drug Administration (FDA) recently announced that it will continue its probe of acute hepatitis cases tied to products labeled as OxyElite Pro and VERSA-1.
The FDA also continues to advise consumers not to use either product because they both contain aegeline, a new ingredient, and the manufacturer has not provided adequate evidence of its safety, said the agency.
In a warning letter sent to the manufacturer, USP Labs LLC, on October 11, 2013, the FDA informed the company that its dietary supplements OxyElite Pro and VERSA-1 were deemed to be adulterated, and that the failure to immediately cease distribution of both products could result in FDA enforcement action.
The letter explained that the products were deemed adulterated due to the inclusion of aegeline, which has not previously been in the food supply and for which there is no history of use or other evidence of safety.
The letter indicated that USP Labs had not provided the FDA with evidence—as legally mandated—that aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, is safe for use in dietary supplements.
A causal connection may exist between the use of OxyElite Pro and liver illnesses reported in Hawaii, the letter also noted.
The FDA is collaborating with the U.S. Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH) to investigate the increasing number of acute, non-viral hepatitis cases in Hawaii.
To date, 29 such cases, cause unknown, have been identified. The Hawaii DOH reported that 24 cases share a common link to OxyElite Pro. Of the 29 cases, 11 involved hospitalizations over acute hepatitis, two people underwent liver transplants, and one person died.
The CDC is investigating other cases of liver injury across the country that may be associated with this outbreak.
The CDC issued a number of recommendations, including that, as part of a thorough examination, clinicians evaluating patients with acute hepatitis query them about their use of dietary supplements. Other hepatitis symptoms, regardless of type, are similar and can also include fever, fatigue, nausea, vomiting, abdominal pain, joint pain, and yellow eyes.
On October 8, 2013, USP Labs LLC advised the FDA that it would voluntarily cease distributing OxyElite Pro and also advised that it believes counterfeit versions of OxyElite Pro are marketed in the U.S. and have been for some time. Based on this information, the FDA also is investigating whether counterfeit product could be the cause of any of the acute hepatitis cases.