The FDA continues to investigate dietary supplement OxyELITE Pro following dozens of reports of acute hepatitis and liver failure in Hawaii. On Friday, October 11th, the FDA issued a warning letter to USPlabs, the Dallas-based manufacturer of OxyELITE Pro.
In the warning letter, the FDA informed USPlabs that dietary supplements OxyELITE Pro and VERSA-1 are considered adulterated drugs because they contain aegeline, an ingredient for which USPlabs has not provided sufficient evidence of safety; therefore, failure to immediately cease distribution of OxyELITE Pro and VERSA-1 may result in enforcement action by the FDA.
The FDA explained that confirming the safety of aegeline is particularly important in light of the FDA’s findings regarding OxyELITE Pro and an outbreak of liver failure and acute hepatitis in Hawaii. According to the FDA, several findings suggest a causal connection between OxyELITE Pro and the mounting cases of liver illness in Hawaii.
Until further notice, the FDA advises consumers not to use any dietary supplements labeled OxyELITE Pro or VERSA-1. In addition, the Hawaiian Department of Health, FDA, and CDC urge people to immediately contact a healthcare provider regarding the following symptoms:
- Loss of appetite
- Jaundice (yellow skin or eyes)
- Joint pain
- Pale bowel movements
- Dark urine
- Abdominal pain/discomfort
Andrews Thornton Higgins Razmara encourages patients and loved ones who have been affected by OxyELITE Pro, VERSA-1, or any other dietary supplement to contact us for a free case evaluation at www.andrewsthornton.com or toll free at 1-800-644-1734.